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

Acute Respiratory Failure Clinical Trial

— SOHO  

Official title:

Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04468126
• Other study ID #: SOHO
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

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