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J Cardiothorac Vasc Anesth. 2019 Feb 8. pii: S1053-0770(19)30092-8. doi: 10.1053/j.jvca.2019.01.056. [Epub ahead of print]

Rationale and Study Design for an Individualized Perioperative Open Lung Ventilatory Strategy in Patients on One-Lung Ventilation (iPROVE-OLV).

Author information

1
Department of Anesthesia and Critical Care, Hospital Clínic i Provincial, Barcelona,Spain.
2
Department of Anesthesia and Critical Care, Hospital Clínic i Provincial, Barcelona,Spain; CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: cafeornaestesia@gmail.com.
3
Department of Anesthesia and Critical Care, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
4
CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain; Intensive Care Unit, Hospital de La Princesa, Madrid, Spain; Hedenstierna Laboratory, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
5
Department of Anesthesia, Hospital Privado de Mar de Plata, Mar de Plata, Argentina.
6
Department of Anesthesia and Critical Care, Hospital Universitario Gregorio Marañon, Madrid, Spain.
7
Department of Anesthesia and Critical Care, Hospital Clínico of Valencia, Valencia, Spain.
8
Institute INCLIVA, Hospital Clinico Universitario de Valencia, Valencia, Spain.
9
Navarrabiomed-Fundación Miguel Servet, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Pamplona, Spain.
10
Department of Anesthesia and Critical Care, Hospital Miguel Servet, Zaragoza, Spain.
11
Department of Anesthesia and Critical Care, Hospital La Princesa, Madrid, Spain.
12
Department of Anesthesia and Critical Care, Hospital Marqués de Valdecilla, Santander, Spain.
13
Department of Anesthesia, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain.
14
Department of Anesthesia and Critical Care t, Hospital de Salamanca, Salamanca, Spain.
15
Department of Anesthesia and Critical Care, Hospital Universitari Mutua of Terrassa, Terrassa, Spain.
16
Department of Anesthesia and Critical Care, Hospital Univeristari de Vinalopó, Elche, Spain.
17
Department of Anesthesia and Critical Care, Hospital 12 de Octubre, Madrid, Spain.
18
Department of Anesthesia and Critical Care, Hospital Álvaro Cunqueiro, Vigo, Spain.
19
Department of Anesthesia and Critical Care, Clínica Universitaria Pamplona, Spain.
20
Department of Anesthesia and Critical Care, Hospital Universitario La Fe, Valencia, Spain.
21
Department of Anesthesia and Critical Care, Hospital Vírgen del Rocio, Sevilla, Spain.
22
Department of Anesthesia and Critical Care, Hospital Povisa, Vigo, Spain.
23
Department of Anesthesia and Critical Care, Hospital Dr. Josep Trueta, Girona, Spain.
24
Department of Anesthesia and Critical Care, Fundación Jiménez Díaz, Madrid, Spain.
25
Department of Anesthesia, Complejo Universitario Materno-Insular, Las Palmas, Spain.
26
Department of Anesthesia and Critical Care, Hospital Universitario Central de Asturias, Oviedo, Spain.
27
Department of Anesthesia and Critical Care, Hospital Universitario de Canarias, Tenerife, Spain.
28
Department of Anesthesia and Critical Care, Università di Foggia, Foggia, Italy.
29
Department of Anesthesia and Critical Care, Università di Ferrara, Ferrara, Italy.
30
Anesthesia and Critical Care, Centre Hospitalier Universitaire, Clermont-Ferrand, France.
31
Department of Anesthesia, Universidad El Bosque, Bogotá, Colombia.
32
Department of Anesthesia, Hospital Clínico de la Fuerza Aérea de Chile, Las Condes, Chile.
33
Department of Anesthesia and Critical Care, Centro Hospitalar Sao Joao, Porto, Portugal.
34
Department of Anesthesia and Critical Care, Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal.
35
Anesthesia and Critical Care, Medical Park Bahçelievler Hospital, Istanbul, Turkey.
36
Department of Anesthesia and Critical Care, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
37
Critical Care Department, Hospital de especialidades Eugenio Espejo, Quito, Ecuador.
38
Department of Anesthesia, Alexandria University Hospital and Kafrelsheikh University Hospital, Alexandria, Egypt.
39
Department of Anesthesia and Critical Care, Hospital Universitario Ntra Sra de Candelaria, Santa Cruz de Tenerife, Spain.
40
CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain; Research Unit, Hospital Universitario Dr. Negrín, Las Palmas de Gran Canaria, Spain.

Abstract

OBJECTIVE:

The aim of this clinical trial is to examine whether it is possible to reduce postoperative complications using an individualized perioperative ventilatory strategy versus using a standard lung-protective ventilation strategy in patients scheduled for thoracic surgery requiring one-lung ventilation.

DESIGN:

International, multicenter, prospective, randomized controlled clinical trial.

SETTING:

A network of university hospitals.

PARTICIPANTS:

The study comprises 1,380 patients scheduled for thoracic surgery.

INTERVENTIONS:

The individualized group will receive intraoperative recruitment maneuvers followed by individualized positive end-expiratory pressure (open lung approach) during the intraoperative period plus postoperative ventilatory support with high-flow nasal cannula, whereas the control group will be managed with conventional lung-protective ventilation.

MEASUREMENTS AND MAIN RESULTS:

Individual and total number of postoperative complications, including atelectasis, pneumothorax, pleural effusion, pneumonia, acute lung injury; unplanned readmission and reintubation; length of stay and death in the critical care unit and in the hospital will be analyzed for both groups. The authors hypothesize that the intraoperative application of an open lung approach followed by an individual indication of high-flow nasal cannula in the postoperative period will reduce pulmonary complications and length of hospital stay in high-risk surgical patients.

KEYWORDS:

mechanical ventilation; one-lung ventilation; positive end-expiratory pressure; postoperative pulmonary complications; recruitment maneuvers

PMID:
30928294
DOI:
10.1053/j.jvca.2019.01.056

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