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

Not Applicable

Completed

• Conditions: Respiratory Compliance
• Interventions: Other: Changes in positive end-expiratory pressure and tidal volume

• Registration Number: NCT04633720
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-08
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-18
• Study Start: 2020-12-02
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of intratidal compliance	Changes 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. 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

Primary Outcome Measures

Name	Time	Method
Intratidal compliance profiles in each ventilator settings	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.

Secondary Outcome Measures

Name	Time	Method
Driving pressure	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)	cmH2O
Blood pressure	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)	mmHg
Respiratory compliance	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)	ml cmH2O-1

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of