Clinical trial NCT02963025: Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery
Official title: PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: One-Lung Ventilation
Keywords: Mechanical ventilation
positive end-expiratory pressure
recruitment maneuver
one-lung ventilation
thoracic surgery
postoperative pulmonary complication
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Istanbul University
name: European Society of Anaesthesiology and Intensive Care
First posted: 2016-11-15
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP).

Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV.

Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
* BMI \< 35 kg/m2
* age ≥ 18 years
* expected duration of surgery \> 60 min
* planned lung separation with double lumen tube (DLT, not for study purpose only)
* most of ventilation time during surgery expected to be in OLV

Exclusion Criteria:

* COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax
* uncontrolled asthma
* Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4
* previous lung surgery
* documented pulmonary arterial hypertension \>25mmHg MPAP at rest or \> 40 mmHg syst. (estimated by ultrasound)
* documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others)
* planned mechanical ventilation after surgery
* bilateral procedures
* lung separation with other method than DLT (e.g. difficult airway, tracheostomy)
* surgery in prone position
* persistent hemodynamic instability, intractable shock
* intracranial injury or tumor
* enrollment in other interventional study or refusal of informed consent
* pregnancy (excluded by anamnesis and/or laboratory analysis)
* esophagectomy, pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation
* presence before induction of anaesthesia of one of the adverse events, listed as postoperative pulmonary complications (aspiration, moderate respiratory failure, infiltrates, pulmonary infection, atelectasis, cardiopulmonary edema, pleural effusion, pneumothorax, pulmonary embolism, purulent pleuritis, lung hemorrhage)
* documented preoperative hypercapnia \> 45mmHg (6kPa)

Primary outcomes:
measure: The proportion of patients developing one or more postoperative pulmonary complications
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYC Cornell Medical College
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic, USA
state: Ohio
city: Tirana
country: Albania
facility: American Hospital Tirana
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Barretos
country: Brazil
facility: Hospital de Amor, Barretos
city: São Paulo
country: Brazil
facility: Clinics Hospital from the Botucatu Medical School, University of Sao Paulo State
city: São Paulo
country: Brazil
facility: Sao Paulo Hospital
city: Santiago de Chile
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical University, China
city: Hefei
country: China
facility: Anhui Provincial Hospital, First Aff. Hospital, University of Science and Technology of China
city: Shanghai
country: China
facility: Fudan University, Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Sichuan
country: China
facility: West China Hospital Sichuan
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Zagreb
country: Croatia
facility: University Hospital Zagreb
city: Egkomi
country: Cyprus
facility: Evangelistria Medical Center, Cyprus
city: Prag
country: Czechia
facility: General University Hospital
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals, Egypt
city: Tanta
country: Egypt
facility: Tanta University Hospital
city: Dijon
country: France
facility: University Hospital of Dijon - François Mitterrand
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig
city: Dresden
country: Germany
facility: Department of Anesthesiology and Intensive Care, Dresden University of Technology
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Göttingen
country: Germany
facility: University Hospital Goettingen, Germany
city: Magdeburg
country: Germany
facility: University Hospital Magdeburg
city: München
country: Germany
facility: LMU Muenchen
city: Athens
country: Greece
facility: Attikon University Hospital
city: Athens
country: Greece
facility: Sotiria Chest Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Patras
country: Greece
facility: Patras University Hospital
city: Debrecen
country: Hungary
facility: University of Debrecen, Department of anesthesiology and Intensive Care
city: Dihok
country: Iraq
facility: Azadi Heart Center, Iraq
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna
city: Foggia
country: Italy
facility: OORR Foggia, University of Foggia
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: AOU G.Martino
city: Naples
country: Italy
facility: University Hospital Vanvitelli
city: Parma
country: Italy
facility: University Hospital of Parma
city: Rome
country: Italy
facility: University School of Medicine Campus Bio-Medico of Rome
city: Udine
country: Italy
facility: University-Hospital of Udine
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Riga
country: Latvia
facility: Riga East University Hospital, Riga, Latvia
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Amsterdam
country: Netherlands
facility: VU medical center Amsterdam
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre Nijmegen
city: Bucharest
country: Romania
facility: Institutul de Pneumoftiziologie Bucharest
city: Riyadh
country: Saudi Arabia
facility: Department of Anesthesia, College of Medicine, King Saud University Medical City, Saudi-Arabia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrad
country: Serbia
facility: University Clinical centre of Serbia, Serbia
city: Niš
country: Serbia
facility: Clinical Center Nis, Clinic for anesthesia and intensive therapy
city: Novi Sad
country: Serbia
facility: University of Novi Sad, Serbia
city: Lubiana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Barcelona
country: Spain
facility: Hospital Clínic. Universitat de Barcelona
city: Las Palmas De Gran Canaria
country: Spain
facility: Insular Hospital, Gran Canaria, Spain
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario de La Ribera
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Ankara
country: Turkey
facility: Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Bakırköy
country: Turkey
facility: University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Turkey
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University
city: Istanbul
country: Turkey
facility: Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Marmara University Medical Faculty
city: Konya
country: Turkey
facility: University of Health Science, Konya City Hospital, Turkey
city: Manisa
country: Turkey
facility: Celal Bayar University Medical Faculty, Dept of Anesthesiology
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Pamukkale
country: Turkey
facility: Pamukkale University Dinizli
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: London
country: United Kingdom
facility: St George's Hospital London
city: Sheffield
country: United Kingdom
facility: NIHS Sheffield Clinical Research Facility
Study officials:
affiliation: Istanbul University Hospital
name: Mert Sentürk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiss T, Wittenstein J, Becker C, Birr K, Cinnella G, Cohen E, El Tahan MR, Falcao LF, Gregoretti C, Granell M, Hachenberg T, Hollmann MW, Jankovic R, Karzai W, Krassler J, Loop T, Licker MJ, Marczin N, Mills GH, Murrell MT, Neskovic V, Nisnevitch-Savarese Z, Pelosi P, Rossaint R, Schultz MJ, Serpa Neto A, Severgnini P, Szegedi L, Vegh T, Voyagis G, Zhong J, Gama de Abreu M, Senturk M; PROTHOR investigators; Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA). Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):213. doi: 10.1186/s13063-019-3208-8.