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Completed

NCT Number: NCT03868319

Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

Robot-assisted laparoscopic radical cystectomy (RARC) increases the incidence of postoperative complications. We conducted a study to determine the effect of lung-protective ventilation strategy.

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Key information

Conditions

Lung-protective Ventilation

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

Robot-assisted laparoscopic radical cystectomy (RARC) performed with patient in the steep Trendelenburg position under pneumoperitoneum increases the incidence of postoperative complications. Approach termed lung-protective ventilation (LPV) strategy which refers to the use of low tidal volumes and positive end-expiratory pressure (PEEP) may lead to a reduction in inflammation and prevent the occurrence of atelectasis. Computed tomography (CT) requiring transportation is the golden standard for measuring atelectasis, which is not suitable for perioperative observation. Lung ultrasound (LUS) which is noninvasive and easily repeatable at the bedside appears to be an accurate diagnostic tool for early detection of atelectasis. Thus, we conducted the trial to determine whether an LPV strategy has benefits in patients scheduled for RARC through a multifaceted method. We hypothesized that the use of prophylactic low tidal volume and PEEP would decrease postoperative inflammation and atelectasis, thereby, improve outcomes, as compared with the standard of nonprotective mechanical ventilation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • scheduled for elective RARC

Exclusion criteria

  • history of lung surgery
  • patients' refusal or inability to give informed consent

Treatment and study plan

lung protective ventilation strategy

Procedure

low tidal volumes and positive end-expiratory pressure mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer

nonprotective ventilation

Procedure

large tidal volume and zero PEEP mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer

Primary outcomes

  1. occurrence of postoperative pulmonary complications (PPCs)

    Time frame: during the first 90 days after surgery

    graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications)

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Effect of Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy on Postoperative Pulmonary Complication

Acronym: LPV-RARC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Mar 27, 2019

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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