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

NCT ID: NCT05373589

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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group C

Group Type EXPERIMENTAL

conventional ventilation, group C

Intervention Type OTHER

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.

group PS

Group Type EXPERIMENTAL

pressure support, group PS

Intervention Type OTHER

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.

Interventions

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conventional ventilation, group C

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

pressure support, group PS

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Jeong-Rim Lee

Role: CONTACT

82-2-2224-4135

Facility Contacts

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Jeong-Rim Lee

Role: primary

82-2-2224-4135

Other Identifiers

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4-2022-0119

Identifier Type: -

Identifier Source: org_study_id

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