Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lung-protective Ventilation

Intervention / Treatment
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* Procedure: lung protective ventilation strategy
* Procedure: nonprotective ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for elective RARC Exclusion Criteria: history of lung surgery patients' refusal or inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Lung-protective ventilation(LPV) group (low tidal volume 6 ml kg-1 predicted ideal body weight (PBW)+ 7 cmH2O positive end-expiratory pressure(PEEP)) vs. nonprotective group (control group) (large tidal volume 9 ml kg-1 + zero PEEP (ZEEP)) mechanical ventilation in patients undergoing RARC
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>nonprotective ventilation with a tidal volume of 9 ml kg-1 PBW with ZEEP | Procedure: nonprotective ventilation<br>* large tidal volume and zero PEEP mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer<br>|
| Experimental: LPV group<br>a tidal volume of 6 ml kg-1 PBW with a 7 cmH2O level PEEP | Procedure: lung protective ventilation strategy<br>* low tidal volumes and positive end-expiratory pressure mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of postoperative pulmonary complications (PPCs) | graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications) | during the first 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung-protective ventilation strategy, low tidal volume, positive end-expiratory pressure, Lung ultrasound, postoperative pulmonary complications