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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02776046
Other study ID # iPROVE-O2
Secondary ID
Status Recruiting
Phase N/A
First received May 15, 2016
Last updated February 23, 2018
Start date June 1, 2017
Est. completion date February 2019

Study information

Verified date February 2018
Source Fundación para la Investigación del Hospital Clínico de Valencia
Contact Carlos Ferrando, MD, PhD
Phone 609892732
Email cafeoranestesia@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 756
Est. completion date February 2019
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Spain Department of Anesthesia and Critical Care; Hospital Clinico Universitario Valencia

Sponsors (26)

Lead Sponsor Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia Hospital Álvaro Cunqueiro de Vigo, Hospital Clinic of Barcelona, Hospital de Albacete, Hospital de Elche, Hospital de Leon, Hospital de Manises, Hospital de Villajoyosa, Hospital Dr. Negrin de la Palmas, Hospital Fundación de Alcorcon, Hospital General de Ciudad Real, Hospital General de Valencia, Hospital Germans Tríes i Pujol de Badalona, Hospital Gregorio Marañon de Madrid, Hospital La Fe de Valencia, Hospital La Princesa de Madrid, Hospital Miguel Servet de Zaragoza, Hospital Nuestra Señora de la Candelaria de Santa Cruz de Tenerife, Hospital POVISA de Vigo, Hospital Principe de Asturias de Madrid, Hospital Puerta de Hierro de Majalahonda, Hospital Ramón y Cajal de Madrid, Hospital Río Hortega de Valladolid, Hospital San Pau de Barcelona, Hospital Son Espases de Mallorca, Hospital Virgen del Rocío de Sevilla

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Belda FJ, Aguilera L, García de la Asunción J, Alberti J, Vicente R, Ferrándiz L, Rodríguez R, Company R, Sessler DI, Aguilar G, Botello SG, Ortí 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. Erratum in: JAMA. 2005 Dec 21;294(23):2973. — View 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. — View Citation

Greif R, Akça 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. — View Citation

Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Høgdall 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, Heltø 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical site infection seven postoperative days
Secondary Systemic complications seven postoperative days
Secondary Pulmonary complications seven postoperative days
Secondary Systemic and pulmonary complications thirty postoperative days
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