Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

Anesthesia Clinical Trial

— Inprove4large  

Official title:

Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157479
• Other study ID #: InproveForLarge
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2019
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Surgery--Complications

Intervention

Drug:
• Intravenous anesthetic
Anaesthesia induction will be obtained with i.v. 2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium. Anaesthesia will be maintained with i.v. propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
• Crystalloid Solutions
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h. Treatment of eventual hemodynamic instability will be left to the attending physician

Diagnostic Test:
• Esophageal pressure measurement
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
• Lung volume measurement with the nitrogen washin-washout technique
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.

Locations

Country	Name	City	State
Italy	General surgery OR, A. Gemelli hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative oxygenation	PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%	One hour after extubation
Secondary	Postoperative forced expiratory volume in 1 second (FEV1)	volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity	48 hours after the end of surgery
Secondary	Postoperative forced vital capacity (FVC)	the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity	48 hours after the end of surgery
Secondary	Postoperative Tiffeneau index	computed as FEV1/FVC	48 hours after the end of surgery
Secondary	Postoperative Dyspnea	Dyspnea assessed by Borg dyspnea scale	1 hour after surgery
Secondary	Pulmonary infection	modified clinical pulmonary infection score (mCPIS)	24 hours after the end of surgery
Secondary	Postoperative pulmonary infiltrates	Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment	24 hours after the end of surgery
Secondary	Intraoperative driving pressure	driving pressure, computed as Plateau pressure-PEEP	during surgery, recorded on a 60-minute basis
Secondary	Intraoperative lung driving pressure	transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure	during surgery, recorded on a 60-minute basis
Secondary	Intraoperative oxygenation	PaO2/FiO2	during surgery, recorded on a 60-minute basis
Secondary	Intraoperative dead space	Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2	during surgery, recorded on a 60-minute basis
Secondary	Lung recruitment	lung recruitment/changes in end expiratory lung volume between the two groups	during surgery, recorded on a 60-minute basis
Secondary	Intraoperative blood pressure	Arterial blood pressure	during surgery, recorded on a 60-minute basis
Secondary	Intraoperative respiratory system compliance	computed as Tidal volume/airway driving pressure	during surgery, recorded on a 60-minute basis
Secondary	Intraoperative lung compliance	computed as Tidal volume/lung driving pressure	during surgery, recorded on a 60-minute basis