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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infants Aged 0 Days to 13 Months Scheduled for Elective Surgery
• Intervention / Treatment: Other: conventional ventilation, group C; Other: pressure support, group PS

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health system, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group C	Other: 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.
EXPERIMENTAL: group PS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of atelectasis	Immediately after arriving at the recovery room, lung ultrasound is performed to check for atelectasis.	Within 5 minutes of arriving at the recovery room

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of atelectasis	After 30 minutes of staying in the recovery room, lung ultrasound was performed to check for atelectasis.	After 30 minutes of stay in the recovery room
scoring of atelectasis	Perform atelectasis scoring on 12 parts of the lung	at the time of admission and after 30 minutes of stay in the recovery room
Frequency of desatuation	Check the frequency of desaturation (<95%) during the stay in the recovery room.	at the time of admission and after 30 minutes of stay in the recovery room

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): February 1, 2023
• Study Completion (ANTICIPATED): February 1, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (ACTUAL): May 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 4-2022-0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No