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Completed

NCT Number: NCT04258202

Ventilator-driven Alveolar Recruitment Maneuver

During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung volume but it remains unknown which method is most effective. The primary aim was to compare the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20 cmH20).

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Key information

Conditions

Postoperative Atelectasis Atelectasis Lung Diseases Pulmonary Atelectasis Recruitment Respiratory Tract Diseases Ventilator Lung

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung medical center

Seoul, 06351, South Korea

About this study

General anesthesia promotes the formation of atelectasis, which negatively impacts respiratory function and may be associated with subsequent pulmonary complications. Especially, during laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics, suggesting that performing an Alveolar recruitment maneuvers after intubation, circuit disconnection, position change, intraabdominal gas infiltration.

Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on the anaesthesia machine with the adjustable pressure-limiting valve set to the desired inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when switching back to the ventilator circuit, which results in re-collapse of alveoli. For this reason, investigators try to compare the methods of the ventilator-driven ARM.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who receive laparoscopic surgery in trendelenberg position

Exclusion criteria

  • Patients who are simultaneously participating in other studies
  • Patients who are scheduled to leave the intensive care unit after surgery
  • Patients with obstructive or restrictive pattern of Severe or moderate grade on Pulmonary function test
  • High risk in cardiovascular events (expected postoperative cardiovascular event > 5%)
  • Patients with emphysema confirmed by imaging test
  • patients with obesity BMI > 35 kg / m2

Treatment and study plan

Alveolar recruitment maneuver

Other

The two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O.

Primary outcomes

  1. the change of Atelectasis volume

    Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

    electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)

Secondary outcomes

  1. the change of lung compliance value

    Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

    comparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver

  2. the change of arterial blood gas analysis

    Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

    comparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver

  3. the change of driving pressure value

    Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

    comparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver

  4. the change of peak pressure value

    Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

    comparison peak pressure (cmH2O) before/after recruitment maneuver

  5. The difference of atelectasis

    Time frame: at postoperative 30 minutes

    atelectasis score by lung ultrasonography (score range 0~36)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Comparison of Ventilator-driven Alveolar Maneuver in Laparoscopic Surgery； Tidal Volume Controlled vs Positive End Expiratory Pressure Controlled Cycling Maneuvers； a Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Nov 10, 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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