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

NCT04664322 | Completed

• 2 other identifiers: 2015-A00122-47CPP-CS 001/2015
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Failure With Hypoxia

Keywords

alveolar recruitment; electrical impedance tomography; non-invasive ventilation; high-flow nasal cannula oxygen therapy; hypoxemic acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ROI EELI

  after 5 minutes of stable breathing with the oxygenation technic

• global TV

  after 5 minutes of stable breathing with the oxygenation technic

• ROI TV

  after 5 minutes of stable breathing with the oxygenation technic

Study Arms (2)

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

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

Interventions

non invasive ventilation and high flow nasal canulae oxygen therapy DEVICE

patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy

HFNC/NIV; NIV/HFNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults referred in ICU

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Christophe GIRAULT, MD

  Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 11, 2020
• Study Start: February 22, 2016
• Primary Completion: February 13, 2018
• Study Completion: February 19, 2018
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: from the first patient enrollment ( 02/22/2016) to publication
• Access Criteria: Excel database was shared with biostatisticians for statistical analysis