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NCT Number: NCT04633720

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.

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Key information

Conditions

Respiratory Compliance

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Intratidal compliance profiles in each ventilator settings

    Time frame: 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 outcomes

  1. Respiratory compliance

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

    ml cmH2O-1

  2. Driving pressure

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

    cmH2O

  3. Blood pressure

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

    mmHg

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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