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High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure (IRAvista)

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ClinicalTrials.gov Identifier: NCT04664322
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date November 19, 2020
First Posted Date December 11, 2020
Last Update Posted Date December 11, 2020
Actual Study Start Date February 22, 2016
Actual Primary Completion Date February 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2020)
global EELI [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]
measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 10, 2020)
  • ROI EELI [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]
    measurement of regional of interest (ROI) end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
  • global TV [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]
    measurement of global tidal variation (TV) with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
  • ROI TV [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]
    measurement of regional tidal variation with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
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 High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure
Official Title High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure
Brief Summary This physiological study showed an increase in regional ventilation with NIV but no difference in alveolar recruitment as compared to HFNC in patients with hypoxemic ARF. Although NIV provided better oxygenation than HFNC, the effect on lung volumes could explain the potentially deleterious effect of NIV in hypoxemic ARF, reinforcing the recently developed concept of patient self-inflicted lung injury.
Detailed Description Background: High-flow nasal cannula (HFNC) oxygen therapy has recently shown clinical benefits in hypoxemic acute respiratory failure (ARF) patients, while the interest of non-invasive ventilation (NIV) remains debated. The primary endpoint was to compare alveolar recruitment using global end-expiratory electrical lung impedance (EELI) between HFNC and NIV. Secondary endpoints compared regional EELI, lung volumes (global and regional tidal volume variation (TV)), respiratory parameters, hemodynamic tolerance, dyspnea and patient comfort between HFNC and NIV, relative to face mask (FM).
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults referred in ICU
Condition Acute Respiratory Failure With Hypoxia
Intervention Device: non invasive ventilation and high flow nasal canulae oxygen therapy
patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy
Study Groups/Cohorts
  • NIV/HFNC
    patients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy
    Intervention: Device: non invasive ventilation and high flow nasal canulae oxygen therapy
  • HFNC/NIV
    patients receiving high flow nasal canulae oxygen therapy than non-invasive ventilation
    Intervention: Device: non invasive ventilation and high flow nasal canulae oxygen therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 10, 2020)
16
Original Actual Enrollment Same as current
Actual Study Completion Date February 19, 2018
Actual Primary Completion Date February 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients referred in ICU
  • with hypoxemic acute respiratory failure due to a community acquired pneumonia confirmed by chest X ray,
  • with PaO2 < 60mmHg in ambient air, without hypercapnia (PaCO2 < 45 mmHg),
  • requiring more than 6L/min of O2 on admission with high concentration FM, and justifying HFNC or NIV for the attending ICU physician

Exclusion Criteria:

  • cardiogenic pulmonary oedema,
  • moderate to severe underlying respiratory disease including COPD (chronic obstructive pulmonary disease)
  • contraindication to or failure of previous NIV or HFNC with the need for immediate invasive ventilation
  • pregnant or breast-feeding women
  • carrier of an implantable defibrillator or pacemaker
  • body mass index (BMI)>50 kg/m2
  • with cutaneous lesion next to the positioning zone of the Pulmovista® (Dräger, Lübeck, Germany) belt
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04664322
Other Study ID Numbers 2015-A00122-47
CPP-CS 001/2015 ( Other Identifier: CPP Nord Ouest 1 )
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: Yes
Plan Description: all collected IPD
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: from the first patient enrollment ( 02/22/2016) to publication
Access Criteria: Excel database was shared with biostatisticians for statistical analysis
Current Responsible Party University Hospital, Rouen
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Rouen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Christophe GIRAULT, MD Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France
PRS Account University Hospital, Rouen
Verification Date December 2020