NCT05821114

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

April 7, 2023

Last Update Submit

April 7, 2023

Conditions

Atelectasis, Postoperative Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Changes in Electric Impedance Tomography parameter

    from induction of anesthesia to end of operation, about 3 hours

Study Arms (2)

high flow oxygen

EXPERIMENTAL

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

Other: Head elevation_HOther: Supine_H

Low flow oxygen

ACTIVE COMPARATOR

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

Other: Head elevation_LOther: Supine_L

Interventions

Head elevation_HOTHER

High flow\_Head-elevation

high flow oxygen
Supine_HOTHER

High flow\_Supine

high flow oxygen
Head elevation_LOTHER

Low flow\_head elevation

Low flow oxygen
Supine_LOTHER

Low flow\_supine

Low flow oxygen

Eligibility Criteria

Age1 Month - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients undergoing airway surgery with high flow nasal oxygen

You may not qualify if:

  • Loss of spontaneous ventilation during surgery
  • less than 1 months
  • cyanotic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 20, 2023

Study Start

April 7, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

KR(1)