Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

Not Applicable

Completed

• Conditions: Lung-protective Ventilation
• Interventions: Procedure: nonprotective ventilation; Procedure: lung protective ventilation strategy

• Registration Number: NCT03868319
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-02-28
• Status Verified: 2019-03
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• scheduled for elective RARC

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	nonprotective ventilation	nonprotective ventilation with a tidal volume of 9 ml kg-1 PBW with ZEEP
LPV group	lung protective ventilation strategy	a tidal volume of 6 ml kg-1 PBW with a 7 cmH2O level PEEP

Primary Outcome Measures

Name	Time	Method
occurrence of postoperative pulmonary complications (PPCs)	during the first 90 days after surgery	graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications)

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China