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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04664322
Other study ID # 2015-A00122-47
Secondary ID CPP-CS 001/2015
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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