Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

NCT ID: NCT03157479

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Protective ventilation

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.

Group Type: EXPERIMENTAL

Intravenous anesthetic

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Standard Ventilation

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

Group Type: ACTIVE_COMPARATOR

Intravenous anesthetic

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Massimo Antonelli

MD, Full Professor, Director of the Department of Anesthesiology and Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Antonelli, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

General surgery OR, A. Gemelli hospital

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 36495775 (View on PubMed)

Other Identifiers

InproveForLarge

Identifier Type: -

Identifier Source: org_study_id