CHu Poitiers
Poitiers, 86000, France
NCT Number: NCT04468126
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Poitiers, 86000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.
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%
Time frame: Day 28
Death between randomization and 28 days after randomization
Time frame: Day 28
Intubation between randomization and D28
Time frame: Day 90
Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.
Time frame: Day 28
days alive and without intubation between day 1 and day 28
Time frame: Day 90
ICU and hospital stay between randomisation and end of stay in ICU and hospital
Time frame: Day 90
Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.
Time frame: Hour 1
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)
Time frame: Hour [1;6]
comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"
Time frame: Hour [1;6]
Oxygenation is assessed by arterial blood gas sample
Time frame: Day 28
Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.
Time frame: Day 28
interval between the time when prespecified criteria of intubation are met and intubation
Time frame: Day 28
Interval between treatment initiation and intubation
Poitiers University Hospital
Other
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.
Acronym: SOHO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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