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

Not Applicable

Completed

• Conditions: Hypoxia
• Interventions: Device: high flow nasal cannula

• Registration Number: NCT05298319
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-28
• Study Start: 2022-04-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	high flow nasal cannula	10 L/min of oxygen flow
Group 5	high flow nasal cannula	50 L/min of oxygen flow
Group 3	high flow nasal cannula	30 L/min of oxygen flow
Group 4	high flow nasal cannula	40 L/min of oxygen flow
Group 6	high flow nasal cannula	60 L/min of oxygen flow
Group 2	high flow nasal cannula	20 L/min of oxygen flow

Primary Outcome Measures

Name	Time	Method
the incidence of hypoxemia	during bronchoscopy	hypoxemia was defined as SpO2 \< 90%

Secondary Outcome Measures

Name	Time	Method
jaw thrust maneuver	during bronchoscopy	percentage of jaw thrust maneuver
increase of flow rate	during bronchoscopy	percentage of increase of flow rate
bag-mask ventilation	during bronchoscopy	percentage of bag-mask ventilation

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China