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

Primary Purpose

Pediatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
applying PEEP3
applying PEEP6
applying PEEP9
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Surgery focused on measuring Children undergoing pediatric general surgery or pediatric urology surgery

Eligibility Criteria

undefined - 1 Year (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 1. Congenital heart or lung disease
  • 2. hemodynamic unstable vital sign
  • 3. bronchopulmonary dysplasia
  • 4. laparoscopic surgery

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PEEP3

PEEP6

PEEP9

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cardiac index
The pediatric oesophageal doppler probe is used to compare the cardiac index for PEEP3 (baseline) and PEEP according to each group. Cardiac index: The CardioQ-ODM + can calculate Cardiac Index in Doppler flow mode. Cardiac Index relates the Cardiac Output to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is litres per minute per square metre (l/min/m2). Cardiac Index = Cardiac Output/Body Surface Area The range of cardiac index is 2 to 6 L/min/m2.
Peak inspiratory pressure
Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded.
Dynamic compliance
Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded.

Full Information

First Posted
May 15, 2019
Last Updated
March 30, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03969173
Brief Title
Determination of Best PEEP (Positive End-expiratory Pressure) in Anesthetized Infants in Terms of Prevention of Atelectasis
Official Title
Determination of Best PEEP (Positive End-expiratory Pressure) in Anesthetized Infants in Terms of Prevention of Atelectasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

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
Yes

5. Study Description

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.
Detailed Description
The selected pediatric patients undergo general anesthesia with the method commonly used in the operating room, and mechanical ventilation is applied to the patients after endotracheal intubation. Within five minutes of the start of mechanical ventilation, the degree of baseline lung atelectasis is measured in anterior, lateral, and posterior regions of the upper and lower lungs of both lungs using transthoracic lung ultrasonography, ie, a total of 12 regions. Atelectasis is confirmed by the presence or absence of B-line and juxtapleural consolidation, grading to 0-3 according to severity. That is, the lung atelectasis score can be scored from 0 to 72 points. After ultrasound examination, PEEP is applied in 3 cm H2O. The cardiac index is measured using a transesophageal doppler for 5 minutes before (PEEP=3) and after each application of PEEP (3, 6, 9 cm H2O) according to a randomized, defined group of patients. The applied PEEP is maintained until the end of the operation. After the end of the operation, the score of the lung atelectasis is measured by the same method. Patients who had atelectasis on ultrasonography are recruited three times for 3-5 seconds under 30 cmH2O pressure under the guideline of lung ultrasonography. The anesthesia is terminated by a conventional method and the patient is awakened. The patient is monitored at the recovery room and transferred to the general ward.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Surgery
Keywords
Children undergoing pediatric general surgery or pediatric urology surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP3
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PEEP6
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PEEP9
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
applying PEEP3
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
applying PEEP6
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
applying PEEP9
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung atelectasis score after surgery
Description
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.
Time Frame
before the end of anesthesia
Secondary Outcome Measure Information:
Title
Cardiac index
Description
The pediatric oesophageal doppler probe is used to compare the cardiac index for PEEP3 (baseline) and PEEP according to each group. Cardiac index: The CardioQ-ODM + can calculate Cardiac Index in Doppler flow mode. Cardiac Index relates the Cardiac Output to body surface area (BSA), thus relating heart performance to the size of the individual. The unit of measurement is litres per minute per square metre (l/min/m2). Cardiac Index = Cardiac Output/Body Surface Area The range of cardiac index is 2 to 6 L/min/m2.
Time Frame
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.
Title
Peak inspiratory pressure
Description
Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded.
Time Frame
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.
Title
Dynamic compliance
Description
Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded.
Time Frame
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA PS) I-II 2. pediatric general surgery or pediatric urology surgery under general anesthesia 3. over 6 months of age and less than 13 months of age 4. height and weight are 5-95% of peers Exclusion Criteria: 1. Congenital heart or lung disease 2. hemodynamic unstable vital sign 3. bronchopulmonary dysplasia 4. laparoscopic surgery
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33720065
Citation
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.
Results Reference
derived

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

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