Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery

NCT03157479 — Not applicable, Completed, 60 participants, Catholic University of the Sacred Heart

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

Registry	NCT03157479, acronym Inprove4large
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Actual)
Sponsor	Catholic University of the Sacred Heart (Other)
Conditions	Anesthesia, Surgery--Complications
Interventions	Intravenous anesthetic, Crystalloid Solutions, Esophageal pressure measurement, Lung volume measurement with the nitrogen washin-washout technique (Drug, diagnostic test)
Dates	start 2017-05-01, primary completion 2019-03-31, completion 2019-03-31, first posted 2017-05-17, last updated 2019-05-20
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Protective ventilation	Experimental	Drug: Intravenous anesthetic; Drug: Crystalloid Solutions; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Lung volume measurement with the nitrogen washin-washout technique	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.
Standard Ventilation	Active comparator	Drug: Intravenous anesthetic; Drug: Crystalloid Solutions; Diagnostic Test: Esophageal pressure measurement; Diagnostic Test: Lung volume measurement with the nitrogen washin-washout technique	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

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.

+Outcome measures

Primary outcomes

Postoperative oxygenation [One hour after extubation]: PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%

Secondary outcomes

Postoperative forced expiratory volume in 1 second (FEV1) [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
Postoperative forced vital capacity (FVC) [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
Postoperative Tiffeneau index [48 hours after the end of surgery]: computed as FEV1/FVC
Postoperative Dyspnea [1 hour after surgery]: Dyspnea assessed by Borg dyspnea scale
Pulmonary infection [24 hours after the end of surgery]: modified clinical pulmonary infection score (mCPIS)
Postoperative pulmonary infiltrates [24 hours after the end of surgery]: Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment
Intraoperative driving pressure [during surgery, recorded on a 60-minute basis]: driving pressure, computed as Plateau pressure-PEEP
Intraoperative lung driving pressure [during surgery, recorded on a 60-minute basis]: transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure
Intraoperative oxygenation [during surgery, recorded on a 60-minute basis]: PaO2/FiO2
Intraoperative dead space [during surgery, recorded on a 60-minute basis]: Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
Lung recruitment [during surgery, recorded on a 60-minute basis]: lung recruitment/changes in end expiratory lung volume between the two groups
Intraoperative blood pressure [during surgery, recorded on a 60-minute basis]: Arterial blood pressure
Intraoperative respiratory system compliance [during surgery, recorded on a 60-minute basis]: computed as Tidal volume/airway driving pressure
Intraoperative lung compliance [during surgery, recorded on a 60-minute basis]: computed as Tidal volume/lung driving pressure

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
General surgery OR, A. Gemelli hospital	Rome	Italy

+Publications

Results publication: 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

+Investigators

Massimo Antonelli, MD, Principal investigator, Catholic University of the Sacred Heart

My Notes

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