NCT02158923

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
920

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
4 countries

7 active sites

Status
completed

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

June 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.6 years

First QC Date

June 5, 2014

Last Update Submit

May 14, 2016

Conditions

Moderated-high Risk of Postoperative Pulmonary ComplicationAbdominal Surgery Expected More Than Two Hours

Keywords

ventilationlunglung complicationspostoperative complicationsperioperative lung protective ventilation

Outcome Measures

Primary Outcomes (1)

  • Reduction of lung and systemic postoperative complications

    Up to 7 postoperative days

Secondary Outcomes (1)

  • Reduction of lung and systemic postoperative complications

    Up to 30 postoperative days

Other Outcomes (1)

  • Mortality evaluation

    180 and 365 days postoperative

Study Arms (4)

Individualized ventilation

EXPERIMENTAL

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.

Procedure: Alveolar recruitment maneuverProcedure: Calculation of optimal PEEP

Individualized vent. + postop. CPAP

EXPERIMENTAL

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.

Procedure: Alveolar recruitment maneuverProcedure: Calculation of optimal PEEPProcedure: Postoperative CPAP

Standard ventilation

NO INTERVENTION

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.

Standard vent. + postoperative CPAP

ACTIVE COMPARATOR

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.

Procedure: Postoperative CPAP

Interventions

Alveolar recruitment maneuverPROCEDURE

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.)

Individualized vent. + postop. CPAPIndividualized ventilation
Calculation of optimal PEEPPROCEDURE

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 .

Individualized vent. + postop. CPAPIndividualized ventilation
Postoperative CPAPPROCEDURE

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.

Individualized vent. + postop. CPAPStandard vent. + postoperative CPAP

Eligibility Criteria

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

You may qualify if:

  • 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.

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 (7)

Massachusetts General Hospital

Boston, Massachusetts, MA 02114, United States

Location

Hospital Privado de la Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08026, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Valencia, Valencia, 46010, Spain

Location

Uppsala University Hospital

Uppsala, Uppland, Sweden

Location

Related Publications (7)

  • 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.

    PMID: 23902482BACKGROUND

  • 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.

    PMID: 24894577BACKGROUND

  • 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.

    PMID: 23093163BACKGROUND

  • 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.

    PMID: 34460936DERIVED

  • 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.

    PMID: 32028288DERIVED

  • 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.

    PMID: 29371130DERIVED

  • 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.

    PMID: 25927183DERIVED

MeSH Terms

Conditions

Respiratory AspirationPostoperative Complications

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos Ferrando, MD, PhD

    Hospital Clínico Universitario Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 9, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

ES(4)AR(1)SE(1)US(1)