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Individualized Perioperative Open Lung Ventilatory Strategy (iPROVE)

Primary Purpose

Moderated-high Risk of Postoperative Pulmonary Complication, Abdominal Surgery Expected More Than Two Hours

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Alveolar recruitment maneuver

Calculation of optimal PEEP

Postoperative CPAP

About this trial

This is an interventional prevention trial for Moderated-high Risk of Postoperative Pulmonary Complication focused on measuring ventilation, lung, lung complications, postoperative complications, perioperative lung protective ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age not less than 18
Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score> 44 points define a high risk, included in the Information Booklet Investigator).
Planned abdominal 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.

Sites / Locations

Massachusetts General Hospital
Hospital Privado de la Comunidad
Hospital Germans Trias i Pujol
Hospital de la Santa Creu i Sant Pau
Hospital Gregorio Marañón
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Individualized ventilation

Individualized vent. + postop. CPAP

Standard ventilation

Standard vent. + postoperative CPAP

Arm Description

Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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.

Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (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 a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.

Intraoperatively ventilated patients with a tidal volume of 8 ml / kg of ideal body weight, PEEP 6 cmH2O and FiO2 0.8. In these groups no recruitment maneuvers or optimal PEEP setting will be performed. Postoperatively, a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.

Outcomes

Primary Outcome Measures

Reduction of lung and systemic postoperative complications

Secondary Outcome Measures

Reduction of lung and systemic postoperative complications

Full Information

NCT ID

NCT02158923

First Posted

June 5, 2014

Last Updated

May 14, 2016

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

Hospital de Manises, Hospital General Valencia, Hospital Universitario La Fe, Germans Trias i Pujol Hospital, Hospital de Sant Pau, Hospital del Mar, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital General Universitario Gregorio Marañon, Hospital General Universitario de Alicante, Hospital Juan Canalejo, Hospital General Regional de León, Hospital Universitario Virgen de la Arrixaca, Hospital Miguel Servet, Hospital Clínico Universitario de Valladolid, Hospital Universitario Fundación Alcorcón, Hospital General de Ciudad Real, Hospital Universitario de Valme, Hospital de Basurto, Hospital Dr. Negrín, Hospital de Galdakano, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Puerta de Hierro University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02158923

Brief Title

Individualized Perioperative Open Lung Ventilatory Strategy

Acronym

iPROVE

Official Title

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderated-high Risk of Postoperative Pulmonary Complication, Abdominal Surgery Expected More Than Two Hours

Keywords

ventilation, lung, lung complications, postoperative complications, perioperative lung protective ventilation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

920 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individualized ventilation

Arm Type

Experimental

Arm Description

Arm Title

Individualized vent. + postop. CPAP

Arm Type

Experimental

Arm Description

Arm Title

Standard ventilation

Arm Type

No Intervention

Arm Description

Arm Title

Standard vent. + postoperative CPAP

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Alveolar recruitment maneuver

Intervention Description

To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)

Intervention Type

Procedure

Intervention Name(s)

Calculation of optimal PEEP

Intervention Description

Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .

Intervention Type

Procedure

Intervention Name(s)

Postoperative CPAP

Intervention Description

Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.

Primary Outcome Measure Information:

Title

Reduction of lung and systemic postoperative complications

Time Frame

Up to 7 postoperative days

Secondary Outcome Measure Information:

Title

Reduction of lung and systemic postoperative complications

Time Frame

Up to 30 postoperative days

Other Pre-specified Outcome Measures:

Title

Mortality evaluation

Time Frame

180 and 365 days postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age not less than 18 Risk of postoperative pulmonary complication moderate-high defined by a score ≥ 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score> 44 points define a high risk, included in the Information Booklet Investigator). Planned abdominal 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Ferrando, MD, PhD

Organizational Affiliation

Hospital Clínico Universitario Valencia

Official's Role

Study Director

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

MA 02114

Country

United States

Facility Name

Hospital Privado de la Comunidad

City

Mar de Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Hospital Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

08026

Country

Spain

Facility Name

Hospital Gregorio Marañón

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Uppsala University Hospital

City

Uppsala

State/Province

Uppland

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

23902482

Citation

Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

Results Reference

background

PubMed Identifier

24894577

Citation

PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.

Results Reference

background

PubMed Identifier

23093163

Citation

Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.

Results Reference

background

PubMed Identifier

34460936

Citation

Ferrando C, Librero J, Tusman G, Serpa-Neto A, Villar J, Belda FJ, Costa E, Amato MBP, Suarez-Sipmann F; iPROVE Network Group. Intraoperative open lung condition and postoperative pulmonary complications. A secondary analysis of iPROVE and iPROVE-O2 trials. Acta Anaesthesiol Scand. 2022 Jan;66(1):30-39. doi: 10.1111/aas.13979. Epub 2021 Sep 22.

Results Reference

derived

PubMed Identifier

32028288

Citation

Garutti I, Errando CL, Mazzinari G, Bellon JM, Diaz-Cambronero O, Ferrando C; iPROVE network. Spontaneous recovery of neuromuscular blockade is an independent risk factor for postoperative pulmonary complications after abdominal surgery: A secondary analysis. Eur J Anaesthesiol. 2020 Mar;37(3):203-211. doi: 10.1097/EJA.0000000000001128.

Results Reference

derived

PubMed Identifier

29371130

Citation

Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.

Results Reference

derived

PubMed Identifier

25927183

Citation

Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1.

Results Reference

derived

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Individualized Perioperative Open Lung Ventilatory Strategy

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