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Incidence OIRD Medical and Trauma Patients

Study Description
Brief Summary:
The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.

Condition or disease
Respiratory Depression Sedation

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of OIRD in Medical and Trauma Patients on the General Care Floor Receiving PCA or Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : October 29, 2019
Estimated Study Completion Date : November 29, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
    The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

  2. Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
    The percentage of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

  3. Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
    The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.


Secondary Outcome Measures :
  1. Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
    The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

  2. Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
    The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

  3. Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
    The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.


Other Outcome Measures:
  1. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    The number of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study

  2. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    The percentage of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study

  3. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    The characteristics of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study

  4. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The number of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study

  5. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The percentage of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study

  6. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The characteristics of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study

  7. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The number of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study

  8. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The percentage of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study

  9. Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The characteristics of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target study population will be hospitalized, adult medical or trauma patients on the general care floor receiving patient-controlled analgesia or nurse administered intravenous opioids for acute pain.
Criteria

Inclusion Criteria:

  1. Spontaneously breathing adults 18 to 89 years of age
  2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
  3. Admitted to the general care floor from the emergency department
  4. Able to provide written informed consent

Exclusion Criteria:

  1. Age is less than 18 years or greater than 89 years
  2. Transfer to the general care floor from the ICU
  3. Provider order for respiratory monitoring using continuous capnography
  4. Receiving intrathecal or epidural opioids
  5. Trauma patient with a nerve block
  6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor
  7. History or diagnosis of a sleep disordered breathing syndrome
  8. Use of CPAP or BIPAP non-invasive ventilation as home regime
  9. Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition)
  10. Receiving non-invasive ventilation
  11. Unable or unwilling to participate
  12. Member of a vulnerable population such as pregnant women or prisoners
Contacts and Locations

Locations
Layout table for location information
United States, California
Community Regional Medical Center
Fresno, California, United States, 93621
Sponsors and Collaborators
Fresno Community Hospital and Medical Center
University of California, Los Angeles
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Susan J Dempsey, PhD(c) UCLA and Community Regional Medical Center
Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 14, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date July 29, 2019
Estimated Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
  • Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
    The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.
  • Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
    The percentage of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.
  • Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
    The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.
Original Primary Outcome Measures
 (submitted: May 10, 2019) 		Hypoventilation [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ]
Continuous respiratory monitoring using capnography will be performed for collecting data of end-tidal carbon dioxide (etCO2)
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2019)
  • Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
    The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.
  • Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
    The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.
  • Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
    The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.
Original Secondary Outcome Measures
 (submitted: May 10, 2019) 		Hypoxemia [ Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration ] ]
Continuous respiratory monitoring using pulse oximetry will be performed for collecting data of oxygen saturation (SpO2)
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2019)
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    The number of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    The percentage of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    The characteristics of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The number of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The percentage of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The characteristics of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The number of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The percentage of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    The characteristics of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study
Original Other Pre-specified Outcome Measures
 (submitted: May 10, 2019)
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ] ]
    Sedation assessment will be preformed using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represent normal sleep and increasing numbers represent increasing levels of Sedation and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    Sedation assessment will be preformed using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of Sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study
  • Sedation [ Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration ]
    Sedation assessment will be preformed using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of Sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study
 
Descriptive Information
Brief Title Incidence OIRD Medical and Trauma Patients
Official Title Incidence of OIRD in Medical and Trauma Patients on the General Care Floor Receiving PCA or Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study
Brief Summary The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target study population will be hospitalized, adult medical or trauma patients on the general care floor receiving patient-controlled analgesia or nurse administered intravenous opioids for acute pain.
Condition
  • Respiratory Depression
  • Sedation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Andersen LW, Berg KM, Chase M, Cocchi MN, Massaro J, Donnino MW; American Heart Association's Get With The Guidelines(®)-Resuscitation Investigators. Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors associated with in-hospital mortality. Resuscitation. 2016 Aug;105:123-9. doi: 10.1016/j.resuscitation.2016.05.014. Epub 2016 May 30.
  • Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57.
  • Belcher AW, Khanna AK, Leung S, Naylor AJ, Hutcherson MT, Nguyen BM, Makarova N, Sessler DI, Devereaux PJ, Saager L. Long-Acting Patient-Controlled Opioids Are Not Associated With More Postoperative Hypoxemia Than Short-Acting Patient-Controlled Opioids After Noncardiac Surgery: A Cohort Analysis. Anesth Analg. 2016 Dec;123(6):1471-1479.
  • Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
  • Canet J, Sabaté S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223.
  • Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. Epub 2004 May 28. Review.
  • Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
  • Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25. Review.
  • Dempsey, SF, Khanna, AK, Buhre, W, Saager, L, DiStefano, P, Weingarten, T., Dahan, A., Brazzi, L., Overdyk, F., McIntyre, R. Incidence of Respiratory Depression and Derivation of a Novel Opioid-Induced Respriatory Depression Risk Prediction Tool. Poster presentation. UCLA School of Nursing Research Day, May 14, 2019.
  • Gupta K, Prasad A, Nagappa M, Wong J, Abrahamyan L, Chung FF. Risk factors for opioid-induced respiratory depression and failure to rescue: a review. Curr Opin Anaesthesiol. 2018 Feb;31(1):110-119. doi: 10.1097/ACO.0000000000000541. Review.
  • Izrailtyan I, Qiu J, Overdyk FJ, Erslon M, Gan TJ. Risk factors for cardiopulmonary and respiratory arrest in medical and surgical hospital patients on opioid analgesics and sedatives. PLoS One. 2018 Mar 22;13(3):e0194553. doi: 10.1371/journal.pone.0194553. eCollection 2018.
  • Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.
  • Khanna, A, Buhre, W, Saager, L, DiStefano, P, Weingarten, R, Dahan, A, Brazzi, L, & Overdyk, R. Derivation and validation of a novel opioid-induced respiratory depression risk predication tool. Critical Care Medicine 47(1):36, 2019.
  • Khanna AK, Sessler DI, Sun Z, Naylor AJ, You J, Hesler BD, Kurz A, Devereaux PJ, Saager L. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Br J Anaesth. 2016 May;116(5):632-40. doi: 10.1093/bja/aew029.
  • Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013 Apr;33(4):383-91. doi: 10.1002/phar.1223.
  • Lam T, Nagappa M, Wong J, Singh M, Wong D, Chung F. Continuous Pulse Oximetry and Capnography Monitoring for Postoperative Respiratory Depression and Adverse Events: A Systematic Review and Meta-analysis. Anesth Analg. 2017 Dec;125(6):2019-2029. doi: 10.1213/ANE.0000000000002557. Review.
  • Lee LA, Caplan RA, Stephens LS, Posner KL, Terman GW, Voepel-Lewis T, Domino KB. Postoperative opioid-induced respiratory depression: a closed claims analysis. Anesthesiology. 2015 Mar;122(3):659-65. doi: 10.1097/ALN.0000000000000564.
  • Morrison LJ, Neumar RW, Zimmerman JL, Link MS, Newby LK, McMullan PW Jr, Hoek TV, Halverson CC, Doering L, Peberdy MA, Edelson DP; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on P. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: a consensus statement from the American Heart Association. Circulation. 2013 Apr 9;127(14):1538-63. doi: 10.1161/CIR.0b013e31828b2770. Epub 2013 Mar 11.
  • Overdyk FJ, Dowling O, Marino J, Qiu J, Chien HL, Erslon M, Morrison N, Harrison B, Dahan A, Gan TJ. Association of Opioids and Sedatives with Increased Risk of In-Hospital Cardiopulmonary Arrest from an Administrative Database. PLoS One. 2016 Feb 25;11(2):e0150214. doi: 10.1371/journal.pone.0150214. eCollection 2016.
  • Perman SM, Stanton E, Soar J, Berg RA, Donnino MW, Mikkelsen ME, Edelson DP, Churpek MM, Yang L, Merchant RM; American Heart Association's Get With the Guidelines®-Resuscitation (formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Location of In-Hospital Cardiac Arrest in the United States-Variability in Event Rate and Outcomes. J Am Heart Assoc. 2016 Sep 29;5(10). pii: e003638.
  • Ronen M, Weissbrod R, Overdyk FJ, Ajizian S. Smart respiratory monitoring: clinical development and validation of the IPI™ (Integrated Pulmonary Index) algorithm. J Clin Monit Comput. 2017 Apr;31(2):435-442. doi: 10.1007/s10877-016-9851-7. Epub 2016 Mar 9.
  • Stites M, Surprise J, McNiel J, Northrop D, De Ruyter M. Continuous Capnography Reduces the Incidence of Opioid-Induced Respiratory Rescue by Hospital Rapid Resuscitation Team. J Patient Saf. 2017 Jul 20. doi: 10.1097/PTS.0000000000000408. [Epub ahead of print]
  • Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-15. doi: 10.1213/ANE.0000000000000836.
  • Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b. Erratum in: Anesthesiology. 2019 Dec 13;:null.
  • Safe use of opioids in hospitals. Sentinel Event Alert. 2012 Aug 8;(49):1-5.
  • Weingarten TN, Herasevich V, McGlinch MC, Beatty NC, Christensen ED, Hannifan SK, Koenig AE, Klanke J, Zhu X, Gali B, Schroeder DR, Sprung J. Predictors of Delayed Postoperative Respiratory Depression Assessed from Naloxone Administration. Anesth Analg. 2015 Aug;121(2):422-9. doi: 10.1213/ANE.0000000000000792.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 10, 2019) 		101
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 29, 2019
Estimated Primary Completion Date October 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Spontaneously breathing adults 18 to 89 years of age
  2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
  3. Admitted to the general care floor from the emergency department
  4. Able to provide written informed consent

Exclusion Criteria:

  1. Age is less than 18 years or greater than 89 years
  2. Transfer to the general care floor from the ICU
  3. Provider order for respiratory monitoring using continuous capnography
  4. Receiving intrathecal or epidural opioids
  5. Trauma patient with a nerve block
  6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor
  7. History or diagnosis of a sleep disordered breathing syndrome
  8. Use of CPAP or BIPAP non-invasive ventilation as home regime
  9. Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition)
  10. Receiving non-invasive ventilation
  11. Unable or unwilling to participate
  12. Member of a vulnerable population such as pregnant women or prisoners
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948880
Other Study ID Numbers FresnoCHMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Susan Dempsey Ortega, Fresno Community Hospital and Medical Center
Study Sponsor Fresno Community Hospital and Medical Center
Collaborators
  • University of California, Los Angeles
  • Medtronic
Investigators
Principal Investigator: Susan J Dempsey, PhD(c) UCLA and Community Regional Medical Center
PRS Account Fresno Community Hospital and Medical Center
Verification Date July 2019

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