NCT03182062

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 8, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

May 25, 2017

Last Update Submit

October 1, 2018

Conditions

Thoraric SurgerySurgery Time Expected More Than Two Hours

Keywords

one lung ventilationpostoperative pulmonary complicationperioperative lung protective ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Reduction of composite of postoperative pulmonary complications

    Up to 30 postoperative days

  • Reduction of composite of postoperative complications

    Up to 7 and 30 postoperative days

  • Intensive care unit and hospital length of stay reduction

    1 year

Study Arms (2)

OLA-iHFNC

ACTIVE COMPARATOR

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 maneuverProcedure: PEEP Titration Trial

STD-O2

ACTIVE COMPARATOR

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

Interventions

Alveolar recruitment maneuverPROCEDURE

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.)

OLA-iHFNC
PEEP Titration TrialPROCEDURE

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.

OLA-iHFNC
Lung protective ventilationPROCEDURE

Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.

STD-O2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08026, Spain

RECRUITING

Hospital Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital clínico universitario

Valencia, 46010, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 24557111RESULT

  • 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.

    PMID: 25313335RESULT

  • 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.

    PMID: 16631680RESULT

  • Zorrilla-Vaca A, Barbeta E, Librero J, Ferrando C; iPROVE-OLV Research Network Group. Open-lung ventilation and mechanical power in thoracic surgery: Post hoc analysis of a multicentre randomised trial. Eur J Anaesthesiol. 2025 Sep 4. doi: 10.1097/EJA.0000000000002271. Online ahead of print.

    PMID: 40905246DERIVED

  • Mazzinari G, Diaz-Cambronero O, Garutti I, Errando CL, Ferrando C; iPROVE-OLV investigators. Impact of neuromuscular block monitoring and reversal on postoperative pulmonary complications in thoracic surgery: a Bayesian analysis of the iPROVE-OLV trial. Br J Anaesth. 2025 Nov;135(5):1428-1440. doi: 10.1016/j.bja.2024.11.041. Epub 2025 Feb 1.

    PMID: 39893063DERIVED

  • Ferrando C, Carraminana A, Pineiro P, Mirabella L, Spadaro S, Librero J, Ramasco F, Scaramuzzo G, Cervantes O, Garutti I, Parera A, Argilaga M, Herranz G, Unzueta C, Vives M, Regi K, Costa-Reverte M, Sonsoles Leal M, Nieves-Alonso J, Garcia E, Rodriguez-Perez A, Farina R, Cabrera S, Guerra E, Gallego-Ligorit L, Herrero-Izquierdo A, Valles-Torres J, Ramos S, Lopez-Herrera D, De La Matta M, Gokhan S, Kucur E, Mugarra A, Soro M, Garcia L, Sastre JA, Aguirre P, Salazar CJ, Ramos MC, Morocho DR, Trespalacios R, Ezequiel-Fernandez F, Lamanna A, Pia Cantatore L, Laforgia D, Bellas S, Lopez C, Navarro-Ripoll R, Martinez S, Vallverdu J, Jacas A, Yepes-Temino MJ, Belda FJ, Tusman G, Suarez-Sipmann F, Villar J; iPROVE-OLV Research Network Group. Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV): a multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2024 Mar;12(3):195-206. doi: 10.1016/S2213-2600(23)00346-6. Epub 2023 Dec 5.

    PMID: 38065200DERIVED

Study Officials

  • Javier Belda, MD, PhD

    Department of Anesthesia and Critical Care; Hospital Clinico Universitario

    STUDY DIRECTOR

Central Study Contacts

Carlos Ferrando, MD, PhD

CONTACT

609892732cafeoranestesia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigador

Study Record Dates

First Submitted

May 25, 2017

First Posted

June 9, 2017

Study Start

September 8, 2018

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations

ES(4)