An interventional study of high flow nasal cannula and standard oxygen in Respiratory Distress Syndrome, Adult, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 234 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Respiratory failure due to:
Other: standard oxygen
Device: high flow nasal cannula
humidified and heated oxygen
oxygen delivery through Venturi mask
Early deterioration
occurrence of any of the following from randomization: respiratory worsening; respiratory acidosis; severe respiratory distress; start of non-invasive ventilation; necessity of endotracheal intubation; development of shock; death.
Time frame: 24 hours
Development of respiratory acidosis
arterial pH
Time frame: 2, 12 and 24 hours
Development of hypercapnia
arterial pCO2
Time frame: 2, 12 and 24 hours
Worsening hypoxemia
P/F ratio
Time frame: 2, 12 and 24 hours
Worsening respiratory distress
respiratory frequency
Time frame: 2, 12 and 24 hours
duration of any type of ventilatory support
hours of ventilatory support
Time frame: 90 days
rate of ICU admission
number of patients admitted to ICU
Time frame: 90 days
hospital length-of-stay
duration of hospitalization
Time frame: 30 days
in-hospital mortality
death during hospitalization
Time frame: 90 days
ICU length-of-stay
duration of ICU stay
Time frame: 90 days
ICU mortality
death in ICU
Time frame: 90 days
development of complications
composite outcome of septic shock, nosocomial pneumonia, cardiac arrhythmia, cardiac arrest, delirium
Time frame: 90 days
level of dyspnea
utilizing Borg scale
Time frame: 24 hours
patient comfort
utilizing visual analogue scale
Time frame: 24 hours
clinical setting after ED stabilization
type of ward admission
Time frame: 24 hours
standard vs asymmetrical high-flow nasal cannula
rate of early deterioration in the treatment group will be compared between patients treated with standard or asymmetrical high-flow nasal cannula
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Fondazione Policlinico Universitario Agostino Gemelli IRCCS