Acute Hypoxemic Respiratory FailureNCT05759832

Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

A study testing Modified HFNC oxygen therapy and Non-rebreathing reservoir mask in people with Acute Hypoxemic Respiratory Failure and High-flow Nasal Cannula Oxygen, run by Beijing Chao Yang Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen
What is being tested?: Modified HFNC oxygen therapy and Non-rebreathing reservoir mask
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 2 sitesChina
Study dates: 1 Apr 2023to 30 Jul 2025
Phase: Interventional
Are there results?: None posted in the registry

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

Age ≥18 years;
Respiratory failure defined as a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg;
Clinical indication for FB to diagnose or treat pulmonary disease.

Who cannot join

Pre-existing endotracheal intubation or tracheostomy;
Required immediate endotracheal intubation;
PaO2/FiO2 <150 mm Hg;
Platelet count <60 × 109/L;
History of myocardial infarction within the past 6 weeks;
Nasopharyngeal obstruction or blockage;
Presence of chest skin lesions contraindicating the application of electrical impedance tomography (EIT);
Intolerance to HFNC oxygen therapy.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810000

Other trials in China

About this study

Official title: Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy

Acute respiratory failure (AFR) is a serious condition that requires prompt and appropriate intervention to prevent further deterioration and improve outcomes. Bronchoscopy is a commonly used diagnostic and therapeutic procedure in patients with respiratory failure. However, traditional low-flow oxygen supplementation during bronchoscopy may not provide adequate oxygenation and ventilation, leading to complications and worsening of the patient's condition.

High-flow nasal cannula therapy has improved oxygenation and ventilation in critically ill patients, making it a promising alternative to traditional oxygen supplementation during bronchoscopy. The bronchoscope is passed through the nose during all procedures in our center. HFNC oxygen therapy is applied to both nostrils. The bronchoscope occupies one of the nares receiving oxygen therapy during bronchoscopy. As a result, the application of HFNC needs to be optimized. Therefore, the investigators designed a modified HFNC with a single cannula. However, limited data exist on the safety and efficacy of modified HFNC therapy in patients with respiratory failure undergoing bronchoscopy.

Therefore, the aim of this study is to evaluate the impact of modified HFNC therapy on the outcomes of undergoing bronchoscopy in patients with ARF. The findings of this study will contribute to understanding the role of modified HFNC therapy in managing ARF and inform clinical practice.

Conditions: Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen
Being tested: Modified HFNC oxygen therapy, Non-rebreathing reservoir mask
Medical subject headings: Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified HFNC oxygen therapyDevice
In the modified HFNC group, high-flow devices (AIRVOTM 2; Fisher \& Paykel Healthcare, Auckland, New Zealand) were utilized for respiratory support. The nasal cannula used was a modified single nasal cannula.
Non-rebreathing reservoir maskDevice
In the non-rebreathing reservoir mask group, oxygen was delivered via a non-rebreathing reservoir mask during bronchoscopy. The oxygen flow was set to achieve a saturation of pulse oxygen > 90%.

Study groups in NCT05759832
Study group	Role	What they receive
Modified HFNC oxygen therapy group	Experimental	Not described Receives: Device: Modified HFNC oxygen therapy
Standard oxygen therapy	Other	Non-rebreathing reservoir mask Receives: Device: Non-rebreathing reservoir mask

What is being measured

The primary outcome is the main question the study is designed to answer.

Need to increase ventilatory support
The primary outcome was the need for respiratory support escalation within 24 hours after FB. Escalation was defined as meeting any of the following criteria:
1. Escalation to invasive mechanical ventilation (IMV);
2. Escalation to non-invasive ventilation (NIV);
3. Escalation to HFNC oxygen therapy;
4. An increase in support parameters without changing the level of respiratory support: For NIV patients: a >20% increase in inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), or fraction of inspired oxygen (FiO2); For HFNO patients: a >20% increase in flow rate or FiO2; For low-flow nasal oxygen (LFNO) therapy patients: a >50% increase in oxygen flow rate.
Measured: Within 24 hours after bronchoscopy

Secondary outcomes (1)

A hierarchy of escalated respiratory support forms based on clinical severity
A hierarchical composite outcome, assessed in a fixed sequence: escalation to IMV, escalation to NIV, escalation to HFNO therapy, and an increase in support parameters without changing the level of respiratory support.
Measured: Within 24 hours after bronchoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202330 Jul 2025

First posted8 Mar 2023
Study start1 Apr 2023
Primary completion30 Jul 2025
Study completion30 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05759832
Sponsor's protocol ID: 2023-KE-17
Other IDs: PX2023010
Status last verified: Nov 2025
First submitted: 27 Feb 2023
Last updated: 21 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
PubMed 27016353
Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
PubMed 25003980
Del Sorbo L, Ferguson ND. High-Flow Nasal Cannulae or Noninvasive Ventilation for Management of Postoperative Respiratory Failure. JAMA. 2015 Jun 16;313(23):2325-6. doi: 10.1001/jama.2015.5304. No abstract available.
PubMed 25980431
Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.
PubMed 23128844
Miller EJ. Hypoxemia during fiberoptic bronchoscopy. Chest. 1979 Jan;75(1):103. doi: 10.1378/chest.75.1.103b. No abstract available.
PubMed 421510
Pirozynski M, Sliwinski P, Radwan L, Zielinski J. Bronchoalveolar lavage: comparison of three commonly used procedures. Respiration. 1991;58(2):72-6. doi: 10.1159/000195900.
PubMed 1862254
Fang WF, Chen YC, Chung YH, Woon WT, Tseng CC, Chang HW, Lin MC. Predictors of oxygen desaturation in patients undergoing diagnostic bronchoscopy. Chang Gung Med J. 2006 May-Jun;29(3):306-12.
PubMed 16924893
Longhini F, Pelaia C, Garofalo E, Bruni A, Placida R, Iaquinta C, Arrighi E, Perri G, Procopio G, Cancelliere A, Rovida S, Marrazzo G, Pelaia G, Navalesi P. High-flow nasal cannula oxygen therapy for outpatients undergoing flexible bronchoscopy: a randomised controlled trial. Thorax. 2022 Jan;77(1):58-64. doi: 10.1136/thoraxjnl-2021-217116. Epub 2021 Apr 29.
PubMed 33927023
Douglas N, Ng I, Nazeem F, Lee K, Mezzavia P, Krieser R, Steinfort D, Irving L, Segal R. A randomised controlled trial comparing high-flow nasal oxygen with standard management for conscious sedation during bronchoscopy. Anaesthesia. 2018 Feb;73(2):169-176. doi: 10.1111/anae.14156. Epub 2017 Nov 24.
PubMed 29171661
Irfan M, Ahmed M, Breen D. Assessment of High Flow Nasal Cannula Oxygenation in Endobronchial Ultrasound Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2021 Apr 1;28(2):130-137. doi: 10.1097/LBR.0000000000000719.
PubMed 33105418
Ben-Menachem E, McKenzie J, O'Sullivan C, Havryk AP. High-flow Nasal Oxygen Versus Standard Oxygen During Flexible Bronchoscopy in Lung Transplant Patients: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Oct;27(4):259-265. doi: 10.1097/LBR.0000000000000670.
PubMed 32265363
Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.
PubMed 25529351
Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 2020.
PubMed 33262584
Wang R, Li HC, Li XY, Tang X, Chu HW, Yuan X, Tong ZH, Sun B. Modified high-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a randomized clinical trial. BMC Pulm Med. 2021 Nov 14;21(1):367. doi: 10.1186/s12890-021-01744-8.
PubMed 34775948
Wang R, Zhao Y, Lan N, Wang W, Tang X, Li T, Liu X, Li H, Meng L, Xu Z, Wang L, Sun B, Gan G. High-flow nasal oxygen therapy via a single-prong cannula interface during bronchoscopy in patients with acute respiratory failure: a two-center, open-label, randomized controlled trial. Ann Intensive Care. 2026 May 12;16:100081. doi: 10.1016/j.aicoj.2026.100081. eCollection 2026.
PubMed 42179655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
RecruitingObservational study
Brain-lung Interaction During Acute Respiratory Failure
Acute Respiratory Failure
RecruitingPhase 2
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Acute Hypoxemic Respiratory Failure

All Acute Hypoxemic Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy
ClinicalTrials.gov ID: NCT05759832
Acronym / sponsor ID: 2023-KE-17
Conditions: Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Beijing Chao Yang HospitalUniversity, hospital or other
Collaborators: Affiliated Hospital of Qinghai University
Study start: 1 Apr 2023 (actual)
Primary completion: 30 Jul 2025 (actual)
Study completion: 30 Jul 2025 (actual)
First posted: 8 Mar 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Modified HFNC oxygen therapy group	Experimental	Device: Modified HFNC oxygen therapy
Standard oxygen therapy	Other	Device: Non-rebreathing reservoir maskNon-rebreathing reservoir mask

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥18 years;
Respiratory failure defined as a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg;
Clinical indication for FB to diagnose or treat pulmonary disease.

Key exclusion criteria (8 listed)

Pre-existing endotracheal intubation or tracheostomy;
Required immediate endotracheal intubation;
PaO2/FiO2 <150 mm Hg;
Platelet count <60 × 109/L;
History of myocardial infarction within the past 6 weeks;

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
Modified HFNC oxygen therapyIn the modified HFNC group, high-flow devices (AIRVOTM 2; Fisher \& Paykel Healthcare, Auckland, New Zealand) were utilized for respiratory support. The nasal cannula used was a modified single nasal cannula.	Device	Modified HFNC oxygen therapy group
Non-rebreathing reservoir maskIn the non-rebreathing reservoir mask group, oxygen was delivered via a non-rebreathing reservoir mask during bronchoscopy. The oxygen flow was set to achieve a saturation of pulse oxygen > 90%.	Device	Standard oxygen therapy

Primary outcome

Need to increase ventilatory support
Time frame: Within 24 hours after bronchoscopy
The primary outcome was the need for respiratory support escalation within 24 hours after FB. Escalation was defined as meeting any of the following criteria: 1. Escalation to invasive mechanical ventilation (IMV); 2. Escalation to non-invasive ventilation (NIV); 3. Escalation to HFNC oxygen therapy; 4. An increase in support parameters without changing the level of respiratory support: For NIV patients: a >20% increase in inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), or fraction of inspired oxygen (FiO2); For HFNO patients: a >20% increase in flow rate or FiO2; For low-flow nasal oxygen (LFNO) therapy patients: a >50% increase in oxygen flow rate.

1 secondary outcome

A hierarchy of escalated respiratory support forms based on clinical severity
Time frame: Within 24 hours after bronchoscopy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Background: PubMed 27016353Nishimura M. High-Flow Nasal Cannula Oxygen Therapy in Adults: Physiological Benefits, Indication, Clinical Benefits, and Adverse Effects. Respir Care. 2016 Apr;61(4):529-41. doi: 10.4187/respcare.04577.
Background: PubMed 25003980Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
Background: PubMed 25980431Del Sorbo L, Ferguson ND. High-Flow Nasal Cannulae or Noninvasive Ventilation for Management of Postoperative Respiratory Failure. JAMA. 2015 Jun 16;313(23):2325-6. doi: 10.1001/jama.2015.5304. No abstract available.
Background: PubMed 23128844Braunlich J, Beyer D, Mai D, Hammerschmidt S, Seyfarth HJ, Wirtz H. Effects of nasal high flow on ventilation in volunteers, COPD and idiopathic pulmonary fibrosis patients. Respiration. 2013;85(4):319-25. doi: 10.1159/000342027. Epub 2012 Nov 1.
Background: PubMed 421510Miller EJ. Hypoxemia during fiberoptic bronchoscopy. Chest. 1979 Jan;75(1):103. doi: 10.1378/chest.75.1.103b. No abstract available.
Background: PubMed 1862254Pirozynski M, Sliwinski P, Radwan L, Zielinski J. Bronchoalveolar lavage: comparison of three commonly used procedures. Respiration. 1991;58(2):72-6. doi: 10.1159/000195900.
Background: PubMed 16924893Fang WF, Chen YC, Chung YH, Woon WT, Tseng CC, Chang HW, Lin MC. Predictors of oxygen desaturation in patients undergoing diagnostic bronchoscopy. Chang Gung Med J. 2006 May-Jun;29(3):306-12.
Background: PubMed 33927023Longhini F, Pelaia C, Garofalo E, Bruni A, Placida R, Iaquinta C, Arrighi E, Perri G, Procopio G, Cancelliere A, Rovida S, Marrazzo G, Pelaia G, Navalesi P. High-flow nasal cannula oxygen therapy for outpatients undergoing flexible bronchoscopy: a randomised controlled trial. Thorax. 2022 Jan;77(1):58-64. doi: 10.1136/thoraxjnl-2021-217116. Epub 2021 Apr 29.
Background: PubMed 29171661Douglas N, Ng I, Nazeem F, Lee K, Mezzavia P, Krieser R, Steinfort D, Irving L, Segal R. A randomised controlled trial comparing high-flow nasal oxygen with standard management for conscious sedation during bronchoscopy. Anaesthesia. 2018 Feb;73(2):169-176. doi: 10.1111/anae.14156. Epub 2017 Nov 24.
Background: PubMed 33105418Irfan M, Ahmed M, Breen D. Assessment of High Flow Nasal Cannula Oxygenation in Endobronchial Ultrasound Bronchoscopy: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2021 Apr 1;28(2):130-137. doi: 10.1097/LBR.0000000000000719.
Background: PubMed 32265363Ben-Menachem E, McKenzie J, O'Sullivan C, Havryk AP. High-flow Nasal Oxygen Versus Standard Oxygen During Flexible Bronchoscopy in Lung Transplant Patients: A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2020 Oct;27(4):259-265. doi: 10.1097/LBR.0000000000000670.
Background: PubMed 25529351Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.
Individual participant dataSharing planned: No

Related trials for Acute Hypoxemic Respiratory Failure

Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS), Acute Hypoxemic Respiratory Failure
RecruitingObservational study
Brain-lung Interaction During Acute Respiratory Failure
Acute Respiratory Failure
RecruitingPhase 2
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Acute Hypoxemic Respiratory Failure

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. This study is not recruiting at the moment.

Rui Wang, Dr. study director

Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need to increase ventilatory support (time frame: Within 24 hours after bronchoscopy). 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 NCT05759832, which also lists 15 linked publications.

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 21 Nov 2025.