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Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant

Primary Purpose

Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional ventilation, group C
pressure support, group PS
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery

Eligibility Criteria

0 Years - 1 Year (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. infant patients aged 0 day to 13 month
  2. American Society of Anesthesiologists (ASA) classification 1~2 who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

  1. patients with symptomatic bronchopulmonary dysplasia
  2. patients with uncorrected congenital heart or pulmonary disease
  3. Hemodynamically unstable requiring preoperative vasopressor administration
  4. fever (>37.5°) or URI symptoms on the day of surgery

Sites / Locations

  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group C

group PS

Arm Description

Outcomes

Primary Outcome Measures

Frequency of atelectasis
Immediately after arriving at the recovery room, lung ultrasound is performed to check for atelectasis.

Secondary Outcome Measures

Frequency of atelectasis
After 30 minutes of staying in the recovery room, lung ultrasound was performed to check for atelectasis.
scoring of atelectasis
Perform atelectasis scoring on 12 parts of the lung
Frequency of desatuation
Check the frequency of desaturation (<95%) during the stay in the recovery room.

Full Information

First Posted
April 29, 2022
Last Updated
May 9, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05373589
Brief Title
Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant
Official Title
Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

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

5. Study Description

Brief Summary
Atelectasis occurs in patients of all ages who receive mechanical ventilation under general anesthesia, and although fatal cases are rare, it is known as a cause of postoperative hypoxia or fever. In pediatric patients, it has a particularly high incidence of 68-100%, and the incidence is inversely proportional to age. Pediatric patients,compared to adults, have a small capacity for functional residual capacity while a high metabolic demand, making them fundamentally vulnerable to hypoxia. Increased atelectasis during anesthesia causes hypoxia not only during anesthesia but also during recovery after anesthesia. Therefore, it is important to establish and apply a strategy to minimize the occurrence of atelectasis during mechanical ventilation under general anesthesia in pediatric patients. The aim of this study is to investigate whether pressure support ventilation at emergence period could reduce the incidence of postoperative atelectasis in infants undergoing surgery under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group C
Arm Type
Experimental
Arm Title
group PS
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
conventional ventilation, group C
Intervention Description
In the conventional ventilation group, after stopping the administration of the inhalation gas, the emergence process is performed by the anesthesiologist assigned to the room. Basically, until spontaneous respiration of the patient is restored, an anesthesiologist can assist respiration by intermittent manual assistance if necessary.
Intervention Type
Other
Intervention Name(s)
pressure support, group PS
Intervention Description
In the pressure support group, after stopping the administration of the inhalation gas, switch to the pressure support mode at the emergence period. PEEP 5cmH20 is applied, and the safety backup ventilation rate is set to 12 breaths/min. The flow trigger is set to 1L/min, and the degree of support is made to be 7-8ml of the predicted body weight, and is decreased as the patient's spontaneous breathing is restored.
Primary Outcome Measure Information:
Title
Frequency of atelectasis
Description
Immediately after arriving at the recovery room, lung ultrasound is performed to check for atelectasis.
Time Frame
Within 5 minutes of arriving at the recovery room
Secondary Outcome Measure Information:
Title
Frequency of atelectasis
Description
After 30 minutes of staying in the recovery room, lung ultrasound was performed to check for atelectasis.
Time Frame
After 30 minutes of stay in the recovery room
Title
scoring of atelectasis
Description
Perform atelectasis scoring on 12 parts of the lung
Time Frame
at the time of admission and after 30 minutes of stay in the recovery room
Title
Frequency of desatuation
Description
Check the frequency of desaturation (<95%) during the stay in the recovery room.
Time Frame
at the time of admission and after 30 minutes of stay in the recovery room

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: infant patients aged 0 day to 13 month American Society of Anesthesiologists (ASA) classification 1~2 who are scheduled for elective surgery under general anesthesia Exclusion Criteria: patients with symptomatic bronchopulmonary dysplasia patients with uncorrected congenital heart or pulmonary disease Hemodynamically unstable requiring preoperative vasopressor administration fever (>37.5°) or URI symptoms on the day of surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Rim Lee
Phone
82-2-2224-4135
Email
manya@yuhs.ac
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Rim Lee
Phone
82-2-2224-4135
Email
manya@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Pressure Support Ventilation During Anesthetic Emergence on Postoperative Atelectasis in Infant

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