Skip to main content
OpenTrials
Completed

NCT Number: NCT03157479

Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Surgery--Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General surgery OR, A. Gemelli hospital

Rome, 00100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous anesthetic

Drug

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

Drug

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

Esophageal pressure measurement

Diagnostic Test

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

Diagnostic Test

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.

Primary outcomes

  1. Postoperative oxygenation

    Time frame: One hour after extubation

    PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%

Secondary outcomes

  1. Postoperative forced expiratory volume in 1 second (FEV1)

    Time frame: 48 hours after the end of surgery

    volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity

  2. Postoperative forced vital capacity (FVC)

    Time frame: 48 hours after the end of surgery

    the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity

  3. Postoperative Tiffeneau index

    Time frame: 48 hours after the end of surgery

    computed as FEV1/FVC

  4. Postoperative Dyspnea

    Time frame: 1 hour after surgery

    Dyspnea assessed by Borg dyspnea scale

  5. Pulmonary infection

    Time frame: 24 hours after the end of surgery

    modified clinical pulmonary infection score (mCPIS)

  6. Postoperative pulmonary infiltrates

    Time frame: 24 hours after the end of surgery

    Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment

  7. Intraoperative driving pressure

    Time frame: during surgery, recorded on a 60-minute basis

    driving pressure, computed as Plateau pressure-PEEP

  8. Intraoperative lung driving pressure

    Time frame: during surgery, recorded on a 60-minute basis

    transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure

  9. Intraoperative oxygenation

    Time frame: during surgery, recorded on a 60-minute basis

    PaO2/FiO2

  10. Intraoperative dead space

    Time frame: during surgery, recorded on a 60-minute basis

    Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2

  11. Lung recruitment

    Time frame: during surgery, recorded on a 60-minute basis

    lung recruitment/changes in end expiratory lung volume between the two groups

  12. Intraoperative blood pressure

    Time frame: during surgery, recorded on a 60-minute basis

    Arterial blood pressure

  13. Intraoperative respiratory system compliance

    Time frame: during surgery, recorded on a 60-minute basis

    computed as Tidal volume/airway driving pressure

  14. Intraoperative lung compliance

    Time frame: during surgery, recorded on a 60-minute basis

    computed as Tidal volume/lung driving pressure

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Acronym: Inprove4large

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.