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Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). (iPROVE-O2)

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ClinicalTrials.gov Identifier: NCT02776046
Recruitment Status : Unknown
Verified February 2018 by Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia.
Recruitment status was:  Recruiting
First Posted : May 18, 2016
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
Hospital La Fe de Valencia
Hospital General Universitario de Valencia
Hospital de Manises
Hospital de Elche
Hospital de Villajoyosa
Hospital San Pau de Barcelona
Hospital Clinic of Barcelona
Hospital Germans Tríes i Pujol de Badalona
Hospital La Princesa de Madrid
Hospital Gregorio Marañon de Madrid
Hospital Ramón y Cajal de Madrid
Hospital Puerta de Hierro de Majalahonda
Hospital Universitario Fundación Alcorcón
Hospital Virgen del Rocío de Sevilla
Hospital Son Espases de Mallorca
Hospital Dr. Negrin de la Palmas
Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife
Hospital de Leon
Hospital POVISA de Vigo
Hospital Álvaro Cunqueiro de Vigo
Hospital de Albacete
Hospital Principe de Asturias de Madrid
Hospital Miguel Servet de Zaragoza
Hospital General de Ciudad Real
Hospital Río Hortega de Valladolid
Information provided by (Responsible Party):
Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia

Tracking Information
First Submitted Date  ICMJE May 15, 2016
First Posted Date  ICMJE May 18, 2016
Last Update Posted Date February 26, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
Surgical site infection [ Time Frame: seven postoperative days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Systemic complications [ Time Frame: seven postoperative days ]
  • Pulmonary complications [ Time Frame: seven postoperative days ]
  • Systemic and pulmonary complications [ Time Frame: thirty postoperative days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).
Official Title  ICMJE Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Hyperoxia
  • Postoperative Complication
  • Surgical Site Infection
Intervention  ICMJE
  • Drug: High FiO2
    High FiO2 with a perioperative open lung strategy
  • Drug: Conventional FiO2
    Conventional FiO2 with a perioperative open lung strategy
Study Arms  ICMJE
  • Experimental: High FiO2

    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

    Intervention: Drug: High FiO2
  • Active Comparator: Conventional FiO2

    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

    Intervention: Drug: Conventional FiO2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
756
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age not less than 18
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02776046
Other Study ID Numbers  ICMJE iPROVE-O2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia
Study Sponsor  ICMJE Fundación para la Investigación del Hospital Clínico de Valencia
Collaborators  ICMJE
  • Hospital La Fe de Valencia
  • Hospital General Universitario de Valencia
  • Hospital de Manises
  • Hospital de Elche
  • Hospital de Villajoyosa
  • Hospital San Pau de Barcelona
  • Hospital Clinic of Barcelona
  • Hospital Germans Tríes i Pujol de Badalona
  • Hospital La Princesa de Madrid
  • Hospital Gregorio Marañon de Madrid
  • Hospital Ramón y Cajal de Madrid
  • Hospital Puerta de Hierro de Majalahonda
  • Hospital Universitario Fundación Alcorcón
  • Hospital Virgen del Rocío de Sevilla
  • Hospital Son Espases de Mallorca
  • Hospital Dr. Negrin de la Palmas
  • Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife
  • Hospital de Leon
  • Hospital POVISA de Vigo
  • Hospital Álvaro Cunqueiro de Vigo
  • Hospital de Albacete
  • Hospital Principe de Asturias de Madrid
  • Hospital Miguel Servet de Zaragoza
  • Hospital General de Ciudad Real
  • Hospital Río Hortega de Valladolid
Investigators  ICMJE
Study Director: Javier Belda, Md, PhD Department of Anesthesia and Critical Care; Hospital Clinico Universitario
PRS Account Fundación para la Investigación del Hospital Clínico de Valencia
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP