Respiratory FailureNCT07880964
Role of HFNC During FOB in Patients With Respiratory Failure
A study testing High flow nasal canula in people with Respiratory Failure and Respiratory Failure With Hypercapnia, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Failure With Hypercapnia
- What is being tested?
- High flow nasal canula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible for inclusion if they meet all of the following criteria:
- Adult patients undergoing clinically indicated fiber-optic bronchoscopy.
- Patients with respiratory failure requiring supplemental oxygen or respiratory support.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Patients requiring immediate endotracheal intubation or invasive mechanical ventilation before bronchoscopy.
- Patients with severe or refractory hypoxemia despite maximal non-invasive oxygen/respiratory support before the procedure.
- Hemodynamic instability that precludes safe fiber-optic bronchoscopy.
- Patients with contraindications to fiber-optic bronchoscopy or to the planned bronchoscopy procedure.
- Patients who refuse or withdraw informed consent.
- Patients in whom HFNC cannot be safely applied or tolerated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Mohammed Shehta, associate professor, 01004344106, dr_mshehta@mans.edu.eg
About this study
Official title: Role of High Flow Nasal Cannula During Fiber-optic Bronchoscopy in Patients With Respiratory Failure
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.
Read the detailed description
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.
- Being tested
- High flow nasal canula
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal canulaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal canula | Experimental | 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. Receives: Device: High flow nasal canula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From baseline before fiber-optic bronchoscopy to 2 hours after completion of the procedure.
Secondary outcomes (1)
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.
Measured: From initiation of fiber-optic bronchoscopy until completion of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start12 Apr 2026
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-arm, pre-post interventional study in which patients with respiratory failure undergoing fiber-optic bronchoscopy receive high-flow nasal cannula (HFNC) before, during, and after the procedure. Clinical, respiratory, hemodynamic, procedural, and safety outcomes are assessed during and after bronchoscopy and compared with baseline measurements.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shehta, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880964
- Sponsor's protocol ID
- MD.26.03.1085
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei C, Ma S, Wang J, Yang N, Wang D, Yuan L, Wang Y. The effectiveness of transnasal high flow nasal cannula in bronchoscopy under sedation: a systematic review and meta-analysis. Front Med (Lausanne). 2024 Jul 10;11:1428431. doi: 10.3389/fmed.2024.1428431. eCollection 2024.
PubMed 39050533
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of High Flow Nasal Cannula During Fiber-optic Bronchoscopy in Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT07880964
- Acronym / sponsor ID
- MD.26.03.1085
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Apr 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-arm, pre-post interventional study in which patients with respiratory failure undergoing fiber-optic bronchoscopy receive high-flow nasal cannula (HFNC) before, during, and after the procedure. Clinical, respiratory, hemodynamic, procedural, and safety outcomes are assessed during and after bronchoscopy and compared with baseline measurements.
| Arm | Type | Receives |
|---|---|---|
| high flow nasal canula | Experimental | Device: High flow nasal canulaParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients undergoing clinically indicated fiber-optic bronchoscopy.
- Patients with respiratory failure requiring supplemental oxygen or respiratory support.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Participants will be excluded if they meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal canulaHigh-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. | Device | high flow nasal canula |
Primary outcome
Change in PaO₂/FiO₂ ratio: Change in the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂)
Time frame: From baseline before fiber-optic bronchoscopy to 2 hours after completion of the procedure.
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
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.
Time frame: 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
1 secondary outcome
Incidence of oxygen desaturation during fiber-optic bronchoscopy
Time frame: From initiation of fiber-optic bronchoscopy until completion of the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Results publication: PubMed 39050533Wei C, Ma S, Wang J, Yang N, Wang D, Yuan L, Wang Y. The effectiveness of transnasal high flow nasal cannula in bronchoscopy under sedation: a systematic review and meta-analysis. Front Med (Lausanne). 2024 Jul 10;11:1428431. doi: 10.3389/fmed.2024.1428431. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow nasal canula in people with Respiratory Failure and Respiratory Failure With Hypercapnia, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Shehta, associate professor-chest med. (+201004344106, dr_mshehta@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaO₂/FiO₂ ratio: Change in the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂) (time frame: From baseline before fiber-optic bronchoscopy to 2 hours after completion of the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07880964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.