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出境医 / 临床实验 / Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo (IVOXY)

Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo (IVOXY)

Study Description
Brief Summary:

De novo acute hypoxemic respiratory failure (AHRF) is associated with high overall mortality, which increases significantly with the use of orotracheal intubation. High flow nasal canula (HFNC) has turned to be the first line non-invasive oxygenation strategy aiming to avoid intubation. One of the main factors worsening lung injury and increasing mortality in invasively ventilated patients is a too high tidal volume (TV) delivered by the ventilator. Consistent data suggest that such an aggravation of respiratory lesions may occur during spontaneous ventilation if TV is too large. This phenomenon is called Patient self-inflicted lung injury (P-SILI). The effect of TV on the outcome of patients with de novo AHRF under HFNC has never been evaluated since TV is not easily accessible in patients under HFNC. Investigators hypothesized that a large TV during HFNC has an impact on the outcome. TV will be measured using chest Electrical Impedance Tomography (EIT). To calibrate the EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. Thus, EIT signal can be used to calculate TV during HFNC since it remains reliable even when the positive expiratory pressure changes.

A secondary objective is to quantify a respiratory distress index. This quantification will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle Investigators want to be able to evaluate up to 6 predictors of HFNC failure in this research with an effect size of 0.15, α risk of 0.05, and a power of 0.8. A number of 55 participants is required. Investigators plan to include 60 patients due to potential withdrawal of consent and/or unusable data.


Condition or disease Intervention/treatment Phase
Acute Hypoxemic Respiratory Failure Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC) Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Tidal volume (TV) during high flow nasal canula (HFNC) will be measured using chest Electrical Impedance Tomography (EIT). To calibrate EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. The quantification of respiratory distress index will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 3, 2021
Estimated Study Completion Date : September 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental
Every adult patient admitted to the medical intensive care unit for de novo acute hypoxemic respiratory failure, and placed under hign flow nasal canula (HFNC). Inclusion and exclusion criterion are listed elsewhere.
 Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
After information and consent, patients under HFNC for de novo acute hypoxemic respiratory failure will undergo a ten minutes 4cmH2O continuous positive airway pressure(CPAP) test while monitored with 1)chest Electrical Impedance Tomography (EIT) 2) a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece and connected to a differential pressure sensor, and 3) respiratory inductance plethysmography (RIP). Airway flow signal will be acquired using an analog/digital converter and stored for further analysis with acknowledge software. This will allow converting EIT data into tidal volume (TV), and estimating TV under HFNC. RIP signals will allow evaluating asynchronism between chest and abdomen by calculating the phase angle, thus quantifying respiratory distress. Patients monitored with an arterial catheter, arterial blood gas measurements will be done during CPAP and HFNC. These measures will be collected the first day of HFNC, and everyday up to three days
Outcome Measures
Primary Outcome Measures :
  1. Failure of high flow nasal canula (HFNC) at day 28 [ Time Frame: Day 28 ]
    Failure of HFNC is defined as death or need for invasive mechanical ventilation


Secondary Outcome Measures :
  1. Tidal volume under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)

  2. Phase angle computed by respiratory inductance plethysmography (RIP) [ Time Frame: Day 0, Day 1 and Day 2 ]
    Phase angle will be measured by respiratory inductance plethysmography

  3. Respiratory rate [ Time Frame: Day 0, Day 1 and Day 2 ]
    respiratory rate will be measured at each evaluation

  4. pH under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    pH will be measured via Blood gases

  5. PaO2 under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    PaO2 will be measured via Blood gases

  6. PaCO2 under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    PaCO2 will be measured via Blood gases

  7. SaO2 under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    SaO2 will be measured via Blood gases

  8. Regional tidal volume. [ Time Frame: Day 0, Day 1 and Day 2 ]
    computed by Electrical Impedance Tomography

  9. Mortality [ Time Frame: Day 28, Day90 ]
    Mortality at Day 28, Day 90


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • HFNC initiated as part of the care
  • Respiratory rate > 25 / minute
  • PaO2/FiO2 ratio < 300 mm Hg
  • PaCO2 < 45 mm Hg
  • Affiliated with a social security system
  • Informed consent signed by the patient, trusted person or family member if the patient is unable to consent

Exclusion Criteria:

  • Acute cardiogenic pulmonary edema
  • Underlying chronic respiratory disease
  • Asthma exacerbation
  • Chronic obstructive pulmonary disease Exacerbation
  • Hemodynamic instability, defined as systolic arterial blood pressure < 90 mm Hg or mean arterial blood pressure < 65 mm Hg or the use of vasopressors
  • Glasgow Coma Score <= 12
  • Contraindication to CPAP (maxillofacial surgery, facial trauma)
  • Refusal of the patient to perform the CPAP test
  • Need for emergency intubation according to the clinician in charge of the patient
  • Patient protected by law
  • Pregnancy or breastfeeding woman
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Guillaume CARTEAUX, Doctor +331 49 81 43 85 Guillaume.carteaux@aphp.fr

Locations
Layout table for location information
France
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Créteil, France, 94010
Contact: Guillaume CARTEAUX, Doctor    +331 49 81 43 85    Guillaume.carteaux@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Guillaume CARTEAUX, Doctor Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date May 16, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Failure of high flow nasal canula (HFNC) at day 28 [ Time Frame: Day 28 ]
Failure of HFNC is defined as death or need for invasive mechanical ventilation
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019) 		Failure of HFNC at day 28 [ Time Frame: Day 28 ]
Failure of HFNC is defined as death or need for invasive mechanical ventilation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Tidal volume under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)
  • Phase angle computed by respiratory inductance plethysmography (RIP) [ Time Frame: Day 0, Day 1 and Day 2 ]
    Phase angle will be measured by respiratory inductance plethysmography
  • Respiratory rate [ Time Frame: Day 0, Day 1 and Day 2 ]
    respiratory rate will be measured at each evaluation
  • pH under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    pH will be measured via Blood gases
  • PaO2 under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    PaO2 will be measured via Blood gases
  • PaCO2 under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    PaCO2 will be measured via Blood gases
  • SaO2 under high flow nasal canula (HFNC) [ Time Frame: Day 0, Day 1 and Day 2 ]
    SaO2 will be measured via Blood gases
  • Regional tidal volume. [ Time Frame: Day 0, Day 1 and Day 2 ]
    computed by Electrical Impedance Tomography
  • Mortality [ Time Frame: Day 28, Day90 ]
    Mortality at Day 28, Day 90
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Tidal volume under HFNC [ Time Frame: Day 0, Day 1 and Day 2 ]
    Tidal volume will be measured using chest Electrical Impedance Tomography (EIT)
  • Phase angle computed by RIP [ Time Frame: Day 0, Day 1 and Day 2 ]
    Phase angle will be measured by respiratory inductance plethysmography
  • Respiratory rate [ Time Frame: Day 0, Day 1 and Day 2 ]
    respiratory rate will be measured at each evaluation
  • pH under HFNC [ Time Frame: Day 0, Day 1 and Day 2 ]
    pH will be measured via Blood gases
  • PaO2 under HFNC [ Time Frame: Day 0, Day 1 and Day 2 ]
    PaO2 will be measured via Blood gases
  • PaCO2 under HFNC [ Time Frame: Day 0, Day 1 and Day 2 ]
    PaCO2 will be measured via Blood gases
  • SaO2 under HFNC [ Time Frame: Day 0, Day 1 and Day 2 ]
    SaO2 will be measured via Blood gases
  • Regional tidal volume. [ Time Frame: Day 0, Day 1 and Day 2 ]
    computed by Electrical Impedance Tomography
  • Mortality [ Time Frame: Day 28, Day90 ]
    Mortality at Day 28, Day 90
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
Official Title  ICMJE Impact of Current Volume Under High-rate Nasal Oxygen Therapy During Acute Hypoxemic Respiratory Failure de Novo
Brief Summary

De novo acute hypoxemic respiratory failure (AHRF) is associated with high overall mortality, which increases significantly with the use of orotracheal intubation. High flow nasal canula (HFNC) has turned to be the first line non-invasive oxygenation strategy aiming to avoid intubation. One of the main factors worsening lung injury and increasing mortality in invasively ventilated patients is a too high tidal volume (TV) delivered by the ventilator. Consistent data suggest that such an aggravation of respiratory lesions may occur during spontaneous ventilation if TV is too large. This phenomenon is called Patient self-inflicted lung injury (P-SILI). The effect of TV on the outcome of patients with de novo AHRF under HFNC has never been evaluated since TV is not easily accessible in patients under HFNC. Investigators hypothesized that a large TV during HFNC has an impact on the outcome. TV will be measured using chest Electrical Impedance Tomography (EIT). To calibrate the EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. Thus, EIT signal can be used to calculate TV during HFNC since it remains reliable even when the positive expiratory pressure changes.

A secondary objective is to quantify a respiratory distress index. This quantification will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle Investigators want to be able to evaluate up to 6 predictors of HFNC failure in this research with an effect size of 0.15, α risk of 0.05, and a power of 0.8. A number of 55 participants is required. Investigators plan to include 60 patients due to potential withdrawal of consent and/or unusable data.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Tidal volume (TV) during high flow nasal canula (HFNC) will be measured using chest Electrical Impedance Tomography (EIT). To calibrate EIT data, i.e. to be able to convert changes in thoracic impedance into TV, thoracic impedance signal, flow and volume will be collected during a 4 cmH2O continuous positive airway pressure (CPAP) test, using a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece. Such a level of CPAP is supposed to reproduce the majority of the physiological effects of HFNC. The quantification of respiratory distress index will be recorded by respiratory inductance plethysmography (RIP), obtained using two elastic bands equipped with a sensor sensitive to their stretching, one positioned at the level of the thorax, the other at the level of the abdomen. The stretching changes of the two bands during the respiratory cycle allow evaluating their possible asynchronism by calculating the phase angle.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Acute Hypoxemic Respiratory Failure
Intervention  ICMJE Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
After information and consent, patients under HFNC for de novo acute hypoxemic respiratory failure will undergo a ten minutes 4cmH2O continuous positive airway pressure(CPAP) test while monitored with 1)chest Electrical Impedance Tomography (EIT) 2) a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece and connected to a differential pressure sensor, and 3) respiratory inductance plethysmography (RIP). Airway flow signal will be acquired using an analog/digital converter and stored for further analysis with acknowledge software. This will allow converting EIT data into tidal volume (TV), and estimating TV under HFNC. RIP signals will allow evaluating asynchronism between chest and abdomen by calculating the phase angle, thus quantifying respiratory distress. Patients monitored with an arterial catheter, arterial blood gas measurements will be done during CPAP and HFNC. These measures will be collected the first day of HFNC, and everyday up to three days
Study Arms  ICMJE Experimental: Experimental
Every adult patient admitted to the medical intensive care unit for de novo acute hypoxemic respiratory failure, and placed under hign flow nasal canula (HFNC). Inclusion and exclusion criterion are listed elsewhere.
Intervention: Diagnostic Test: Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)
Publications *
  • Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, Gasparetto A, Meduri GU. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998 Aug 13;339(7):429-35.
  • Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez-Diaz G, Confalonieri M, Pelaia P, Principi T, Gregoretti C, Beltrame F, Pennisi MA, Arcangeli A, Proietti R, Passariello M, Meduri GU. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med. 2001 Nov;27(11):1718-28. Epub 2001 Oct 16.
  • Confalonieri M, Potena A, Carbone G, Porta RD, Tolley EA, Umberto Meduri G. Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91.
  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
  • Carteaux G, Millán-Guilarte T, De Prost N, Razazi K, Abid S, Thille AW, Schortgen F, Brochard L, Brun-Buisson C, Mekontso Dessap A. Failure of Noninvasive Ventilation for De Novo Acute Hypoxemic Respiratory Failure: Role of Tidal Volume. Crit Care Med. 2016 Feb;44(2):282-90. doi: 10.1097/CCM.0000000000001379.
  • Frat JP, Ragot S, Coudroy R, Constantin JM, Girault C, Prat G, Boulain T, Demoule A, Ricard JD, Razazi K, Lascarrou JB, Devaquet J, Mira JP, Argaud L, Chakarian JC, Fartoukh M, Nseir S, Mercat A, Brochard L, Robert R, Thille AW; REVA network. Predictors of Intubation in Patients With Acute Hypoxemic Respiratory Failure Treated With a Noninvasive Oxygenation Strategy. Crit Care Med. 2018 Feb;46(2):208-215. doi: 10.1097/CCM.0000000000002818.
  • Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP.
  • Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.
  • Mauri T, Eronia N, Turrini C, Battistini M, Grasselli G, Rona R, Volta CA, Bellani G, Pesenti A. Bedside assessment of the effects of positive end-expiratory pressure on lung inflation and recruitment by the helium dilution technique and electrical impedance tomography. Intensive Care Med. 2016 Oct;42(10):1576-1587. doi: 10.1007/s00134-016-4467-4. Epub 2016 Aug 12.
  • Hammer J, Newth CJ. Assessment of thoraco-abdominal asynchrony. Paediatr Respir Rev. 2009 Jun;10(2):75-80. doi: 10.1016/j.prrv.2009.02.004. Epub 2009 Apr 9. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years old
  • HFNC initiated as part of the care
  • Respiratory rate > 25 / minute
  • PaO2/FiO2 ratio < 300 mm Hg
  • PaCO2 < 45 mm Hg
  • Affiliated with a social security system
  • Informed consent signed by the patient, trusted person or family member if the patient is unable to consent

Exclusion Criteria:

  • Acute cardiogenic pulmonary edema
  • Underlying chronic respiratory disease
  • Asthma exacerbation
  • Chronic obstructive pulmonary disease Exacerbation
  • Hemodynamic instability, defined as systolic arterial blood pressure < 90 mm Hg or mean arterial blood pressure < 65 mm Hg or the use of vasopressors
  • Glasgow Coma Score <= 12
  • Contraindication to CPAP (maxillofacial surgery, facial trauma)
  • Refusal of the patient to perform the CPAP test
  • Need for emergency intubation according to the clinician in charge of the patient
  • Patient protected by law
  • Pregnancy or breastfeeding woman
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guillaume CARTEAUX, Doctor +331 49 81 43 85 Guillaume.carteaux@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919331
Other Study ID Numbers  ICMJE APHP180138
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  ICMJE
Plan to Share IPD: No
Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guillaume CARTEAUX, Doctor Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - Créteil
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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