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End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia

Primary Purpose

Atelectasis, Postoperative Pulmonary

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Head elevation_H
Supine_H
Head elevation_L
Supine_L
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atelectasis, Postoperative Pulmonary

Eligibility Criteria

1 Month - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hee-Soo KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high flow oxygen

Low flow oxygen

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in Electric Impedance Tomography parameter

Secondary Outcome Measures

Full Information

First Posted
April 7, 2023
Last Updated
April 7, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05821114
Brief Title
End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative Pulmonary

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high flow oxygen
Arm Type
Experimental
Arm Description
Oxygen supply (2L/kg/min.) during awakening from propofol anesthesia
Arm Title
Low flow oxygen
Arm Type
Active Comparator
Arm Description
Oxygen supply (0.3L/kg/min.) during awakening from propofol anesthesia
Intervention Type
Other
Intervention Name(s)
Head elevation_H
Intervention Description
High flow_Head-elevation
Intervention Type
Other
Intervention Name(s)
Supine_H
Intervention Description
High flow_Supine
Intervention Type
Other
Intervention Name(s)
Head elevation_L
Intervention Description
Low flow_head elevation
Intervention Type
Other
Intervention Name(s)
Supine_L
Intervention Description
Low flow_supine
Primary Outcome Measure Information:
Title
Changes in Electric Impedance Tomography parameter
Time Frame
from induction of anesthesia to end of operation, about 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hee-Soo Kim
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee-Soo Kim, MD.PhD
Phone
08201052878006
Email
dami0605@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eun-hee Kim, MD. PhD
Phone
82-2-2072-3661
Email
beloveun@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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End-Expiratory Lung Volume in Children Awakening From Propofol Anesthesia

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