An interventional study of High Flow Oxygen Therapy (HFOT) in Respiratory Failure and Hypercapnic Acidosis, sponsored by Cardarelli Hospital. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Cardarelli Hospital · Not applicable, Interventional, and Treatment
A reduction of peripheral oxygen saturation (SpO2) commonly occurs during bronchoscopy and may be associated with both respiratory and cardiac adverse events. The type of breathing assistance that should be delivered to patients, in order to treat and/or to prevent acute respiratory failure, during or after bronchoscopy, is not universally standardized; studies comparing the impact of different respiratory supports on patient's outcome and on hospital resource use are very few. the risk of respiratory failure rises according to the type of procedure (i.e., increased risk with broncho-alveolar lavage and trans-bronchial lung biopsy) and to the use of sedative drugs. Conventional oxygen therapy with nasal cannula, continuous positive airway pressure and non-invasive ventilation are commonly applied during endoscopic procedures. High flow oxygen therapy (HFOT) is a relatively novel device, still under-used in the context of interventional pulmonology, providing an humidified air-oxygen blend up to 60 L/min. HFOT has been reported to be effective for the treatment of both hypoxemic and hypercapnic respiratory failure. The investigators hypothesize that HFOT could be feasible and safe in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Cardarelli Hospital is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: High Flow Oxygen Therapy (HFOT)
HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
Number of desaturation, defined as SpO2< 90 percent percent for >1 min, <5.
Time frame: one year
Percent of variation of pH, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Time frame: one year
Percent of variation of PaCO2 variation, comparing ABG performed before bronchoscopy with that performed before partecipant's transferral to recovery room.
Time frame: one year
Rate of interruption of bronchoscopy because of number of desaturation, defined as SpO2< 90 percent for >1 min, >5.
Time frame: one year
Number of partecipants requiring an escalation of respiratory support.
Time frame: one year
Rate of new appearance of hemodynamic instability.
Time frame: one year
value of Charlson Comobidity Index associated with HFOT failure.
Time frame: one year
value of Body Mass Index associated with HFOT failure.
Time frame: one year
value of Borg dyspnea scale associated with HFOT failure.
Time frame: one year
Number of desaturations, defined as SpO2< 90 percent for >1 min.
Time frame: one year
Lowest oxygen saturation under HFOT.
Time frame: one year
Rate of change of HFOT parameters because of desaturation without respiratory acidosis.
Time frame: one year
Rate of change of HFOT parameters because of desaturation with respiratory acidosis
Time frame: one year
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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