Clinical trial NCT02158923: Individualized Perioperative Open Lung Ventilatory Strategy
Official title: Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderated-high Risk of Postoperative Pulmonary Complication
Abdominal Surgery Expected More Than Two Hours
Keywords: ventilation
lung
lung complications
postoperative complications
perioperative lung protective ventilation
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: Hospital de Manises
name: Hospital General Valencia
name: Hospital Universitario La Fe
name: Germans Trias i Pujol Hospital
name: Hospital de Sant Pau
name: Hospital del Mar
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Hospital General Universitario Gregorio Marañon
name: Hospital General Universitario de Alicante
name: Hospital Juan Canalejo
name: Hospital General Regional de León
name: Hospital Universitario Virgen de la Arrixaca
name: Hospital Miguel Servet
name: Hospital Clínico Universitario de Valladolid
name: Hospital Universitario Fundación Alcorcón
name: Hospital General de Ciudad Real
name: Hospital Universitario de Valme
name: Hospital de Basurto
name: Hospital Dr. Negrín
name: Hospital de Galdakano
name: Complejo Hospitalario de Especialidades Juan Ramón Jimenez
name: Puerta de Hierro University Hospital
First posted: 2014-06-09
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of lung and systemic postoperative complications
timeFrame: Up to 7 postoperative days
Secondary outcomes:
measure: Reduction of lung and systemic postoperative complications
timeFrame: Up to 30 postoperative days
Other outcomes:
measure: Mortality evaluation
timeFrame: 180 and 365 days postoperative
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Mar de Plata
country: Argentina
facility: Hospital Privado de la Comunidad
state: Buenos Aires
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Valencia
country: Spain
facility: Department of Anesthesia and Critical Care; Hospital Clinico Universitario
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppland
Study officials:
affiliation: Hospital Clínico Universitario Valencia
name: Carlos Ferrando, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito 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.
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.
citation: Garutti I, Errando CL, Mazzinari G, Bellon JM, Diaz-Cambronero O, Ferrando C; iPROVE network. Spontaneous recovery of neuromuscular blockade is an independent risk factor for postoperative pulmonary complications after abdominal surgery: A secondary analysis. Eur J Anaesthesiol. 2020 Mar;37(3):203-211. doi: 10.1097/EJA.0000000000001128.
citation: Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.
citation: Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1.