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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02963025
Other study ID # EK 392092016
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date May 2024

Study information

Verified date March 2024
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2200
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
PEEP level

Use of recruitment maneuvers


Locations

Country Name City State
Albania American Hospital Tirana Tirana
Austria Medical University of Vienna Vienna
Brazil Hospital de Amor, Barretos Barretos
Brazil Clinics Hospital from the Botucatu Medical School, University of Sao Paulo State São Paulo
Brazil Sao Paulo Hospital São Paulo
Chile Pontificia Universidad Catolica de Chile Santiago de Chile
China First Affiliated Hospital of Guangzhou Medical University, China Guangzhou
China Anhui Provincial Hospital, First Aff. Hospital, University of Science and Technology of China Hefei
China Fudan University, Shanghai Cancer Center Shanghai
China Zhongshan Hospital Fudan University Shanghai
China West China Hospital Sichuan Sichuan
Croatia University Hospital Dubrava Zagreb
Croatia University Hospital Zagreb Zagreb
Cyprus Evangelistria Medical Center, Cyprus Egkomi
Czechia General University Hospital Prag
Egypt Mansoura University Hospitals, Egypt Mansoura
Egypt Tanta University Hospital Tanta
France University Hospital of Dijon - François Mitterrand Dijon
Germany University Hospital Aachen Aachen
Germany Fachkrankenhaus Coswig Coswig
Germany Department of Anesthesiology and Intensive Care, Dresden University of Technology Dresden
Germany University Hospital Freiburg Freiburg
Germany University Hospital Goettingen, Germany Göttingen
Germany University Hospital Magdeburg Magdeburg
Germany LMU Muenchen München
Greece Attikon University Hospital Athens
Greece Sotiria Chest Hospital Athens
Greece University Hospital of Heraklion Heraklion
Greece Patras University Hospital Patras
Hungary University of Debrecen, Department of anesthesiology and Intensive Care Debrecen
Iraq Azadi Heart Center, Iraq Dihok
Italy Arcispedale Sant'Anna Ferrara
Italy OORR Foggia, University of Foggia Foggia
Italy Ospedale Policlinico San Martino Genova
Italy AOU G.Martino Messina
Italy University Hospital Vanvitelli Naples
Italy University Hospital of Parma Parma
Italy University School of Medicine Campus Bio-Medico of Rome Rome
Italy University-Hospital of Udine Udine
Japan Juntendo University Hospital Tokyo
Latvia Riga East University Hospital, Riga, Latvia Riga
Mexico Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico Tlalpan
Netherlands Academic Medical Center Amsterdam Amsterdam
Netherlands VU medical center Amsterdam Amsterdam
Netherlands Rijnstate Hospital Arnhem
Netherlands Radboud University Medical Centre Nijmegen Nijmegen
Romania Institutul de Pneumoftiziologie Bucharest Bucharest
Saudi Arabia Department of Anesthesia, College of Medicine, King Saud University Medical City, Saudi-Arabia Riyadh
Serbia University Clinical centre of Serbia, Serbia Belgrad
Serbia Military Medical Academy Belgrade
Serbia Clinical Center Nis, Clinic for anesthesia and intensive therapy Niš
Serbia University of Novi Sad, Serbia Novi Sad
Slovenia University Medical Centre Ljubljana Lubiana
Spain Hospital Clínic. Universitat de Barcelona Barcelona
Spain Insular Hospital, Gran Canaria, Spain Las Palmas De Gran Canaria
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Universitario de La Ribera Valencia
Spain Hospital Álvaro Cunqueiro Vigo
Switzerland University Hospital of Geneva Geneva
Taiwan Taichung Veterans General Hospital Taichung
Turkey Ankara Ataturk Chest Diseases And Chest Surgery Training and Research Hospital Ankara
Turkey Ankara University Medical Faculty Ankara
Turkey University of Health Sciences, Bakirköy Dr. Sadi Konuk Training and Research Hospital, Turkey Bakirköy
Turkey Acibadem Mehmet Ali Aydinlar University Istanbul
Turkey Istanbul Kartal Dr. Lutfi Kirdar Education and Research Hospital Istanbul
Turkey Istanbul University Istanbul
Turkey Marmara University Medical Faculty Istanbul
Turkey University of Health Science, Konya City Hospital, Turkey Konya
Turkey Celal Bayar University Medical Faculty, Dept of Anesthesiology Manisa
Turkey Mersin University Medical Faculty Mersin
Turkey Pamukkale University Dinizli Pamukkale
United Kingdom University Hospitals Bristol NHS Foundation Trust Bristol
United Kingdom Golden Jubilee National Hospital Clydebank
United Kingdom University Hospitals of Leicester Leicester
United Kingdom St George's Hospital London London
United Kingdom NIHS Sheffield Clinical Research Facility Sheffield
United States Tufts Medical Center Boston Massachusetts
United States Cleveland Clinic, USA Cleveland Ohio
United States NYC Cornell Medical College New York New York

Sponsors (3)

Lead Sponsor Collaborator
Technische Universität Dresden European Society of Anaesthesiology and Intensive Care, Istanbul University

Countries where clinical trial is conducted

United States,  Albania,  Austria,  Brazil,  Chile,  China,  Croatia,  Cyprus,  Czechia,  Egypt,  France,  Germany,  Greece,  Hungary,  Iraq,  Italy,  Japan,  Latvia,  Mexico,  Netherlands,  Romania,  Saudi Arabia,  Serbia,  Slovenia,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (1)

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. Erratum In: Trials. 2019 May 8;20(1):259. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients developing one or more postoperative pulmonary complications 90 days
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