Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

NCT05759832 | Completed DMC

• 2 other identifiers: 2023-KE-17PX2023010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 24 hours after bronchoscopy

Secondary Outcomes (1)

• A hierarchy of escalated respiratory support forms based on clinical severity

  Within 24 hours after bronchoscopy

Study Arms (2)

Modified HFNC oxygen therapy group

EXPERIMENTAL

Device: Modified HFNC oxygen therapy

Standard oxygen therapy

OTHER

Non-rebreathing reservoir mask

Device: Non-rebreathing reservoir mask

Interventions

Modified HFNC oxygen therapy 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.

Modified HFNC oxygen therapy group

Non-rebreathing reservoir mask 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%.

Standard oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Affiliated Hospital of Qinghai University: collaborator

Study Sites (2)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810000, China

Location

Related Publications (14)

• 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.

  PMID: 27016353 BACKGROUND

• 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.

  PMID: 25003980 BACKGROUND

• 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.

  PMID: 25980431 BACKGROUND

• 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.

  PMID: 23128844 BACKGROUND

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

  PMID: 421510 BACKGROUND

• 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.

  PMID: 1862254 BACKGROUND

• 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.

  PMID: 16924893 BACKGROUND

• 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.

  PMID: 33927023 BACKGROUND

• 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.

  PMID: 29171661 BACKGROUND

• 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.

  PMID: 33105418 BACKGROUND

• 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.

  PMID: 32265363 BACKGROUND

• 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.

  PMID: 25529351 BACKGROUND

• 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.

  PMID: 33262584 BACKGROUND

• 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.

  PMID: 34775948 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Rui Wang, Dr.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctors

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 8, 2023
• Study Start: April 1, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)