NCT02776046

Brief Summary

The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.

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
756

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

May 15, 2016

Last Update Submit

February 23, 2018

Conditions

HyperoxiaPostoperative ComplicationSurgical Site Infection

Keywords

Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    seven postoperative days

Secondary Outcomes (3)

  • Systemic complications

    seven postoperative days

  • Pulmonary complications

    seven postoperative days

  • Systemic and pulmonary complications

    thirty postoperative days

Study Arms (2)

High FiO2

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. Postoperatively 3h with 0.8 FiO2 and individualized CPAP

Drug: High FiO2

Conventional FiO2

ACTIVE COMPARATOR

Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.3. 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 3h with 0.3 FiO2 and individualized CPAP

Drug: Conventional FiO2

Interventions

High FiO2DRUG

High FiO2 with a perioperative open lung strategy

High FiO2
Conventional FiO2DRUG

Conventional FiO2 with a perioperative open lung strategy

Conventional FiO2

Eligibility Criteria

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

You may qualify if:

  • Age not less than 18
  • 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 (1)

Department of Anesthesia and Critical Care; Hospital Clinico Universitario

Valencia, 46010, Spain

RECRUITING

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

  • Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.

    PMID: 16249417BACKGROUND

  • Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.

    PMID: 19826023BACKGROUND

  • Greif R, Akca O, Horn EP, Kurz A, Sessler DI; Outcomes Research Group. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. N Engl J Med. 2000 Jan 20;342(3):161-7. doi: 10.1056/NEJM200001203420303.

    PMID: 10639541BACKGROUND

  • 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

  • Ferrando C, Aldecoa C, Unzueta C, Belda FJ, Librero J, Tusman G, Suarez-Sipmann F, Peiro S, Pozo N, Brunelli A, Garutti I, Gallego C, Rodriguez A, Garcia JI, Diaz-Cambronero O, Balust J, Redondo FJ, de la Matta M, Gallego-Ligorit L, Hernandez J, Martinez P, Perez A, Leal S, Alday E, Monedero P, Gonzalez R, Mazzirani G, Aguilar G, Lopez-Baamonde M, Felipe M, Mugarra A, Torrente J, Valencia L, Varon V, Sanchez S, Rodriguez B, Martin A, India I, Azparren G, Molina R, Villar J, Soro M; iPROVE-O2 Network. Effects of oxygen on post-surgical infections during an individualised perioperative open-lung ventilatory strategy: a randomised controlled trial. Br J Anaesth. 2020 Jan;124(1):110-120. doi: 10.1016/j.bja.2019.10.009. Epub 2019 Nov 22.

    PMID: 31767144DERIVED

  • Ferrando C, Soro M, Unzueta C, Canet J, Tusman G, Suarez-Sipmann F, Librero J, Peiro S, Pozo N, Delgado C, Ibanez M, Aldecoa C, Garutti I, Pestana D, Rodriguez A, Garcia Del Valle S, Diaz-Cambronero O, Balust J, Redondo FJ, De La Matta M, Gallego L, Granell M, Martinez P, Perez A, Leal S, Alday K, Garcia P, Monedero P, Gonzalez R, Mazzinari G, Aguilar G, Villar J, Belda FJ; iPROVE-O2 Network Group. Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 31;7(7):e016765. doi: 10.1136/bmjopen-2017-016765.

    PMID: 28760799DERIVED

MeSH Terms

Conditions

HyperoxiaPostoperative ComplicationsSurgical Wound Infection

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesWound InfectionInfections

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
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

May 15, 2016

First Posted

May 18, 2016

Study Start

June 1, 2017

Primary Completion

November 1, 2018

Study Completion

February 1, 2019

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

ES(1)