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

Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892408
• Other study ID #: 1-2019-0005
• Status: Completed
• Phase: N/A
• Start date: April 21, 2019
• Est. completion date: August 19, 2022

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Bronchus Tumour
• Foreign Bodies
• Stenosis Trachea
• Tumor

Intervention

Device:
• Optiflow ™
supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the lowest oxygen saturation	the lowest value of oxygen saturation measured percutaneously at extremity.	apnea period during the rigidbroscopic procedure/surgery
Secondary	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)
Secondary	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)
Secondary	Arterial oxygen / carbon dioxide partial pressure		shortly before start of apnea (within 30 seconds)
Secondary	Arterial oxygen / carbon dioxide partial pressure		shortly after end of apnea (within 30 seconds)
Secondary	hypoxemia related surgical interruptions		4) hypoxemia related surgical interruptions during apneic period