Pediatric SurgeryNCT03969173

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

A study testing applying PEEP3, applying PEEP6 and applying PEEP9 in people with Pediatric Surgery, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages Up to 1 yearHealthy volunteers can take part
Conditions the study is for: Pediatric Surgery
What is being tested?: applying PEEP3, applying PEEP6 and applying PEEP9
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteSouth Korea
Study dates: 9 May 2019to 13 Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 1 year
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 120-752

Other trials in South Korea

About this study

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.

Read the 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.

Conditions: Pediatric Surgery
Being tested: applying PEEP3, applying PEEP6, applying PEEP9
Keywords: Children undergoing pediatric general surgery or pediatric urology surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

applying PEEP3Procedure or surgery
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.
applying PEEP6Procedure or surgery
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.
applying PEEP9Procedure or surgery
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.

Study groups in NCT03969173
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Procedure: applying PEEP9

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: before the end of anesthesia

Secondary outcomes (3)

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.
Measured: 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
Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded.
Measured: 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
Peak inspiratory pressure and dynamic compliance on the ventilator monitor during each PEEP are recorded.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201913 Mar 2020

First posted31 May 2019
Study start9 May 2019
Primary completion13 Mar 2020
Study completion13 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03969173
Sponsor's protocol ID: 4-2019-0224
Status last verified: Mar 2020
First submitted: 15 May 2019
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33720065

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of Best PEEP (Positive End-expiratory Pressure) in Anesthetized Infants in Terms of Prevention of Atelectasis
ClinicalTrials.gov ID: NCT03969173
Acronym / sponsor ID: 4-2019-0224
Conditions: Pediatric Surgery
Keywords: Children undergoing pediatric general surgery or pediatric urology surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 9 May 2019 (actual)
Primary completion: 13 Mar 2020 (actual)
Study completion: 13 Mar 2020 (actual)
First posted: 31 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Purpose of research; to determine the appropriate positive end-expiratory pressure to minimize atelectasis during general anesthesia in infants.

Medical Equipment : Ultrasonography with 6 - 13 MHz linear probe, Cardio-Q esophageal Doppler

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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)

Arm	Type	Receives
PEEP3	Active comparator	Procedure: applying PEEP3The 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.
PEEP6	Active comparator	Procedure: applying PEEP6The 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.
PEEP9	Active comparator	Procedure: applying PEEP9The 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.

Who may qualify

Ages: Up to 1 year
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
applying PEEP3The 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 or surgery	PEEP3
applying PEEP6The 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 or surgery	PEEP6
applying PEEP9The 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 or surgery	PEEP9

Primary outcome

Lung atelectasis score after surgery
Time frame: before the end of anesthesia
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.

3 secondary outcomes

Cardiac index
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.
Peak inspiratory pressure
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.
Dynamic compliance
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Derived from this study: PubMed 33720065Park 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing applying PEEP3, applying PEEP6 and applying PEEP9 in people with Pediatric Surgery, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung atelectasis score after surgery (time frame: before the end of anesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.