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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04633720
Enrollment
43
Registered
2020-11-18
Start date
2020-12-02
Completion date
2021-05-30
Last updated
2022-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Compliance

Brief 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.

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 6 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Intratidal compliance profiles in each ventilator settingsDuring 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.

Secondary

MeasureTime frameDescription
Respiratory complianceDuring general anesthesia (up to about 50 min-1 hr after induction of anesthesia)ml cmH2O-1
Driving pressureDuring general anesthesia (up to about 50 min-1 hr after induction of anesthesia)cmH2O
Blood pressureDuring general anesthesia (up to about 50 min-1 hr after induction of anesthesia)mmHg

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026