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Clinical Trials/NCT03905733
NCT03905733
Unknown
Not Applicable

The Effects of High-flow Nasal Oxygen on Oxygenation During Rigid Bronchoscopy Under General Anesthesia in Pediatric Patients: A Prospective Observational Pilot Study

Yonsei University1 site in 1 country20 target enrollmentApril 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Foreign Bodies
Sponsor
Yonsei University
Enrollment
20
Locations
1
Primary Endpoint
Hypoxia occurs the first time
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2019
End Date
April 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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 with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
  • Extremely low birth weight infant and premature infant less than 28 weeks gestation age
  • Patients who had previously undergone rigid bronchoscopy / surgery
  • If the parent of subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Outcomes

Primary Outcomes

Hypoxia occurs the first time

Time Frame: 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

Time Frame: apnea period during the rigidbroscopic procedure/surgery

the lowest value of oxygen saturation measured percutaneously at extremity.

Occurence of hypoxic event

Time Frame: 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 Outcomes

  • 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))

Study Sites (1)

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