An interventional study of High flow nasal canula in Respiratory Failure and Respiratory Failure With Hypercapnia, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
This prospective interventional study aims to evaluate the safety and efficacy of high-flow nasal cannula (HFNC) oxygen therapy during fiber-optic bronchoscopy in patients with respiratory failure. The study will assess oxygenation, ventilation, , procedural interruptions, adverse events, patient comfort, and clinical outcomes during and after bronchoscopy.
Fiber-optic bronchoscopy is an important diagnostic and therapeutic procedure that may cause transient or clinically significant deterioration in oxygenation and ventilation, particularly in patients with respiratory failure. High-flow nasal cannula (HFNC) provides heated and humidified oxygen at high flow rates and may improve oxygenation and respiratory support during bronchoscopy.
This prospective, single-group, pre-post interventional study will evaluate the safety and efficacy of HFNC during fiber-optic bronchoscopy in patients with respiratory failure. Eligible patients undergoing fiber-optic bronchoscopy will receive HFNC before, during, and after the procedure. HFNC will be initiated approximately 10 minutes before bronchoscopy and maintained throughout the procedure and for 1-2 hours after the procedure.
HFNC will be delivered using a Vapotherm Precision Flow Hi-VNI system. The initial flow rate will be 40 L/min, with adjustment as clinically appropriate. The fraction of inspired oxygen (FiO2) will be titrated according to the patient's oxygen saturation target, with a target SpO2 of ≥95% in most patients and 88-92% in patients with type 2 respiratory failure. Gas temperature will be maintained at approximately 34°C with 100% relative humidity.
Patients will undergo standard monitoring during bronchoscopy, including continuous oxygen saturation, heart rate, respiratory rate, and blood pressure monitoring. Arterial blood gas measurements will also be assessed according to the study protocol. Standard topical anesthesia and, when indicated, intravenous sedation will be used. Fiber-optic bronchoscopy will be performed using a flexible video bronchoscope (PENTAX EB-1970TK, PENTAK® COMPANY GmbH, Tokyo, Japan), with diagnostic or therapeutic procedures performed according to clinical indication.
The study will assess oxygenation, ventilation, respiratory parameters, procedural tolerance, treatment escalation, and adverse events. Oxygenation outcomes will include the frequency, duration, depth, and timing of oxygen desaturation during bronchoscopy, as well as changes in the PaO2/FiO2 ratio. Ventilatory outcomes will include changes in PaCO2 and pH. The Respiratory Rate-Oxygenation (ROX) Index will be calculated before bronchoscopy and 1-2 hours after the procedure.
Procedural outcomes will include procedure completion, interruptions, procedure duration, and the need for escalation of respiratory support from HFNC to non-invasive ventilation or invasive mechanical ventilation. Safety outcomes will include major and minor procedural complications and post-procedure complications. Patient comfort and clinical outcomes, including intensive care unit admission, hospital length of stay, and need for mechanical ventilation, will also be assessed.
Predefined criteria will be used for temporary interruption or termination of bronchoscopy and for escalation of respiratory support in cases of severe hypoxemia, respiratory distress, or hemodynamic instability. The study will provide information regarding the feasibility, safety, and effectiveness of HFNC as respiratory support during fiber-optic bronchoscopy in patients with respiratory failure.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants will be eligible for inclusion if they meet all of the following criteria:
Exclusion Criteria:
Participants will be excluded if they meet any of the following criteria:
Participants with respiratory failure undergoing fiber-optic bronchoscopy will receive high-flow nasal cannula (HFNC) oxygen therapy beginning approximately 10 minutes before bronchoscopy, continuing throughout the procedure, and for 1-2 hours after the procedure. HFNC will be delivered using a Vapotherm Precision Flow Hi-VNI system at an initial flow rate of 40 L/min, with FiO2 titrated according to predefined oxygen saturation targets. Respiratory, hemodynamic, procedural, and safety parameters will be monitored before, during, and after bronchoscopy.
Device: High flow nasal canula
High-flow nasal cannula (HFNC) oxygen therapy will be administered using the Vapotherm Precision Flow Hi-VNI system. HFNC will be initiated approximately 10 minutes before fiber-optic bronchoscopy, maintained throughout the procedure, and continued for 1-2 hours after the procedure. The initial flow rate will be 40 L/min and may be adjusted between 10 and 40 L/min according to clinical requirements. FiO2 will be titrated to maintain the predefined oxygen saturation target (SpO2 ≥95% in most patients and 88-92% in patients with type 2 respiratory failure). Gas temperature will be set at approximately 34°C with 100% relative humidity. Continuous monitoring of SpO2, heart rate, respiratory rate, and blood pressure will be performed during the procedure, with additional arterial blood gas and end-tidal CO2 assessment according to the study protocol.
Change in PaO₂/FiO₂ ratio: Change in the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂)
The PaO₂/FiO₂ ratio will be assessed using arterial blood gas analysis to evaluate changes in oxygenation in patients receiving high-flow nasal cannula (HFNC) during fiber-optic bronchoscopy. Arterial blood samples will be collected at baseline before the procedure and 2 hours after its completion while participants are receiving HFNC
Time frame: From baseline before fiber-optic bronchoscopy to 2 hours after completion of the procedure.
Change in PaCO₂: Change in arterial partial pressure of carbon dioxide (PaCO₂) from baseline before fiber-optic bronchoscopy to 2 hours after completion of the procedure.
PaCO₂ will be measured using arterial blood gas analysis (mmHg) to assess changes in ventilation in patients receiving HFNC during fiber-optic bronchoscopy. Arterial blood samples will be collected at baseline before the procedure and 2 hours after its completion while participants are receiving HFNC
Time frame: From baseline before fiber-optic bronchoscopy to 2 hours after completion of the procedure.
Incidence of oxygen desaturation during fiber-optic bronchoscopy
The occurrence of oxygen desaturation, defined as SpO₂ ≤90% lasting more than 10 seconds, during fiber-optic bronchoscopy. The number and duration of desaturation episodes, lowest SpO₂, and time to first desaturation will also be recorded.
Time frame: From initiation of fiber-optic bronchoscopy until completion of the procedure.
Plan to share: Undecided
Started Apr 2026 (actual). Primary completion is estimated for Oct 2027, 18 months after the start.
Of 421 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 18 months is below that.
Counting every sponsor, half of 439 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.