Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

NCT ID: NCT03868319

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-02-28

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.

Conditions

Lung-protective Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

control group

nonprotective ventilation with a tidal volume of 9 ml kg-1 PBW with ZEEP

Group Type: EXPERIMENTAL

nonprotective ventilation

Intervention Type: PROCEDURE

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

LPV group

a tidal volume of 6 ml kg-1 PBW with a 7 cmH2O level PEEP

Group Type: EXPERIMENTAL

lung protective ventilation strategy

Intervention Type: PROCEDURE

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

Interventions

lung protective ventilation strategy

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

Intervention Type: PROCEDURE

nonprotective ventilation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• scheduled for elective RARC

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

DAN HUANG

Principal Investigator, clinical attending in anesthesia department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Xie, PhD

Role: STUDY_CHAIR

The Second Affiliated Hospital of Soochow University, China

Locations

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

Da vinci

Identifier Type: -

Identifier Source: org_study_id