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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04468126
Other study ID # SOHO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 19, 2021
Est. completion date December 18, 2024

Study information

Verified date November 2023
Source Poitiers University Hospital
Contact Jean-Pierre FRAT, PhD
Phone 05 49 44 60 64
Email jean-pierre.frat@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 1110
Est. completion date December 18, 2024
Est. primary completion date October 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Standard oxygen
Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.
High-flow nasal oxygen therapy
Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%

Locations

Country Name City State
France CHu Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

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