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Completed

NCT Number: NCT03533296

Individualized Positive End-expiratory Pressure Evaluation Using the Intratidal Compliance-volume Profile in Children

The investigators assess the changes in respiratory compliance according to different levels of positive end expiratory pressure (PEEP) in children under general anesthesia. In addition, the investigators evaluate the intratidal compliance-volume profile at each PEEP level and determine the optimal PEEP level during anesthesia.

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Key information

Conditions

Lung Compliance

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, 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 more than 1 hour under general anesthesia
  • American Society Anesthesiologist physical status I, II

Exclusion criteria

  • History of lung resection
  • History of bronchopulmonary dysplasia or respiratory distress syndrome
  • Abnormalities in chest radiography
  • Laparoscopic surgery
  • Abdominal surgery

Treatment and study plan

Positive end expiratory pressure (PEEP)

Procedure

The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated.

Primary outcomes

  1. Mean respiratory compliance

    Time frame: During 15 minutes after applying each level of PEEP

    Mean static and dynamic compliance

Secondary outcomes

  1. Compliance profile

    Time frame: During 15 minutes after applying each level of PEEP

    We will determine Intratidal compliance-volume 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.

  2. Airway resistance

    Time frame: During 15 minutes after applying each level of PEEP

    Mean airway resistance

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 23, 2018
Registry last updated
Mar 25, 2020

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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