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Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.

Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial.

Author information

1
Department of Anesthesiology & Critical Care, Hospital Clínico Universitario, Valencia, Spain; CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: cafeoranestesia@gmail.com.
2
Department of Anesthesiology & Critical Care, Hospital Clínico Universitario, Valencia, Spain.
3
Department of Anesthesiology & Critical Care, Hospital Universitario Sant Pau, Barcelona, Spain.
4
CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain; Hedenstierna Laboratory, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
5
Department of Anesthesiology & Critical Care, Hospital Universitario Germans Tries i Pujol, Badalona, Spain.
6
Navarrabiomed-Fundación Miguel Servet. Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Pamplona, Spain.
7
INCLIVA Clinical Research Institute, Hospital Clinico Universitario de Valencia, Valencia, Spain.
8
Centro Superior de Investigación en Salud Publica (CSISP-FISABIO), REDISSEC, Valencia, Spain.
9
IISLAFE Clinical Research Institute, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
10
Department of Anesthesiology & Critical Care, Hospital Universitario Río Hortega, Valladolid, Spain.
11
Department of Anesthesiology & Critical Care, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
12
Department of Anesthesiology & Critical Care, Hospital Universitario Ramón y Cajal, Madrid, Spain.
13
Department of Anesthesiology & Critical Care, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
14
Department of Anesthesiology & Critical Care, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
15
Department of Anesthesiology & Critical Care, Hospital Clínic i Provincial Universitario, Barcelona, Spain.
16
Department of Anesthesiology & Critical Care, Hospital Fundación de Alcorcón, Alcorcón, Spain.
17
Department of Anesthesiology, Hospital de la Marina Baixa de la Vila Joiosa, Alicante, Spain.
18
Department of Anesthesiology & Critical Care, Hospital General Universitario, Valencia, Spain.
19
Department of Anesthesiology, Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain.
20
Department of Anesthesiology & Critical Care, Hospital Universitario Miguel Servet, Zaragoza, Spain.
21
Department of Anesthesiology & Critical Care, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
22
Department of Anesthesiology, Hospital Universitario de León, León, Spain.
23
Department of Anesthesiology & Critical Care, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
24
Department of Anesthesiology, Hospital de Manises, Valencia, Spain.
25
Department of Anesthesiology & Critical Care, Hospital Principe de Asturias, Madrid, Spain.
26
Department of Anesthesiology & Critical Care, Hospital Son Espases, Palma de Mallorca, Spain.
27
Department of Anesthesiology, Hospital NS de Candelaria, Santa Cruz de Tenerife, Spain.
28
Department of Anesthesiology, Hospital Privado de Comunidad Mar de Plata, Mar de Plata, Argentina.
29
CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain; Multidisciplinary Organ Dysfunction Evaluation Research Network, Hospital Universitario Doctor Negrin, Las Palmas, Spain.
30
Department of Anesthesiology & Critical Care, Hospital Clínico Universitario, Valencia, Spain; Department of Surgery, Universidad de Valencia, Valencia, Spain.

Abstract

BACKGROUND:

The effects of individualised perioperative lung-protective ventilation (based on the open-lung approach [OLA]) on postoperative complications is unknown. We aimed to investigate the effects of intraoperative and postoperative ventilatory management in patients scheduled for abdominal surgery, compared with standard protective ventilation.

METHODS:

We did this prospective, multicentre, randomised controlled trial in 21 teaching hospitals in Spain. We enrolled patients who were aged 18 years or older, were scheduled to have abdominal surgery with an expected time of longer than 2 h, had intermediate-to-high-risk of developing postoperative pulmonary complications, and who had a body-mass index less than 35 kg/m2. Patients were randomly assigned (1:1:1:1) online to receive one of four lung-protective ventilation strategies using low tidal volume plus positive end-expiratory pressure (PEEP): open-lung approach (OLA)-iCPAP (individualised intraoperative ventilation [individualised PEEP after a lung recruitment manoeuvre] plus individualised postoperative continuous positive airway pressure [CPAP]), OLA-CPAP (intraoperative individualised ventilation plus postoperative CPAP), STD-CPAP (standard intraoperative ventilation plus postoperative CPAP), or STD-O2 (standard intraoperative ventilation plus standard postoperative oxygen therapy). Patients were masked to treatment allocation. Investigators were not masked in the operating and postoperative rooms; after 24 h, data were given to a second investigator who was masked to allocations. The primary outcome was a composite of pulmonary and systemic complications during the first 7 postoperative days. We did the primary analysis using the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02158923.

FINDINGS:

Between Jan 2, 2015, and May 18, 2016, we enrolled 1012 eligible patients. Data were available for 967 patients, whom we included in the final analysis. Risk of pulmonary and systemic complications did not differ for patients in OLA-iCPAP (110 [46%] of 241, relative risk 0·89 [95% CI 0·74-1·07; p=0·25]), OLA-CPAP (111 [47%] of 238, 0·91 [0·76-1·09; p=0·35]), or STD-CPAP groups (118 [48%] of 244, 0·95 [0·80-1·14; p=0·65]) when compared with patients in the STD-O2 group (125 [51%] of 244). Intraoperatively, PEEP was increased in 69 (14%) of patients in the standard perioperative ventilation groups because of hypoxaemia, and no patients from either of the OLA groups required rescue manoeuvres.

INTERPRETATION:

In patients who have major abdominal surgery, the different perioperative open lung approaches tested in this study did not reduce the risk of postoperative complications when compared with standard lung-protective mechanical ventilation.

FUNDING:

Instituto de Salud Carlos III of the Spanish Ministry of Economy and Competitiveness, and Grants Programme of the European Society of Anaesthesiology.

PMID:
29371130
DOI:
10.1016/S2213-2600(18)30024-9
[Indexed for MEDLINE]

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