Back to resultsIndividualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). (iPROVE-O2)
Primary Purpose
Hyperoxia, Postoperative Complication, Surgical Site Infection
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High FiO2
Conventional FiO2
Sponsored by
About this trial
This is an interventional prevention trial for Hyperoxia focused on measuring Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
Eligibility 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.
Sites / Locations
- Department of Anesthesia and Critical Care; Hospital Clinico UniversitarioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High FiO2
Conventional FiO2
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. Postoperatively 3h with 0.8 FiO2 and individualized CPAP
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
Outcomes
Primary Outcome Measures
Surgical site infection
Secondary Outcome Measures
Systemic complications
Pulmonary complications
Systemic and pulmonary complications
Full Information
NCT ID
NCT02776046
First Posted
May 15, 2016
Last Updated
February 23, 2018
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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
1. Study Identification
Unique Protocol Identification Number
NCT02776046
Brief Title
Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).
Acronym
iPROVE-O2
Official Title
Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxia, Postoperative Complication, Surgical Site Infection
Keywords
Oxygen, surgical site infection, postoperative complication, recruitment maneuvers, open lung strategy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
756 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High FiO2
Arm Type
Experimental
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.
Postoperatively 3h with 0.8 FiO2 and individualized CPAP
Arm Title
Conventional FiO2
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
High FiO2
Intervention Description
High FiO2 with a perioperative open lung strategy
Intervention Type
Drug
Intervention Name(s)
Conventional FiO2
Intervention Description
Conventional FiO2 with a perioperative open lung strategy
Primary Outcome Measure Information:
Title
Surgical site infection
Time Frame
seven postoperative days
Secondary Outcome Measure Information:
Title
Systemic complications
Time Frame
seven postoperative days
Title
Pulmonary complications
Time Frame
seven postoperative days
Title
Systemic and pulmonary complications
Time Frame
thirty postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Ferrando, MD, PhD
Phone
609892732
Email
cafeoranestesia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Belda, Md, PhD
Organizational Affiliation
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos ferrando, MD, PhD
Phone
609892732
Email
cafeoranestesia@gmail.com
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
16249417
Citation
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. Erratum In: JAMA. 2005 Dec 21;294(23):2973.
Results Reference
background
PubMed Identifier
19826023
Citation
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.
Results Reference
background
PubMed Identifier
10639541
Citation
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.
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
31767144
Citation
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.
Results Reference
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PubMed Identifier
28760799
Citation
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.
Results Reference
derived
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Individualized Perioperative Open-lung Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2).
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