Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy (LPV-RARC)

Shanghai Jiao Tong University

Status: Completed

Conditions: Lung-protective Ventilation

Treatments: Procedure: nonprotective ventilation; Procedure: lung protective ventilation strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03868319

Da vinci

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for elective RARC

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 2 patient groups

control group

Experimental group

Description:

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

Treatment:

Procedure: nonprotective ventilation

LPV group

Experimental group

Description:

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

Treatment:

Procedure: lung protective ventilation strategy