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

Surgical Site Infection Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02776046
• Other study ID #: iPROVE-O2
• 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
• 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.

Related Conditions & MeSH terms

• Hyperoxia
• Postoperative Complication
• Postoperative Complications
• Surgical Site Infection
• Surgical Wound Infection

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