Individualized Perioperative Open Lung Ventilatory Strategy

Abdominal Surgery Expected More Than Two Hours Clinical Trial

— iPROVE  

Official title:

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02158923
• Other study ID #: iPROVE
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2014
• Last updated: January 20, 2016
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: Carlos Ferrando, MD, PhD
• Phone: 0034963862600
• Email: info[@]anestesiaclinicovalencia.org
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether individualized ventilatory management combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and postoperative individualized ventilatory support will decrease postoperative complications, unplanned ICU readmissions, ICU and hospital length of stay and mortality compared to a standardized Lung Protective Ventilation (LPV) for all patients at risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age not less than 18

• Risk of postoperative pulmonary complication moderate-high defined by a score = 26 on the risk scale ARISCAT (based on the analysis of seven factors, where a score between 26 and 44 points defines a moderate risk, and a score> 44 points define a high risk, included in the Information Booklet Investigator).

• 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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Surgery Expected More Than Two Hours
• Moderated-high Risk of Postoperative Pulmonary Complication
• Postoperative Complications

Intervention

Procedure:
• Alveolar recruitment maneuver
To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
• Calculation of optimal PEEP
Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .
• Postoperative CPAP
Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.

Locations

Country	Name	City	State
Argentina	Hospital Privado de la Comunidad	Mar de Plata	Buenos Aires
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Gregorio Marañón	Madrid
Spain	Department of Anesthesia and Critical Care; Hospital Clinico Universitario	Valencia
Sweden	Uppsala University Hospital	Uppsala	Uppland
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (23)

Lead Sponsor

Collaborator

Fundación para la Investigación del Hospital Clínico de Valencia

Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Germans Trias i Pujol Hospital, Hospital Clínico Universitario de Valladolid, Hospital Consorcio General de Valencia, Hospital de Basurto, Hospital de Galdakano, Hospital de Manises, Hospital de Sant Pau, Hospital del Mar, Hospital Dr. Negrín, Hospital General de Ciudad Real, Hospital General Regional de León, Hospital General Universitario de Alicante, Hospital General Universitario Gregorio Marañon, Hospital Juan Canalejo, Hospital Miguel Servet, Hospital Universitario de la Princesa, Hospital Universitario de Valme, Hospital Universitario Fundación Alcorcón, Hospital Universitario La Fe, Hospital Universitario Virgen de la Arrixaca, Puerta de Hierro University Hospital

Countries where clinical trial is conducted

United States,  Argentina,  Spain,  Sweden, 

References & Publications (3)

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

PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology, Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2. — View Citation

Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Espósito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality evaluation		180 and 365 days postoperative	No
Primary	Reduction of lung and systemic postoperative complications		Up to 7 postoperative days	No
Secondary	Reduction of lung and systemic postoperative complications		Up to 30 postoperative days	No