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CompletedNCT04633720Updated May 5, 2022

Exploration of the Appropriate Combination of Positive End Expiratory Pressure and Tidal Volume Using the Intratidal Compliance Volume Profile in Children

An interventional study of Changes in positive end-expiratory pressure and tidal volume in Respiratory Compliance, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
1 Month to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Compliance
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children undergoing surgery > 1 hour under general anesthesia
  • Children ≤ 6 years
  • American society of anesthesiology physical status I, II

Exclusion criteria

Exclusion Criteria:

  • Previous lung surgery
  • Bronchopulmonary dysplasia, respiratory distress syndrome
  • Other interstitial lung disease
  • Laparoscopic surgery
  • Thoracic surgery, abdominal surgery
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Evaluation of intratidal compliance

    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

    Other: Changes in positive end-expiratory pressure and tidal volume

Interventions

  • OtherChanges in positive end-expiratory pressure and tidal volume

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)

Secondary outcomes

  1. Respiratory compliance

    ml cmH2O-1

    Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)

  2. Driving pressure

    cmH2O

    Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)

  3. Blood pressure

    mmHg

    Time frame: During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04633720
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Nov 18, 2020
Start date
Dec 2, 2020
Primary completion
Apr 30, 2021
Completion
May 30, 2021
Last update
May 5, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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