Clinical trial NCT03157479: Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery
Official title: Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgery--Complications
Keywords: Mechanical ventilation
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.

Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
* Obesity with body mass index\>35 kg/m\^2
* written informed consent

Exclusion Criteria:

* Clinical history or signs of chronic heart failure
* history of neuromuscular disease
* history of thoracic surgery
* pregnancy
* chronic respiratory failure requiring long-term oxygen administration

Primary outcomes:
measure: Postoperative oxygenation
timeFrame: One hour after extubation
Secondary outcomes:
measure: Postoperative forced expiratory volume in 1 second (FEV1)
timeFrame: 48 hours after the end of surgery
measure: Postoperative forced vital capacity (FVC)
timeFrame: 48 hours after the end of surgery
measure: Postoperative Tiffeneau index
timeFrame: 48 hours after the end of surgery
measure: Postoperative Dyspnea
timeFrame: 1 hour after surgery
measure: Pulmonary infection
timeFrame: 24 hours after the end of surgery
measure: Postoperative pulmonary infiltrates
timeFrame: 24 hours after the end of surgery
measure: Intraoperative driving pressure
timeFrame: during surgery, recorded on a 60-minute basis
measure: Intraoperative lung driving pressure
timeFrame: during surgery, recorded on a 60-minute basis
measure: Intraoperative oxygenation
timeFrame: during surgery, recorded on a 60-minute basis
measure: Intraoperative dead space
timeFrame: during surgery, recorded on a 60-minute basis
measure: Lung recruitment
timeFrame: during surgery, recorded on a 60-minute basis
measure: Intraoperative blood pressure
timeFrame: during surgery, recorded on a 60-minute basis
measure: Intraoperative respiratory system compliance
timeFrame: during surgery, recorded on a 60-minute basis
measure: Intraoperative lung compliance
timeFrame: during surgery, recorded on a 60-minute basis
Other outcomes:
Locations:
city: Rome
country: Italy
facility: General surgery OR, A. Gemelli hospital
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Massimo Antonelli, MD
role: PRINCIPAL_INVESTIGATOR
References: