Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

NCT ID: NCT05759832

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Hypoxemic Respiratory Failure High-flow Nasal Cannula Oxygen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified HFNC oxygen therapy group

Group Type EXPERIMENTAL

Modified HFNC oxygen therapy

Intervention Type DEVICE

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.

Standard oxygen therapy

Non-rebreathing reservoir mask

Group Type OTHER

Non-rebreathing reservoir mask

Intervention Type DEVICE

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%.

Interventions

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Modified HFNC oxygen therapy

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.

Intervention Type DEVICE

Non-rebreathing reservoir mask

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%.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Qinghai University

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rui Wang

Attending doctors

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rui Wang, Dr.

Role: STUDY_DIRECTOR

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

Locations

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Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 27016353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25003980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25980431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23128844 (View on PubMed)

Miller EJ. Hypoxemia during fiberoptic bronchoscopy. Chest. 1979 Jan;75(1):103. doi: 10.1378/chest.75.1.103b. No abstract available.

Reference Type BACKGROUND
PMID: 421510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1862254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16924893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33927023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29171661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33105418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32265363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25529351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33262584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34775948 (View on PubMed)

Other Identifiers

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PX2023010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-KE-17

Identifier Type: -

Identifier Source: org_study_id

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