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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Hyperoxia Postoperative Complication Surgical Site Infection Drug: High FiO2 Drug: Conventional FiO2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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

Drug: High FiO2
High FiO2 with a perioperative open lung strategy

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

Drug: Conventional FiO2
Conventional FiO2 with a perioperative open lung strategy




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: seven postoperative days ]

Secondary Outcome Measures :
  1. Systemic complications [ Time Frame: seven postoperative days ]
  2. Pulmonary complications [ Time Frame: seven postoperative days ]
  3. Systemic and pulmonary complications [ Time Frame: thirty postoperative days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776046


Contacts
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Contact: Carlos Ferrando, MD, PhD 609892732 cafeoranestesia@gmail.com

Locations
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Spain
Department of Anesthesia and Critical Care; Hospital Clinico Universitario Recruiting
Valencia, Spain, 46010
Contact: Carlos ferrando, MD, PhD    609892732    cafeoranestesia@gmail.com   
Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
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
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Study Director: Javier Belda, Md, PhD Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carlos Ferrando, MD,PhD, Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT02776046    
Other Study ID Numbers: iPROVE-O2
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia:
Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
Additional relevant MeSH terms:
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Surgical Wound Infection
Postoperative Complications
Hyperoxia
Infections
Pathologic Processes
Wound Infection
Signs and Symptoms, Respiratory