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End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05821114
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
20.8
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this pilot randomized clinical trial is to test the effects of high flow nasal oxygen and head elevation during awakening from propofol anesthesia in pediatric patients undergoing airway surgery.

The main question[s] it aims to answer are:

  • High flow oxygen can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?

  • Head elevation can decrease the occurence of atelectasis during awakening from propofol anesthesia in pediatric patients?

Researchers will compare high flow oxygen vs low flow oxygen group to see if the use of high flow oxygen decrease the occurence of atelectasis during awakening from propofol anesthesia.

And in each group, the patients will be assigned to supine position vs head elevation position to compare the effects of head elevation during awakening from propofol anesthesia.

Condition or Disease Intervention/Treatment Phase
  • Other: Head elevation_H
  • Other: Supine_H
  • Other: Head elevation_L
  • Other: Supine_L
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effects of High-Flow Nasal Cannula and Body Position On Atelectasis Using Electric Impedance Tomography in Children Awakening From Propofol Anesthesia: A Pilot Randomized Controlled Trial.
Actual Study Start Date :
Apr 7, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: high flow oxygen

Oxygen supply (2L/kg/min.) during awakening from propofol anesthesia

Other: Head elevation_H
High flow_Head-elevation

Other: Supine_H
High flow_Supine
Active Comparator: Low flow oxygen

Oxygen supply (0.3L/kg/min.) during awakening from propofol anesthesia

Other: Head elevation_L
Low flow_head elevation

Other: Supine_L
Low flow_supine

Outcome Measures

Primary Outcome Measures

  1. Changes in Electric Impedance Tomography parameter [from induction of anesthesia to end of operation, about 3 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Pediatric patients undergoing airway surgery with high flow nasal oxygen
Exclusion Criteria:

  • Loss of spontaneous ventilation during surgery

  • less than 1 months

  • cyanotic patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hee-Soo Kim Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05821114
Other Study ID Numbers:
  • 2302-129-1408
First Posted:
Apr 20, 2023
Last Update Posted:
Apr 20, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Atelectasis

Study Results

No Results Posted as of Apr 20, 2023