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Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

Primary Purpose

Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified HFNC oxygen therapy
Face mask
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years old; Bronchoscopy is required; 150 mmHg ≤ PaO2/FiO2 < 300 mmHg. Exclusion Criteria: Not tolerate HFNC oxygen therapy; Obstruction of nasopharynx cavity; Platelet<60 × 109/L; Need tracheal intubation; The patient has received invasive ventilation.

Sites / Locations

  • Beijing Chao-Yang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Modified HFNC oxygen therapy group

Face mask group

Arm Description

Outcomes

Primary Outcome Measures

Need to increase ventilatory support
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

The incidence of hypoxia during bronchoscopy
Hypoxia is defined as SpO2 < 90%.

Full Information

First Posted
February 27, 2023
Last Updated
July 10, 2023
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05759832
Brief Title
Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy
Official Title
Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure, High-flow Nasal Cannula Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified HFNC oxygen therapy group
Arm Type
Experimental
Arm Title
Face mask group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Modified HFNC oxygen therapy
Intervention Description
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
Intervention Name(s)
Face mask
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Need to increase ventilatory support
Description
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.
Time Frame
Within 24 hours after bronchoscopy
Secondary Outcome Measure Information:
Title
The incidence of hypoxia during bronchoscopy
Description
Hypoxia is defined as SpO2 < 90%.
Time Frame
During bronchoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old; Bronchoscopy is required; 150 mmHg ≤ PaO2/FiO2 < 300 mmHg. Exclusion Criteria: Not tolerate HFNC oxygen therapy; Obstruction of nasopharynx cavity; Platelet<60 × 109/L; Need tracheal intubation; The patient has received invasive ventilation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhao, Dr.
Phone
+8618601342030
Email
xuanben1985@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Wang, Dr.
Organizational Affiliation
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Wang, MD
Phone
+8618601342030
Email
xuanben1985@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Modified HFNC Therapy for ARF Patients Undergoing Flexible Bronchoscopy

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