Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03868319

Acronym

LPV-RARC

Enrollment

258

Registered

2019-03-11

Start date

2017-01-01

Completion date

2019-02-28

Last updated

2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung-protective Ventilation

Keywords

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

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.

Interventions

PROCEDURElung protective ventilation strategy

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

PROCEDUREnonprotective ventilation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Investigators, surgeons and patients remained unware of study-group assignments so as to preserve the double blinding.

Intervention 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

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* scheduled for elective RARC

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026