Scopus
YÖKSİS Eşleşti
Effects of intraoperative higher versus lower positive end-expiratory pressure during one-lung ventilation for thoracic surgery on postoperative pulmonary complications (PROTHOR): a multicentre, international, randomised, controlled, phase 3 trial
Lancet Respiratory Medicine · Ocak 2025
YÖKSİS Kayıtları
Effects of intraoperative higher versus lower positive end-expiratory pressure during one-lung ventilation for thoracic surgery on postoperative pulmonary complications (PROTHOR): a multicentre, international, randomised, controlled, phase 3 trial
The Lancet Respiratory Medicine · 2025 SCI-Expanded
PROFESÖR OĞUZHAN ARUN →
Makale Bilgileri
DergiLancet Respiratory Medicine
Yayın TarihiOcak 2025
Scopus ID2-s2.0-105022127725
Özet
Background: The effect of higher positive end-expiratory pressure (PEEP) and recruitment manoeuvres aimed at lung expansion as compared with lower PEEP without recruitment manoeuvres aimed at permissive atelectasis on postoperative pulmonary complications (PPCs) in patients undergoing one-lung ventilation (OLV) during thoracic surgery is unclear. We aimed to determine the contribution of an intraoperative lung expansion strategy to preventing PPCs. Methods: In this multicentre, randomised, controlled, international phase 3 trial (PROTHOR) conducted at 74 sites in 28 countries, we enrolled adult patients (aged ≥18 years) with a BMI of less than 35 kg/m<sup>2</sup> who were scheduled for open thoracic or video-assisted thoracoscopic surgery under general anaesthesia requiring one-lung ventilation with a double-lumen tube, with a planned operative time of more than 60 min, and an expected duration of one-lung ventilation longer than that of two-lung ventilation. Patients were randomly assigned (1:1), using permuted blocks of random size (4, 6, and 8) and stratified by study site, to receive one-lung ventilation with either a higher PEEP of 10 cm H<inf>2</inf>O and periodic lung recruitment manoeuvres (high PEEP group) or a lower PEEP of 5 cm H<inf>2</inf>O without routine recruitment manoeuvres (low PEEP group). All patients received protective tidal volumes of 5 mL/kg predicted body weight during one-lung ventilation and 7 mL/kg predicted body weight during two-lung ventilation. Postoperative assessors were masked to treatment allocation. The primary outcome was a composite of PPCs during the first 5 postoperative days, including aspiration pneumonia, moderate or severe respiratory failure, acute respiratory distress syndrome (ARDS), pulmonary infection, atelectasis, cardiopulmonary oedema, pleural effusion, non-operative pneumothorax, pulmonary infiltrates, prolonged air leak, purulent pleuritis, pulmonary embolism, and pulmonary haemorrhage. A modified intention-to-treat analysis was performed, with patients analysed according to their assigned treatment group, except in cases of withdrawal of informed consent, cancellation of surgery, and or loss to follow-up. This trial is registered with ClinicalTrials.gov (NCT02963025) and is completed. Findings: Between Jan 3, 2017, and Feb 12, 2024, 2200 patients were randomly allocated: 1099 to the high PEEP group and 1101 to the low PEEP group. 43 patients in the high PEEP group and 33 in the low PEEP group were excluded from the modified intention-to-treat analysis after randomisation. The primary outcome occurred in 555 (53·6%) of 1036 patients in the high PEEP group and 592 (56·4%) of 1049 patients in the low PEEP group (absolute risk difference –2·68 percentage points [95% CI –6·36 to 1·01]; p=0·155). Intraoperative complications occurred in 484 (49·8%) of 972 patients in the high PEEP group and in 305 (31·3%) of 974 patients in the low PEEP group (absolute risk difference 18·09 percentage points [95% CI 14·41–21·77]), among which hypotension (360 [37·3%] of 966 patients in the high PEEP group vs 140 [14·3%] of 978 in the low PEEP group) and new arrhythmias (89 [9·9%] of 899 vs 37 [3·9%] of 956) were more frequent in the high PEEP group, while hypoxaemia rescue manoeuvres were more frequent in the low PEEP group (29 [3·3%] of 888 vs 86 [8·8%] of 982). The proportions of patients with extrapulmonary postoperative complications (110 [10·6%] of 1036 vs 107 [10·2%] of 1049 patients), and the numbers of adverse events (209 vs 204 events), did not differ between groups. Interpretation: In patients with a BMI of less than 35 kg/m<sup>2</sup> undergoing thoracic surgery, one-lung ventilation using higher PEEP with recruitment manoeuvres, compared with lower PEEP without recruitment manoeuvres, did not reduce PPCs. The choice for intraoperative lung expansion or permissive atelectasis should take the individual gas-exchange and haemodynamic conditions into account, which might vary during the intraoperative period. Funding: Clinical Trials Network of the European Society of Anaesthesiology and Intensive Care; Department of Anaesthesiology and Intensive Care, University Hospital Carl Gustav Carus, Technische Universität Dresden (Dresden, Germany); Conselho Nacional de Desenvolvimento Científico e Tecnológico (Brasília, Brazil); and the Association of Anaesthetists of GB and Ireland.
Yazarlar (100)
1
Jeroen Abbenhuis
2
Ahmed Abdulmomen
3
Asead Abdyli
4
Mohamed M. Abu Elyazed
5
Pilar Aguirre Puig
6
Ilknur Hatice Akbudak
7
Can Aksu
8
Ali Alagöz
9
Malik Alhamdi
10
Shams Almadhati
11
Nasser K. Altorki
12
Sonsoles Aragón Alvarez
13
Oguzhan Arun
ORCID: 0000-0001-6101-1481
14
Mustafa Azizoglu
15
Wolfgang Baar
16
Detlef Balde
17
Boglárka Balla
18
Merve Balli Seker
19
Musaab Basheer
20
Wolfgang O. Bauer
21
Johan Bence
22
Martin H. Bernardi
23
Luca M. Bigatello
24
Elena Bignami
25
Thomas Bluth
26
Iwona Bonney
27
Belaid Bouhemad
28
Nikola Bradic
29
Luigi Brescianini
30
Jan Bruthans
31
Carolien S.E. Bulte
32
Genoveva Cadar
33
Gul Cakmak
34
Placido Calì
35
Leonarda Pia Cantatore
36
Xiaoqing Chai
37
Yi Ting Chang
38
Jiaqi Chen
39
Maria Christofaki
40
Gilda Cinnella
41
Luciana Coelho Sanches
42
Ana Constantin
43
Victor Contreras
44
Laura Corsi
45
Eduardo da Silva
46
Jérôme Defosse
47
Raffaele Deluca
48
John Diaper
49
Loes Didden
50
Evanthia Dimitriou
51
Paulo do Nascimento Junior
52
Rudin Domi
53
Laurin Dorfinger
54
Luiz Fernando dos Reis Falcão
55
Christian Douradinho
56
Mojca Drnovšek Globokar
57
Ferdane Melike Duran
58
Abdelazeem Eldawlatly
59
Hala M. El-Gendy
60
Maram I. Elmazny
61
Salah Eldin I. Elsherif
62
Moataz Maher Emara
63
Sharon Thali Enriquez de los Santos
64
Sarah Farnell-Ward
65
Renan Ferrufino
66
Marcelo Gama de Abreu
67
Lingling Gao
68
Dogu Geyik
69
Deja Gnezda
70
Steffie Goeden
71
Kristina Gorjup
72
Manuel Granell Gil
73
Ricardo Eli Guido Guerra
74
Maísa Guimarães de Castro Pereira
75
Pierre Grégoire Guinot
76
Aysegul Guven
77
Helmut Hager
78
Ling Han
79
Zehra Hatipoglu
80
Megumi Hayashi
81
Johannes Hell
82
Jan Hofland
83
Markus W. Hollmann
84
Jicheng Hu
85
Kamil Hudacek
86
Gentian Huti
87
Monika Ilic
88
Radmilo Jankovic
ORCID: 0000-0003-0742-8686
89
Anita Jegarl
90
María José Jiménez Andújar
91
Danfeng Jin
92
Tobias Kammerer
93
Vjekoslav Karadža
94
Izumi Kawagoe
95
Seher Irem Kiran Paudel
96
Thomas Kiss
97
Thea Koch
98
Nevenka Kolaric
99
Nick J. Koning
100
Kostas Kostopanagiotou
Metrikler
1
Atıf
100
Yazar