The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy (HFNO)
Primary Purpose
Hypoxia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high flow nasal cannula
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring high flow nasal oxygenation, hypoxemia, bronchoscopy, effective flow
Eligibility Criteria
Inclusion Criteria:
- (1) undergoing sedated bronchoscopy
- (2) 18 to 70 years of age;
- (3) American Society of Anaesthesiologists (ASA) class: I-III
Exclusion Criteria:
- (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
- (2) severe hypoxemia (SpO2 < 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
- (3) upper respiratory tract infection or lung infection;
- (4) refusal to participate in this study.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Arm Description
10 L/min of oxygen flow
20 L/min of oxygen flow
30 L/min of oxygen flow
40 L/min of oxygen flow
50 L/min of oxygen flow
60 L/min of oxygen flow
Outcomes
Primary Outcome Measures
the incidence of hypoxemia
hypoxemia was defined as SpO2 < 90%
Secondary Outcome Measures
jaw thrust maneuver
percentage of jaw thrust maneuver
increase of flow rate
percentage of increase of flow rate
bag-mask ventilation
percentage of bag-mask ventilation
Full Information
NCT ID
NCT05298319
First Posted
February 28, 2022
Last Updated
August 6, 2022
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05298319
Brief Title
The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy
Acronym
HFNO
Official Title
The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute [L/min], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.
Detailed Description
It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
high flow nasal oxygenation, hypoxemia, bronchoscopy, effective flow
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
10 L/min of oxygen flow
Arm Title
Group 2
Arm Type
Experimental
Arm Description
20 L/min of oxygen flow
Arm Title
Group 3
Arm Type
Experimental
Arm Description
30 L/min of oxygen flow
Arm Title
Group 4
Arm Type
Experimental
Arm Description
40 L/min of oxygen flow
Arm Title
Group 5
Arm Type
Experimental
Arm Description
50 L/min of oxygen flow
Arm Title
Group 6
Arm Type
Experimental
Arm Description
60 L/min of oxygen flow
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula
Intervention Description
The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.
Primary Outcome Measure Information:
Title
the incidence of hypoxemia
Description
hypoxemia was defined as SpO2 < 90%
Time Frame
during bronchoscopy
Secondary Outcome Measure Information:
Title
jaw thrust maneuver
Description
percentage of jaw thrust maneuver
Time Frame
during bronchoscopy
Title
increase of flow rate
Description
percentage of increase of flow rate
Time Frame
during bronchoscopy
Title
bag-mask ventilation
Description
percentage of bag-mask ventilation
Time Frame
during bronchoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) undergoing sedated bronchoscopy
(2) 18 to 70 years of age;
(3) American Society of Anaesthesiologists (ASA) class: I-III
Exclusion Criteria:
(1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
(2) severe hypoxemia (SpO2 < 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
(3) upper respiratory tract infection or lung infection;
(4) refusal to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Zhang
Phone
15990145873
Email
wendymos@126.com
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Zhang
Phone
1599014587
Email
wendymos@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy
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