Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Acute Respiratory Failure With Hypoxia Device: non invasive ventilation and high flow nasal canulae oxygen therapy

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure
Actual Study Start Date : February 22, 2016
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : February 19, 2018


Group/Cohort Intervention/treatment
NIV/HFNC
patients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy
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

HFNC/NIV
patients receiving high flow nasal canulae oxygen therapy than non-invasive ventilation
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Sampling Method:   Probability Sample
Study Population
Adults referred in ICU
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664322


Sponsors and Collaborators
University Hospital, Rouen
Investigators
Layout table for investigator information
Study Director: Christophe GIRAULT, MD Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France
Layout table for additonal information
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04664322    
Other Study ID Numbers: 2015-A00122-47
CPP-CS 001/2015 ( Other Identifier: CPP Nord Ouest 1 )
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD
Supporting Materials: Study Protocol
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Rouen:
alveolar recruitment
electrical impedance tomography
non-invasive ventilation
high-flow nasal cannula oxygen therapy
hypoxemic acute respiratory failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiratory Distress Syndrome
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Lung Diseases