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

Acute Respiratory Failure With Hypoxia Clinical Trial

— IRAvista  

Official title:

High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664322
• Other study ID #: 2015-A00122-47
• Secondary ID: CPP-CS 001/2015
• Status: Completed
• Start date: February 22, 2016
• Est. completion date: February 19, 2018

Study information

• Verified date: December 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 19, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure With Hypoxia
• Hypoxia
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global EELI	measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit	after 5 minutes of stable breathing with the oxygenation technic
Secondary	ROI EELI	measurement of regional of interest (ROI) end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit	after 5 minutes of stable breathing with the oxygenation technic
Secondary	global TV	measurement of global tidal variation (TV) with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit	after 5 minutes of stable breathing with the oxygenation technic
Secondary	ROI TV	measurement of regional tidal variation with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit	after 5 minutes of stable breathing with the oxygenation technic