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

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 Overview

• Status: Completed
• Conditions: Respiratory Compliance
• Intervention / Treatment: Other: Changes in positive end-expiratory pressure and tidal volume

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.; 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During general anesthesia (up to about 50 min-1 hr after induction of anesthesia)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: November 8, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H2009-175-1162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No