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

NCT ID: NCT04633720

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2021-05-30

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.

Conditions

Respiratory Compliance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Changes in positive end-expiratory pressure and tidal volume

Intervention Type: OTHER

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

Interventions

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.

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 34686309 (View on PubMed)

Other Identifiers

H2009-175-1162

Identifier Type: -

Identifier Source: org_study_id