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Completed

NCT Number: NCT03856918

Optimal Level of PEEP in Protective One-lung Ventilation

Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.

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Key information

Conditions

Video-Assisted Thoracic Surgery Positive End-Expiratory Pressure Postoperative Atelectasis

Age range

19 year–80 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

  • Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

Exclusion criteria

  • Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
  • Chronic kidney disease
  • Coronary artery disease
  • Pulmonary hypertension
  • Bilateral lung surgery
  • Conversion to thoracotomy
  • American Society of Anesthesiologists physical status IV or more
  • Refusal to participate

Treatment and study plan

PEEP 3 cm of water

Procedure

PEEP of 3 cm of water will be applied during one-lung ventilation.

PEEP 6 cm of water

Procedure

PEEP of 6 cm of water will be applied during one-lung ventilation.

PEEP 9 cm of water

Procedure

PEEP of 9 cm of water will be applied during one-lung ventilation.

Primary outcomes

  1. Modified lung ultrasound score

    Time frame: Postoperative 1 hour

    The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.

Secondary outcomes

  1. Intraoperative desaturation

    Time frame: Average time of 60-90 minutes

    Oxygen saturation by pulse oximetry <95% during one-lung ventilation

  2. Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio

    Time frame: Average time of 60-90 minutes

    partial pressure of arterial oxygen/fraction of inspired oxygen ratio during one-lung ventilation

  3. Postoperative desaturation

    Time frame: Postoperative 24 hours

    Oxygen saturation by pulse oximetry <95%

  4. plasma Tumor Necrosis Factor-α

    Time frame: 10 minutes after initiation of one-lung ventilation

    proinflammatory cytokine

  5. plasma Interleukin-6

    Time frame: 10 minutes after initiation of one-lung ventilation

    proinflammatory cytokine

  6. plasma Interleukin-10

    Time frame: 10 minutes after initiation of one-lung ventilation

    anti-inflammatory cytokine

  7. Postoperative pulmonary complication

    Time frame: Postoperative 7 days

    Composite outcome of atelectasis, pneumonia, acute respiratory distress syndrome, or pulmonary aspiration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 27, 2019
Registry last updated
Apr 18, 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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