Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

NCT03157479 | Completed

• 1 other identifier: InproveForLarge
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery--Complications

Keywords

Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Postoperative oxygenation

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

  One hour after extubation

Secondary Outcomes (14)

• Postoperative forced expiratory volume in 1 second (FEV1)

  48 hours after the end of surgery

• Postoperative forced vital capacity (FVC)

  48 hours after the end of surgery

• Postoperative Tiffeneau index

  48 hours after the end of surgery

• Postoperative Dyspnea

  1 hour after surgery

• Pulmonary infection

  24 hours after the end of surgery

Study Arms (2)

Protective ventilation

EXPERIMENTAL

Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 10 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period. In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached.

Drug: Intravenous anesthetic; Drug: Crystalloid Solutions; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Lung volume measurement with the nitrogen washin-washout technique

Standard Ventilation

ACTIVE COMPARATOR

Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height \[cm\] -152.4)), FiO2 0.4 and PEEP 5 cmH2O during the whole study period. Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg. I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second

Drug: Intravenous anesthetic; Drug: Crystalloid Solutions; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Lung volume measurement with the nitrogen washin-washout technique

Interventions

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

Protective ventilation; Standard Ventilation

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

Protective ventilation; Standard Ventilation

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

Protective ventilation; Standard Ventilation

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.

Protective ventilation; Standard Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

General surgery OR, A. Gemelli hospital

Rome, 00100, Italy

Location

Related Publications (1)

• Grieco DL, Russo A, Anzellotti GM, Romano B, Bongiovanni F, Dell'Anna AM, Mauti L, Cascarano L, Gallotta V, Rosa T, Varone F, Menga LS, Polidori L, D'Indinosante M, Cappuccio S, Galletta C, Tortorella L, Costantini B, Gueli Alletti S, Sollazzi L, Scambia G, Antonelli M. Lung-protective ventilation during Trendelenburg pneumoperitoneum surgery: A randomized clinical trial. J Clin Anesth. 2023 May;85:111037. doi: 10.1016/j.jclinane.2022.111037. Epub 2022 Dec 7.

  PMID: 36495775 DERIVED

MeSH Terms

Interventions

Anesthetics, Intravenous; Crystalloid Solutions; Lung Volume Measurements

Intervention Hierarchy (Ancestors)

Anesthetics, General; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Massimo Antonelli, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Full Professor, Director of the Department of Anesthesiology and Intensive Care Medicine

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 17, 2017
• Study Start: May 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

IT (1)