Lung ComplianceNCT03533296
Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children
A study testing Positive end expiratory pressure (PEEP) in people with Lung Compliance, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Lung Compliance
- What is being tested?
- Positive end expiratory pressure (PEEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2018to 20 Dec 2019
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing surgery more than 1 hour under general anesthesia
- American Society Anesthesiologist physical status I, II
Who cannot join
- History of lung resection
- History of bronchopulmonary dysplasia or respiratory distress syndrome
- Abnormalities in chest radiography
- Laparoscopic surgery
- Abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.
- Conditions
- Lung Compliance
- Being tested
- Positive end expiratory pressure (PEEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end expiratory pressure (PEEP)Procedure or surgery
The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Children | Experimental | Children who receive elective surgery under general anesthesia and are supported by mechanical ventilation Receives: Procedure: Positive end expiratory pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean respiratory compliance
Mean static and dynamic compliance
Measured: During 15 minutes after applying each level of PEEP
Secondary outcomes (2)
Compliance profile
We will determine Intratidal compliance-volume profile using the changes in compliance over time
--> I, merely increasing compliance profile; IH, increasing turning into horizontal compliance profile; D, merely decreasing compliance profile; HD, horizontal turning into decreasing compliance profile; IHD, increasing turning into horizontal and further turning into decreasing compliance profile
If compliance profile is I, the PEEP is low. On the other hand, compliance profile is D, PEEP level is considered to be high.
Measured: During 15 minutes after applying each level of PEEP
Airway resistance
Mean airway resistance
Measured: During 15 minutes after applying each level of PEEP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start13 Nov 2018
- Primary completion20 Nov 2019
- Study completion20 Dec 2019
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 Lung ComplianceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533296
- Sponsor's protocol ID
- H1804-101-938
- Status last verified
- Nov 2019
- First submitted
- 11 May 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.
PubMed 32682552
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children
- ClinicalTrials.gov ID
- NCT03533296
- Acronym / sponsor ID
- H1804-101-938
- Conditions
- Lung Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 23 May 2018 (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.
The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | Experimental | Procedure: Positive end expiratory pressure (PEEP)Children who receive elective surgery under general anesthesia and are supported by mechanical ventilation |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children undergoing surgery more than 1 hour under general anesthesia
- American Society Anesthesiologist physical status I, II
Key exclusion criteria (5 listed)
- History of lung resection
- History of bronchopulmonary dysplasia or respiratory distress syndrome
- Abnormalities in chest radiography
- Laparoscopic surgery
- Abdominal 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 |
|---|---|---|
| Positive end expiratory pressure (PEEP)The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated. | Procedure or surgery | Children |
Primary outcome
Mean respiratory compliance
Time frame: During 15 minutes after applying each level of PEEP
Mean static and dynamic compliance
2 secondary outcomes
Compliance profile
Time frame: During 15 minutes after applying each level of PEEP
Airway resistance
Time frame: During 15 minutes after applying each level of PEEP
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 25 Mar 2020.
- Derived from this study: PubMed 32682552Lee JH, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Evaluation of the intratidal compliance profile at different PEEP levels in children with healthy lungs: a prospective, crossover study. Br J Anaesth. 2020 Nov;125(5):818-825. doi: 10.1016/j.bja.2020.06.046. Epub 2020 Jul 15.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive end expiratory pressure (PEEP) in people with Lung Compliance, run by Seoul National University Hospital 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 2 inclusion and 5 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 25 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?
Mean respiratory compliance (time frame: During 15 minutes after applying each level of PEEP). 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 NCT03533296, 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 25 Mar 2020.