High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Tumor; Foreign Bodies; Stenosis Trachea; Bronchus Tumour
• Interventions: Device: Optiflow ™

• Registration Number: NCT03892408
• Lead Sponsor: Yonsei University

Brief Summary

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2019-04-21
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
• 2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria

• 1. Patients with dementia or cognitive impairment
• 2. pregnant women
• 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
• 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
• 5. Patients with current maxillofacial trauma or basal skull fracture
• 6. Patients who had previously undergone rigid bronchoscopy / surgery
• 7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optiflow	Optiflow ™	100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)

Primary Outcome Measures

Name	Time	Method
the lowest oxygen saturation	apnea period during the rigidbroscopic procedure/surgery	the lowest value of oxygen saturation measured percutaneously at extremity.

Secondary Outcome Measures

Name	Time	Method
Hypoxia occurs the first time	intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea)
End-tidal carbon dioxide partial pressure	Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)
Arterial oxygen / carbon dioxide partial pressure	shortly after end of apnea (within 30 seconds)
hypoxemia related surgical interruptions	4) hypoxemia related surgical interruptions during apneic period

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of