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Clinical Trials/NCT03892408
NCT03892408CompletedNot Applicable

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

Yonsei University2 sites in 2 countries56 target enrollmentStarted: April 21, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
2
Primary Endpoint
the lowest oxygen saturation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Masking Description

triple (Participant, Care Provider, investigator)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4

Exclusion Criteria

  • •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.)

Outcomes

Primary Outcomes

the lowest oxygen saturation

Time Frame: apnea period during the rigidbroscopic procedure/surgery

the lowest value of oxygen saturation measured percutaneously at extremity.

Secondary Outcomes

  • 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 after end of apnea (within 30 seconds))
  • hypoxemia related surgical interruptions(4) hypoxemia related surgical interruptions during apneic period)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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High-flow Nasal Oxygen During Rigid... | Clinical Trial