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

NCT03892408 | Completed

• 1 other identifier: 1-2019-0005
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Foreign Bodies; Tumor; Stenosis Trachea; Bronchus Tumour

Outcome Measures

Primary Outcomes (1)

• the lowest oxygen saturation

  the lowest value of oxygen saturation measured percutaneously at extremity.

  apnea period during the rigidbroscopic procedure/surgery

Secondary Outcomes (5)

• 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)

• hypoxemia related surgical interruptions

  4) hypoxemia related surgical interruptions during apneic period

Study Arms (2)

Optiflow

EXPERIMENTAL

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

Device: Optiflow ™

Standard

NO INTERVENTION

standard anesthesia

Interventions

Optiflow ™ DEVICE

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.

Optiflow

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Foreign Bodies; Neoplasms; Tracheal Stenosis; Bronchial Neoplasms

Condition Hierarchy (Ancestors)

Wounds and Injuries; Tracheal Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Bronchial Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: triple (Participant, Care Provider, investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective Randomized, open label Trial

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 27, 2019
• Study Start: April 21, 2019
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: June 13, 2024

Record last verified: 2019-03

Locations

KR (1)