Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

NCT03868319 | Completed

• 1 other identifier: Da vinci
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung-protective Ventilation

Keywords

lung-protective ventilation strategy; low tidal volume; positive end-expiratory pressure; Lung ultrasound; postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control group

EXPERIMENTAL

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

Procedure: nonprotective ventilation

LPV group

EXPERIMENTAL

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

Procedure: lung protective ventilation strategy

Interventions

lung protective ventilation strategy PROCEDURE

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

LPV group

nonprotective ventilation PROCEDURE

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

control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for elective RARC

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Study Officials

• Hong Xie, PhD

  The Second Affiliated Hospital of Soochow University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, surgeons and patients remained unware of study-group assignments so as to preserve the double blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, clinical attending in anesthesia department

Model Details: 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

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: January 1, 2017
• Primary Completion: January 30, 2019
• Study Completion: February 28, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

CN (1)