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Completed

NCT Number: NCT04327193

Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries

The purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (PEEP) titration.

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Key information

Conditions

Atelectasis, Postoperative Pulmonary Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing robot-assisted laparoscopic prostatectomy with Trendelenburg position

Exclusion criteria

  • American Society of Anesthesiologists physical status IV or more
  • Severe cardiovascular disease
  • Severe chronic obstructive pulmonary disease, emphysema
  • History of pneumothorax, bullae
  • History of lung resection surgery
  • Conversion to laparotomy
  • Refusal to participate

Treatment and study plan

Titrated PEEP based on driving pressure

Procedure

Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.

Conventional PEEP

Procedure

Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.

Primary outcomes

  1. Modified lung ultrasound score

    Time frame: 30 minutes after PACU administration

    The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.

Secondary outcomes

  1. Modified lung ultrasound score

    Time frame: Intraoperative (at the end of operation before emergence)

    The score is calculated by adding up the 12 individual part scores assessed using lung ultrasound. The score for each part ranges from 0 to 3.

  2. Incidence of intraoperative desaturation

    Time frame: Intraoperative

    Oxygen saturation by pulse oximetry< 95%

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

    Time frame: Intraoperative (30 minutes after designated PEEP applied)

    Partial pressure of arterial oxygen/fraction of inspired oxygen ratio

  4. Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio

    Time frame: 30 minutes after PACU administration

    Partial pressure of arterial oxygen/fraction of inspired oxygen ratio

  5. Postoperative pulmonary complications

    Time frame: After operation~ postoperative day 3

    Extubation failure, Fever, respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effectiveness of Driving Pressure Based Ventilation Strategy in Robot-assisted Laparoscopic Surgeries With Steep Trendelenburg Position: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Oct 15, 2021

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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