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

• ClinicalTrials.gov Identifier: NCT04664322
• Recruitment Status: Completed
• First Posted: December 11, 2020
• Last Update Posted: December 11, 2020
• Sponsor: University Hospital, Rouen
• 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

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

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