Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

Lung-protective Ventilation Clinical Trial

— LPV-RARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868319
• Other study ID #: Da vinci
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: February 28, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• scheduled for elective RARC

Exclusion Criteria:

• history of lung surgery

• patients' refusal or inability to give informed consent

Related Conditions & MeSH terms

• Lung-protective Ventilation

Intervention

Procedure:
• lung protective ventilation strategy
low tidal volumes and positive end-expiratory pressure mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer
• nonprotective ventilation
large tidal volume and zero PEEP mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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