Determination of Best PEEP (Positive End-expiratory Pressure) in Anesthetized Infants in Terms of Prevention of Atelectasis

NCT03969173 | Completed DMC

• 1 other identifier: 4-2019-0224
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of research; to determine the appropriate positive end-expiratory pressure to minimize atelectasis during general anesthesia in infants. Study design : Application of one pressure of PEEP among 3, 6, or 9 cmH2O during mechanical positive ventilation for general anesthesia to randomly assigned infants over 6 months to 13 months of age . Immediately after the start of anesthesia (PEEP=0) and before the end of anesthesia, the score of atelectasis is measured by lung ultrasonography with the standardized method. The scores at PEEP3, PEEP6, and PEEP9 will be compared to identify the appropriate PEEP at which atelectasis is the least likely to occur during anesthesia. Medical Equipment : Ultrasonography with 6 - 13 MHz linear probe, Cardio-Q esophageal Doppler The number of target subjects: According to the results of previous studies, the lung ultrasound score by ultrasonography at the end of anesthesia was 28.5 (IQR 21.8-37) without any recruitment (PEEP 0 cmH2O) (IQR 6-21.3). When PEEP of 5 cmH2O was maintained, the lung ultrasound score is 12.5 (IQR 6-21.3), which is lower than PEEP 0. It is assumed that the score at PEEP3 is 20, the score at optimal PEEP is 10, and the standard deviation is 11. Bonferroni correction is required for statistical analysis. In comparison between the two groups, alpha is used as the Bonferroni corrected alpha level of 0.05 / 3 = 0.017. The significance level alpha is fixed at 0.017 and the number of samples considering the 10% dropout rate when the power (1-β) is 80% is required to be 30 for each group. Data analysis and statistical methods: Atelectasis score, cardiac index, peak inspiratory pressure, and dynamic compliance will be compared by t-test between groups(PEEP3 vs PEEP 6, PEEP 3 vs PEEP 9, PEEP 6 vs PEEP 9). P \< 0.017 is going to be considered statistically significant.

Conditions

Pediatric Surgery

Keywords

Children undergoing pediatric general surgery or pediatric urology surgery

Outcome Measures

Primary Outcomes (1)

• Lung atelectasis score after surgery

  Before the end of anesthesia, the degree of atelectasis is measured by lung ultrasonography and scored according to the standardized method. Comparison of the scores at PEEP3, PEEP6, and PEEP9 to identify the appropriate PEEP at which atelectasis is the least likely to occur during anesthesia. Lung atelectasis score: The 6-13 MHz linear probe of the ultrasonic device is applied perpendicular to the patient's ribs and evaluated using a 2 dimensional classic view. Transthoracic pulmonary ultrasound imaging is performed in 12 areas. One thoracic region is divided into 6 zones (caudal anterior, caudal lateral, caudal posterior, cranial anterior, cranial lateral, and cranial posterior) by three longitudinal lines (parasternal, anterior, and posterior axilla) and two axial lines (just above the diaphragm, nipple line). The degree of atelectasis(0-72 points) is the sum of the consolidation score (0-36 points) and the B-line score (0-36 points) in 12 areas.

  before the end of anesthesia

Secondary Outcomes (3)

• Cardiac index

  During surgery, the cardiac index is measured using a transesophageal doppler for 5 minutes each before and after application of PEEP (3, 6, 9 cm H 2 O) according to the randomized, defined group of patients.

• Peak inspiratory pressure

  During surgery, the cardiac index is measured using a transesophageal doppler for 5 minutes each before and after application of PEEP (3, 6, 9 cm H 2 O) according to the randomized, defined group of patients.

• Dynamic compliance

  During surgery, the cardiac index is measured using a transesophageal doppler for 5 minutes each before and after application of PEEP (3, 6, 9 cm H 2 O) according to the randomized, defined group of patients.

Study Arms (3)

PEEP3

ACTIVE COMPARATOR

The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP. Apply PEEP (3 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation.

Procedure: applying PEEP3

PEEP6

ACTIVE COMPARATOR

The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP. Apply PEEP (6 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation.

Procedure: applying PEEP6

PEEP9

ACTIVE COMPARATOR

The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP. Apply PEEP (9 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation.

Procedure: applying PEEP9

Interventions

applying PEEP3 PROCEDURE

The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP. Apply PEEP (3 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation.

PEEP3

applying PEEP6 PROCEDURE

The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP. Apply PEEP (6 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation.

PEEP6

applying PEEP9 PROCEDURE

The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP. Apply PEEP (9 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation.

PEEP9

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. American Society of Anesthesiologists (ASA PS) I-II
• \. pediatric general surgery or pediatric urology surgery under general anesthesia
• \. over 6 months of age and less than 13 months of age
• \. height and weight are 5-95% of peers

You may not qualify if:

• \. Congenital heart or lung disease
• \. hemodynamic unstable vital sign
• \. bronchopulmonary dysplasia
• \. laparoscopic surgery

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Park S, Lee JH, Kim HJ, Choi H, Lee JR. Optimal positive end-expiratory pressure to prevent anaesthesia-induced atelectasis in infants: A prospective, randomised, double-blind trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1019-1025. doi: 10.1097/EJA.0000000000001483.

  PMID: 33720065 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The physician who directly anesthetize the patient should not be aware of the patient's placement due to the nature of the study design and maintenance of anesthesia. The ultrasound examination of the patient's degree of atelectasis and data collection of cardiac index data was limited to a single anesthesiologist without knowing which group the patient is in. Blind cancellation is performed after data analysis is completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is divided into the following three groups according to PEEP to be applied during anesthesia. Test group: PEEP6 group (6 cmH2O), PEEP9 group (9 cmH2O) control group: PEEP3 group (PEEP 3 cmH2O)

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 31, 2019
• Study Start: May 9, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)