Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05759832
Collaborator
(none)
140
1
2
26
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Modified HFNC oxygen therapy
  • Device: Face mask
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Modified HFNC oxygen therapy group

Device: 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.

Other: Face mask group

Device: Face mask
In the face mask group, oxygen was delivered via a face mask during bronchoscopy. The oxygen flow was set to achieve a saturation of pulse oxygen > 90%.

Outcome Measures

Primary Outcome Measures

  1. Need to increase ventilatory support [Within 24 hours after bronchoscopy]

    The proportion of patients needs to increase ventilatory support, including (1) upgrading respiratory support; (2) increasing parameters of non-invasive mechanical ventilation or modified HFNC.

Secondary Outcome Measures

  1. The incidence of hypoxia during bronchoscopy [During bronchoscopy]

    Hypoxia is defined as SpO2 < 90%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age ≥ 18 years old;

  2. Bronchoscopy is required;

  3. 150 mmHg ≤ PaO2/FiO2 < 300 mmHg.

Exclusion Criteria:
  1. Not tolerate HFNC oxygen therapy;

  2. Obstruction of nasopharynx cavity;

  3. Platelet<60 × 109/L;

  4. Need tracheal intubation;

  5. The patient has received invasive ventilation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chao-Yang Hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Beijing Chao Yang Hospital

Investigators

  • Study Director: Rui Wang, Dr., Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rui Wang, Attending doctors, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT05759832
Other Study ID Numbers:
  • 2023-KE-17
  • PX2023010
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 13, 2023