The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients

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

• Registration Number: NCT03905733
• Lead Sponsor: Yonsei University

Brief Summary

The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on maintenance of oxygenation and removal of carbon dioxide during apnoeic period in pediatric patients undergoing general anesthesia with rigid bronchoscopy

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Study First Posted: 2019-04-05
• Last Update Posted: 2019-04-05
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 7 or younger who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria

• 1. Patients undergoing extracorporeal membrane oxygenation (ECMO)
• 2. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
• 3. Patients with current maxillofacial trauma or basal skull fracture
• 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
• 5. Extremely low birth weight infant and premature infant less than 28 weeks gestation age
• 6. Patients who had previously undergone rigid bronchoscopy / surgery
• 7. If the parent of subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
general anesthesia with rigid bronchoscopy	Optiflow	Patients 7 years or younger who undergo general anesthesia with rigid bronchoscopy

Primary Outcome Measures

Name	Time	Method
Hypoxia occurs the first time	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 intraoperatively.	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
the lowest oxygen saturation	apnea period during the rigidbroscopic procedure/surgery	the lowest value of oxygen saturation measured percutaneously at extremity.
Occurence of hypoxic event	apnea period during the rigidbroscopic procedure/surgery	Occurence of hypoxic event: Presence or absence of hypoxia(peripheral oxygen saturation fell below 90% ) during rigid bronchoscopy

Secondary Outcome Measures

Name	Time	Method
End-tidal carbon dioxide partial pressure	end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea during intraoperative period.
Arterial oxygen / carbon dioxide partial pressure	shortly before start of apnea (within 30 seconds) and shortly after end of apnea (within 30 seconds)

Trial Locations

Locations (1)

Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of