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

NCT04633720 | Completed DMC

• 1 other identifier: H2009-175-1162
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

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

Secondary Outcomes (3)

• Respiratory compliance

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

• Driving pressure

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

• Blood pressure

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

Study Arms (1)

Evaluation of intratidal compliance

EXPERIMENTAL

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

Changes in positive end-expiratory pressure and tidal volume 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

Evaluation of intratidal compliance

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34686309 DERIVED

MeSH Terms

Interventions

Positive-Pressure Respiration; Tidal Volume

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 18, 2020
• Study Start: December 2, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

KR (1)