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Completed

NCT Number: NCT05275309

Determination of Optimal Positive End-expiratory Pressure Using Electrical Impedance Tomography in Children Under General Anesthesia: Comparison Between Supine and Prone Positions

The purpose of this study was to determine the appropriate positive end-expiratory pressure (PEEP) using electrical impedance tomography (EIT) in children under general anesthesia and to investigate whether there is a difference between the supine and prone positions.

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Key information

Conditions

General Anesthesia

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hee-Soo Kim

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 <= years of age who are scheduled for surgery in the prone position under general anesthesia

Exclusion criteria

  • Respiratory distress, bronchopulmonary dysplasia
  • Pneumothorax
  • Increased intracranial pressure
  • History of airway surgery
  • Cervical or thoracic surgery
  • Pulmonary hypertension

Treatment and study plan

Exploration of optimal PEEP in supine and prone position

Other
  • General anesthesia is done in routine manner
  • A sensor for electrical impedance tomography (EIT) is applied around the patient's chest.
  • In supine position, lung recruitment maneuver is done, followed by decremental PEEP trial. Based on EIT parameter, optimal PEEP which induces minimal overdistension and collapse of lungs is determined.
  • One hour after prone position, optimal PEEP is determined again.

Primary outcomes

  1. Optimal PEEP level at spine position

    Time frame: 10 minutes after intubation (supine)

    Optimal PEEP level (cmH2O) determination using electrical impedance tomography at supine position

  2. Optimal PEEP level at prone position

    Time frame: 1 hour after prone positioning (prone)

    Optimal PEEP level (cmH2O) determination using electrical impedance tomography at prone position

Secondary outcomes

  1. Dynamic compliance measured using Electrical impedance tomography

    Time frame: until 1 hour after prone positioning

    ventilation/pressure (ml/cmH2O)

  2. regional ventilation delay measured using Electrical impedance tomography

    Time frame: until 1 hour after prone positioning

    ventilation time delay during one breath (no unit)

  3. pulmonary opening pressure measured using Electrical impedance tomography

    Time frame: until 1 hour after prone positioning

    alveoli opening pressure (cmH2O)

  4. atelectasis/overdistension ratio measured using Electrical impedance tomography

    Time frame: until 1 hour after prone positioning

    The degree comparing atelectasis and overdistension (no unit)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
Jan 20, 2023

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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