Respiratory ComplianceNCT04633720
Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children
A study testing Changes in positive end-expiratory pressure and tidal volume in people with Respiratory Compliance, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In children under 6 years of age undergoing regular surgery during general anesthesia, the intratidal compliance profile is evaluated when different tidal volumes are applied at different positive end expiratory pressures. Then determine the most appropriate combination of positive end-tidal pressure and tidal volume. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Respiratory Compliance
- What is being tested?
- Changes in positive end-expiratory pressure and tidal volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2020to 30 May 2021
- 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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing surgery > 1 hour under general anesthesia
- Children ≤ 6 years
- American society of anesthesiology physical status I, II
Who cannot join
- Previous lung surgery
- Bronchopulmonary dysplasia, respiratory distress syndrome
- Other interstitial lung disease
- Laparoscopic surgery
- Thoracic surgery, abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance-volume Profile in Children
In children under 6 years of age undergoing regular surgery during general anesthesia, the intratidal compliance profile is evaluated when different tidal volumes are applied at different positive end expiratory pressures.
Then determine the most appropriate combination of positive end-tidal pressure and tidal volume.
- Conditions
- Respiratory Compliance
- Being tested
- Changes in positive end-expiratory pressure and tidal volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in positive end-expiratory pressure and tidal volumeOther
When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order.
Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of intratidal compliance | Experimental | When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order.
1. Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg
2. Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg
3. Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg
4. Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg Receives: Other: Changes in positive end-expiratory pressure and tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratidal compliance profiles in each ventilator settings
The investigators will determine Intratidal compliance 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 general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Secondary outcomes (3)
Respiratory compliance
ml cmH2O-1
Measured: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Driving pressure
cmH2O
Measured: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Blood pressure
mmHg
Measured: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start2 Dec 2020
- Primary completion30 Apr 2021
- Study completion30 May 2021
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 Respiratory 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633720
- Sponsor's protocol ID
- H2009-175-1162
- Status last verified
- May 2022
- First submitted
- 8 Nov 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee JH, Kang P, Song IS, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Determining optimal positive end-expiratory pressure and tidal volume in children by intratidal compliance: a prospective observational study. Br J Anaesth. 2022 Jan;128(1):214-221. doi: 10.1016/j.bja.2021.09.024. Epub 2021 Oct 20.
PubMed 34686309
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance-volume Profile in Children
- ClinicalTrials.gov ID
- NCT04633720
- Acronym / sponsor ID
- H2009-175-1162
- Conditions
- Respiratory Compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 18 Nov 2020 (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.
In children under 6 years of age undergoing regular surgery during general anesthesia, the intratidal compliance profile is evaluated when different tidal volumes are applied at different positive end expiratory pressures.
Then determine the most appropriate combination of positive end-tidal pressure and tidal volume.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of intratidal compliance | Experimental | Other: Changes in positive end-expiratory pressure and tidal volumeWhen the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order. 1. Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg 2. Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg 3. Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg 4. Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children undergoing surgery > 1 hour under general anesthesia
- Children ≤ 6 years
- American society of anesthesiology physical status I, II
Key exclusion criteria (5 listed)
- Previous lung surgery
- Bronchopulmonary dysplasia, respiratory distress syndrome
- Other interstitial lung disease
- Laparoscopic surgery
- Thoracic 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 |
|---|---|---|
| Changes in positive end-expiratory pressure and tidal volumeWhen the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order. Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg | Other | Evaluation of intratidal compliance |
Primary outcome
Intratidal compliance profiles in each ventilator settings
Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
The investigators will determine Intratidal compliance 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.
3 secondary outcomes
Respiratory compliance
Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Driving pressure
Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
Blood pressure
Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)
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 5 May 2022.
- Derived from this study: PubMed 34686309Lee JH, Kang P, Song IS, Ji SH, Lee HC, Jang YE, Kim EH, Kim HS, Kim JT. Determining optimal positive end-expiratory pressure and tidal volume in children by intratidal compliance: a prospective observational study. Br J Anaesth. 2022 Jan;128(1):214-221. doi: 10.1016/j.bja.2021.09.024. Epub 2021 Oct 20.
- 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.
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 Changes in positive end-expiratory pressure and tidal volume in people with Respiratory 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 3 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 5 May 2022. 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?
Intratidal compliance profiles in each ventilator settings (time frame: During general anesthesia (up to about 50 min-1 hr after induction 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 NCT04633720, 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 5 May 2022.