Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation (iPROVE-OLV)

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial

The purpose of this study is to determine whether individualized ventilatory management during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, ICU and hospital length of stay compared to a standardized Lung Protective Ventilation (LPV).

Study Overview

• Status: Unknown
• Conditions: Thoraric Surgery; Surgery Time Expected More Than Two Hours
• Intervention / Treatment: Procedure: Alveolar recruitment maneuver; Procedure: PEEP Titration Trial; Procedure: Lung protective ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: carlos ferrando, MD, PhD; Phone Number: 609892732; Email: cafeoranestesia@gmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08026
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Carmen Unzueta, MD, PhD
    • Principal Investigator: Carmen Unzueta, MD, PhD
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital Gregorio Marañón
    • Contact: Ignacio Garutti
    • Principal Investigator: Ignacio Garutti, MD, PhD
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario
    • Contact: carlos ferrando, MD, PhD; Phone Number: 609892732; Email: cafeoranestesia@gmail.com
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Hospital Germans Trias i Pujol
      • Contact: Jaume Canet, MD, PhD
      • Principal Investigator: Jaume Canet, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Planned thoracic surgery > 2 hours.
• Signed informed consent for participation in the study.

Exclusion Criteria:

• Age less than 18 years.
• Pregnant or breast-feeding.
• Patients with BMI >35.
• Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.
• Heart failure: NYHA IV.
• Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support.
• Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg).
• Mechanical ventilation in the last 15 days.
• Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
• Patient with preoperatively CPAP.
• Participation in another experimental protocol at the time of intervention selection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OLA-iHFNC; Intraoperatively ventilated patients with a tidal volume (VT) of 5-6ml / kg of ideal body weight and respiratory rate to maintain normal carbon dioxide. After intubation, in all patients will be performed an alveolar recruitment maneuver (MRA) and a PEEP titration trial (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed. Postoperatively, high flow oxygen therapy will be individually indicated by evaluating peripheral oxygen saturation.	Procedure: Alveolar recruitment maneuver; To start the Alveolar Recruitment Maneuver (ARM) the ventilatory mode will be changed to pressure-controlled mode (PCV) with 20 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 5 cmH2O. The PEEP level will be increased in 5 cmH2O steps every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (20 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.); Procedure: PEEP Titration Trial; The ventilation mode will then switch back to volume controlled ventilation with the same baseline settings but with 20 cmH2O PEEP level. Then PEEP will be reduced in 2 cmH2O steps each maintained for 5 breaths the level of PEEP with the best (higher) dynamic compliance.
Active Comparator: STD-O2; Intraoperatively ventilated patients with a tidal volume of 5-6 ml / kg of ideal body weightand respiratory rate to maintain normal carbon dioxide, PEEP 5 cmH2O. In this group no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, standard oxygen therapy.	Procedure: Lung protective ventilation; Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of postoperative pulmonary complications	composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.	Up to 7 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of composite of postoperative pulmonary complications	suspicion of pulmonary infection, mild acute respiratory failure, severe respiratory failure, acute respiratory distress syndrome	Up to 30 postoperative days
Reduction of composite of postoperative complications	Renal failure, cardiac failure, sepsis, septic shock, surgical site infection, urinary infection and other pulmonary complications not included in the primary outcome such as leaks, atelectasis, pleural effusion, empyema, dyspnea.	Up to 7 and 30 postoperative days
Intensive care unit and hospital length of stay reduction		1 year

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Investigators: Study Director: Javier Belda, MD, PhD, Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Publications and helpful links

General Publications

• Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.
• Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014 Oct 7;3:7. doi: 10.1186/2047-0525-3-7. eCollection 2014.
• Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: one lung ventilation; postoperative pulmonary complication; perioperative lung protective ventilation
• Other Study ID Numbers: iPROVE-OLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No