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

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.

Study Overview

• Status: Unknown
• Conditions: Tumor; Foreign Bodies; Stenosis Trachea; Bronchus Tumour
• Intervention / Treatment: Device: Optiflow ™

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    • Contact: Young Jun Oh, M.D., PhD.; Phone Number: 82-2-2224-4428; Email: yjoh@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optiflow; 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)	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.
No Intervention: Standard; standard anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the lowest oxygen saturation	the lowest value of oxygen saturation measured percutaneously at extremity.	apnea period during the rigidbroscopic procedure/surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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 before start of apnea (within 30 seconds)
Arterial oxygen / carbon dioxide partial pressure	shortly after end of apnea (within 30 seconds)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies
• Other Study ID Numbers: 1-2019-0005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No