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出境医 / 临床实验 / Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery (OPTIPRONE)

Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery (OPTIPRONE)

Study Description
Brief Summary:

Background:

There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position.

Hypothesis:

In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position.

Aims:

To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery.

To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure.

Methods:

Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.


Condition or disease Intervention/treatment
Anesthesia Surgery Other: Evaluation of PEEP in prone position

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Positive End-Expiratory Pressure (PEEP) [ Time Frame: 10 minutes after intubation ]
    Positive End-Expiratory Pressure (cmH2O) in supine position

  2. Positive End-Expiratory Pressure (PEEP) [ Time Frame: 10 minutes after positioning ]
    Positive End-Expiratory Pressure (cmH2O) in prone position

  3. Change in Positive End-Expiratory Pressure (PEEP) [ Time Frame: From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of Positive End-Expiratory Pressure (cmH2O) during surgery in prone position with respect to PEEP value at 10 minutes after positioning


Secondary Outcome Measures :
  1. Static compliance [ Time Frame: 10 minutes after intubation ]
    Tidal volume / Plateau pressure ratio (mL/cmH2O) in supine position

  2. Static compliance [ Time Frame: 10 minutes after positioning ]
    Tidal volume / Plateau pressure ratio (mL/cmH2O) in prone position

  3. Change in static compliance [ Time Frame: Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of static compliance (Tidal volume / Plateau pressure ratio, in mL/cmH2O) during surgery in prone position

  4. Arterial oxygen pressure (PaO2) [ Time Frame: 10 minutes after intubation ]
    Partial pressure of oxygen (mmHg) in supine position

  5. Arterial oxygen pressure (PaO2) [ Time Frame: 10 minutes after positioning ]
    Partial pressure of oxygen (mmHg) in prone position

  6. Change in arterial oxygen pressure (PaO2) [ Time Frame: Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of partial pressure of oxygen (mmHg) during surgery in prone position

  7. Arterial carbon dioxide pressure (PaCO2) [ Time Frame: 10 minutes after intubation ]
    Partial pressure of carbon dioxide (mmHg) in supine position

  8. Arterial carbon dioxide pressure (PaCO2) [ Time Frame: 10 minutes after positioning ]
    Partial pressure of carbon dioxide (mmHg) in prone position

  9. Change in arterial carbon dioxide pressure (PaCO2) [ Time Frame: Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of partial pressure of carbon dioxide (mmHg) during surgery in prone position


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 27, 2019
First Posted Date July 18, 2019
Last Update Posted Date July 24, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • Positive End-Expiratory Pressure (PEEP) [ Time Frame: 10 minutes after intubation ]
    Positive End-Expiratory Pressure (cmH2O) in supine position
  • Positive End-Expiratory Pressure (PEEP) [ Time Frame: 10 minutes after positioning ]
    Positive End-Expiratory Pressure (cmH2O) in prone position
  • Change in Positive End-Expiratory Pressure (PEEP) [ Time Frame: From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of Positive End-Expiratory Pressure (cmH2O) during surgery in prone position with respect to PEEP value at 10 minutes after positioning
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • Static compliance [ Time Frame: 10 minutes after intubation ]
    Tidal volume / Plateau pressure ratio (mL/cmH2O) in supine position
  • Static compliance [ Time Frame: 10 minutes after positioning ]
    Tidal volume / Plateau pressure ratio (mL/cmH2O) in prone position
  • Change in static compliance [ Time Frame: Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of static compliance (Tidal volume / Plateau pressure ratio, in mL/cmH2O) during surgery in prone position
  • Arterial oxygen pressure (PaO2) [ Time Frame: 10 minutes after intubation ]
    Partial pressure of oxygen (mmHg) in supine position
  • Arterial oxygen pressure (PaO2) [ Time Frame: 10 minutes after positioning ]
    Partial pressure of oxygen (mmHg) in prone position
  • Change in arterial oxygen pressure (PaO2) [ Time Frame: Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of partial pressure of oxygen (mmHg) during surgery in prone position
  • Arterial carbon dioxide pressure (PaCO2) [ Time Frame: 10 minutes after intubation ]
    Partial pressure of carbon dioxide (mmHg) in supine position
  • Arterial carbon dioxide pressure (PaCO2) [ Time Frame: 10 minutes after positioning ]
    Partial pressure of carbon dioxide (mmHg) in prone position
  • Change in arterial carbon dioxide pressure (PaCO2) [ Time Frame: Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours) ]
    Variation of partial pressure of carbon dioxide (mmHg) during surgery in prone position
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery
Official Title Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study
Brief Summary

Background:

There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position.

Hypothesis:

In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position.

Aims:

To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery.

To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure.

Methods:

Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.

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 Patients scheduled for spine surgery that requires prone decubitus.
Condition
  • Anesthesia
  • Surgery
Intervention Other: Evaluation of PEEP in prone position
Assessment of optimal Positive End-Expiratory Pressure (PEEP) in patients undergoing scheduled spine surgery in prone position.
Study Groups/Cohorts Not Provided
Publications *
  • Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. Review. Erratum in: N Engl J Med. 2014 Apr 24;370(17):1668-9.
  • 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.
  • Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
  • Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. Review.
  • Goldenberg NM, Steinberg BE, Lee WL, Wijeysundera DN, Kavanagh BP. Lung-protective ventilation in the operating room: time to implement? Anesthesiology. 2014 Jul;121(1):184-8. doi: 10.1097/ALN.0000000000000274.
  • Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
  • Coppola S, Froio S, Chiumello D. Protective lung ventilation during general anesthesia: is there any evidence? Crit Care. 2014 Mar 18;18(2):210. doi: 10.1186/cc13777. Review.
  • Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.
  • Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.
  • Hemmes SN, Severgnini P, Jaber S, Canet J, Wrigge H, Hiesmayr M, Tschernko EM, Hollmann MW, Binnekade JM, Hedenstierna G, Putensen C, de Abreu MG, Pelosi P, Schultz MJ. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery. Trials. 2011 May 6;12:111. doi: 10.1186/1745-6215-12-111.
  • Gattinoni L, Caironi P. Prone positioning: beyond physiology. Anesthesiology. 2010 Dec;113(6):1262-4. doi: 10.1097/ALN.0b013e3181fcd97e.
  • Pelosi P, Caironi P, Taccone P, Brazzi L. Pathophysiology of prone positioning in the healthy lung and in ALI/ARDS. Minerva Anestesiol. 2001 Apr;67(4):238-47. Review.
  • Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380. Review.
  • Mure M, Domino KB, Lindahl SG, Hlastala MP, Altemeier WA, Glenny RW. Regional ventilation-perfusion distribution is more uniform in the prone position. J Appl Physiol (1985). 2000 Mar;88(3):1076-83.
  • Pelosi P, Croci M, Calappi E, Cerisara M, Mulazzi D, Vicardi P, Gattinoni L. The prone positioning during general anesthesia minimally affects respiratory mechanics while improving functional residual capacity and increasing oxygen tension. Anesth Analg. 1995 May;80(5):955-60.
  • Pelosi P, Croci M, Calappi E, Mulazzi D, Cerisara M, Vercesi P, Vicardi P, Gattinoni L. Prone positioning improves pulmonary function in obese patients during general anesthesia. Anesth Analg. 1996 Sep;83(3):578-83.
  • Petersson J, Ax M, Frey J, Sánchez-Crespo A, Lindahl SG, Mure M. Positive end-expiratory pressure redistributes regional blood flow and ventilation differently in supine and prone humans. Anesthesiology. 2010 Dec;113(6):1361-9. doi: 10.1097/ALN.0b013e3181fcec4f.
  • Beitler JR, Guérin C, Ayzac L, Mancebo J, Bates DM, Malhotra A, Talmor D. PEEP titration during prone positioning for acute respiratory distress syndrome. Crit Care. 2015 Dec 21;19:436. doi: 10.1186/s13054-015-1153-9.
  • Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST. Erratum in: Am J Respir Crit Care Med. 2017 Jun 1;195(11):1540.
  • Spaeth J, Daume K, Goebel U, Wirth S, Schumann S. Increasing positive end-expiratory pressure (re-)improves intraoperative respiratory mechanics and lung ventilation after prone positioning. Br J Anaesth. 2016 Jun;116(6):838-46. doi: 10.1093/bja/aew115.
  • Katoh T, Suguro Y, Ikeda T, Kazama T, Ikeda K. Influence of age on awakening concentrations of sevoflurane and isoflurane. Anesth Analg. 1993 Feb;76(2):348-52.
  • Pelosi P, Gama de Abreu M, Rocco PR. New and conventional strategies for lung recruitment in acute respiratory distress syndrome. Crit Care. 2010;14(2):210. doi: 10.1186/cc8851. Epub 2010 Mar 9. Review.
  • Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
  • Mahajan RP, Hennessy N, Aitkenhead AR, Jellinek D. Effect of three different surgical prone positions on lung volumes in healthy volunteers. Anaesthesia. 1994 Jul;49(7):583-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 16, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥18 years.
  • Spine prone surgery lasting ≥2 hours.
  • Absence of known pulmonary pathology.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Contraindication to alveolar recruitment maneuvers (risk of barotrauma, hemodynamic instability).
  • Body mass index (BMI) >35.
  • Heart failure defined as IC <2.5 L/min/m2 and/or inotropic support requirements prior to surgery.
  • Diagnosis or suspicion of intracranial hypertension (intracranial pressure >15 mmHg).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024410
Other Study ID Numbers 2018/8270/I
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 Parc de Salut Mar
Study Sponsor Parc de Salut Mar
Collaborators Not Provided
Investigators
Principal Investigator: Lluís Gallart, Dr Hospital del Mar (Barcelona, Spain)
PRS Account Parc de Salut Mar
Verification Date June 2019