Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure

Not Applicable

Recruiting

• Conditions: Hypoxemic Respiratory Failure; Acute Respiratory Failure
• Interventions: Other: Standard oxygen; Other: High-flow nasal oxygen therapy

• Registration Number: NCT04468126
• Lead Sponsor: Poitiers University Hospital

Brief Summary

First-line therapy of patients with acute respiratory failure consists in oxygen delivery through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not recommended. In a large randomized controlled study, high-flow nasal oxygen has been described as superior to non-invasive ventilation and standard oxygen in terms of mortality but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen has not been shown to be superior to standard oxygen. To improve the level of evidence of daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen, in terms of mortality in all patients with acute hypoxemic respiratory failure

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2021-01-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2024-10-17
• Study Completion: 2024-12-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1110

Inclusion Criteria

All consecutive patients older than 18 years with an acute hypoxemic respiratory failure will be enrolled if they meet all the following criteria:

• Respiratory rate >25 breaths/min whatever the oxygen support
• Pulmonary infiltrate,
• PaO2/FiO2 ≤200 mmHg
• Informed consent from the patient or relatives.

Exclusion Criteria

• PaCO2 > 45 mm Hg
• Need for emergent intubation: pulse oximetry < 90% with maximum oxygen support, respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points
• Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors > 0.3 µg/kg/min
• Glasgow coma scale equal to or below 12 points
• Exacerbation of chronic lung disease including chronic obstructive pulmonary disease (grade 3 or 4 of Gold classification), or another chronic lung disease with long term oxygen or ventilatory support
• Cardiogenic pulmonary edema as main reason for acute respiratory failure
• Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID study has been completed)
• Post-extubation respiratory failure within 7 days after extubation,
• Post-operative patients within 7 days after abdominal or cardiothoracic surgery,
• Do not intubate order;
• Already included in the study, refusal to participate or participation in another interventional study with the same primary outcome.
• Patients without any healthcare insurance scheme or not benefiting from it through a third party,
• Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard oxygen group	Standard oxygen	In order to maintain SpO2 between 92 and 96%
high-flow nasal cannula oxygen group	High-flow nasal oxygen therapy	At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %

Primary Outcome Measures

Name	Time	Method
Mortality at 28 days after randomization	Day 28	Death between randomization and 28 days after randomization

Secondary Outcome Measures

Name	Time	Method
Failure of the oxygenation strategy between randomization and D28	Day 28	Intubation between randomization and D28
Complications during the ICU stay	Day 90	Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.
Comfort	Hour 6	comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"
Number of ventilation free days at Day 28	Day 28	days alive and without intubation between day 1 and day 28
Dyspnea	Hour 6	feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)
Duration between treatment initiation and intubation	Day 28	Interval between treatment initiation and intubation
Level of oxygenation	Hour 48	Oxygenation is assessed by arterial blood gas sample
Duration between the time when prespecified criteria of intubation are met and intubation	Day 28	interval between the time when prespecified criteria of intubation are met and intubation
Mortality in ICU, in hospital, and day 90	Day 90	Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.
Duration of ICU and hospital stay	Day 90	ICU and hospital stay between randomisation and end of stay in ICU and hospital
Organ Failure during the 48 hours after intubation.	Day 28	Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.

Trial Locations

Locations (1)

CHu Poitiers; 🇫🇷 Poitiers, France