Thoraric SurgeryiPROVE-OLVNCT03182062
Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation
A study testing Alveolar recruitment maneuver, PEEP Titration Trial and Lung protective ventilation in people with Thoraric Surgery and Surgery Time Expected More Than Two Hours, run by Fundación para la Investigación del Hospital Clínico de Valencia at 4 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoraric Surgery, Surgery Time Expected More Than Two Hours
- What is being tested?
- Alveolar recruitment maneuver, PEEP Titration Trial and Lung protective ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 4 sitesSpain
- Study dates
- 8 Sep 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned thoracic surgery > 2 hours.
- Signed informed consent for participation in the study.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Jaume Canet, MD, PhD
Jaume Canet, MD, PhD
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Carmen Unzueta, MD, PhD
Carmen Unzueta, MD, PhD
- Recruiting
Hospital Gregorio Marañón
Madrid, 28007
Ignacio Garutti
Ignacio Garutti, MD, PhD
- Recruiting
Hospital clínico universitario
Valencia, 46010
Carlos Ferrando, MD, PhD, 609892732, cafeoranestesia@gmail.com
About this study
Official title: 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).
- Being tested
- Alveolar recruitment maneuver, PEEP Titration Trial, Lung protective ventilation
- Keywords
- one lung ventilation, postoperative pulmonary complication, perioperative lung protective ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitment maneuverProcedure or surgery
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.)
PEEP Titration TrialProcedure or surgery
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.
Lung protective ventilationProcedure or surgery
Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Alveolar recruitment maneuver; Procedure: 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. Receives: Procedure: Lung protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of postoperative pulmonary complications
composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.
Measured: Up to 7 postoperative days
Secondary outcomes (3)
Reduction of composite of postoperative pulmonary complications
suspicion of pulmonary infection, mild acute respiratory failure, severe respiratory failure, acute respiratory distress syndrome
Measured: 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.
Measured: Up to 7 and 30 postoperative days
Intensive care unit and hospital length of stay reduction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start8 Sep 2018
- Primary completionJan 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thoraric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- Javier Belda, MD, PhD, Study director, Department of Anesthesia and Critical Care; Hospital Clinico Universitario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182062
- Sponsor's protocol ID
- iPROVE-OLV
- Acronym
- iPROVE-OLV
- Status last verified
- Oct 2018
- First submitted
- 25 May 2017
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24557111Fleisher 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.
PubMed 25313335Licker 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.
PubMed 16631680Zorrilla-Vaca A, Zapata-Pena DA, Allen MB, Linares M, Sanahuja P, Librero J, Ferrando C; iPROVE Study Group Collaborators. Intraoperative corticosteroid administration and postoperative pulmonary complications: a secondary analysis of the iPROVE clinical trials. Br J Anaesth. 2026 Aug 27:S0007-0912(26)00583-0. doi: 10.1016/j.bja.2026.08.001. Online ahead of print.
PubMed 42660722Zorrilla-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. 2026 May 1;43(5):395-404. doi: 10.1097/EJA.0000000000002271. Epub 2025 Sep 3.
PubMed 40905246Mazzinari 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.
PubMed 39893063Ferrando 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.
PubMed 38065200
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial
- ClinicalTrials.gov ID
- NCT03182062
- Acronym / sponsor ID
- iPROVE-OLV / iPROVE-OLV
- Keywords
- one lung ventilation, postoperative pulmonary complication, perioperative lung protective ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 8 Sep 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLA-iHFNC | Active comparator | Procedure: Alveolar recruitment maneuver, Procedure: PEEP Titration TrialIntraoperatively 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. |
| STD-O2 | Active comparator | Procedure: Lung protective ventilationIntraoperatively 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned thoracic surgery > 2 hours.
- Signed informed consent for participation in the study.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar recruitment maneuverTo 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 or surgery | OLA-iHFNC |
| PEEP Titration TrialThe 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. | Procedure or surgery | OLA-iHFNC |
| Lung protective ventilationVentilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial. | Procedure or surgery | STD-O2 |
Primary outcome
Reduction of postoperative pulmonary complications
Time frame: Up to 7 postoperative days
composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.
3 secondary outcomes
Reduction of composite of postoperative pulmonary complications
Time frame: Up to 30 postoperative days
Reduction of composite of postoperative complications
Time frame: Up to 7 and 30 postoperative days
Intensive care unit and hospital length of stay reduction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Results publication: PubMed 24557111Ferrando 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.
- Results publication: PubMed 25313335Fleisher 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.
- Results publication: PubMed 16631680Licker 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.
- Derived from this study: PubMed 42660722Zorrilla-Vaca A, Zapata-Pena DA, Allen MB, Linares M, Sanahuja P, Librero J, Ferrando C; iPROVE Study Group Collaborators. Intraoperative corticosteroid administration and postoperative pulmonary complications: a secondary analysis of the iPROVE clinical trials. Br J Anaesth. 2026 Aug 27:S0007-0912(26)00583-0. doi: 10.1016/j.bja.2026.08.001. Online ahead of print.
- Derived from this study: PubMed 40905246Zorrilla-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. 2026 May 1;43(5):395-404. doi: 10.1097/EJA.0000000000002271. Epub 2025 Sep 3.
- Derived from this study: PubMed 39893063Mazzinari 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.
- Derived from this study: PubMed 38065200Ferrando 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Belda, MD, PhD study director
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar recruitment maneuver, PEEP Titration Trial and Lung protective ventilation in people with Thoraric Surgery and Surgery Time Expected More Than Two Hours, run by Fundación para la Investigación del Hospital Clínico de Valencia at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Ferrando, MD, PhD (609892732, cafeoranestesia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of postoperative pulmonary complications (time frame: Up to 7 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182062, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.