The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy

Hypoxia Clinical Trial

— HFNO  

Official title:

The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05298319
• Other study ID #: Zhejiang Cancer Hospital
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• high flow nasal cannula
The patients were randomized into 6 groups, each group received different flow of oxygen, to observe the incidence of hypoxemia between different groups.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of hypoxemia	hypoxemia was defined as SpO2 < 90%	during bronchoscopy
Secondary	jaw thrust maneuver	percentage of jaw thrust maneuver	during bronchoscopy
Secondary	increase of flow rate	percentage of increase of flow rate	during bronchoscopy
Secondary	bag-mask ventilation	percentage of bag-mask ventilation	during bronchoscopy