- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04030078
A Central and Eastern European Survey On PEEP Titration and Alveolar Recruitment Manoeuvres During Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lung protective mechanical ventilation (LPV) is associated with a lower incidence of postoperative pulmonary complications (PPC). The pathophysiology of ventilator-induced lung injury and the risk factors of PPCs have been widely identified, and a perioperative lung protective concept has been elaborated in the past decades. The three main basic elements of LPV are application of low tidal volumes (TV < 6mL/kg), use of optimal levels of PEEP and regular alveolar recruitment manoeuvres. Despite growing evidence recent studies indicated that the entire intraoperative LPV concept is still not widely implemented in current anaesthesia practice even in high-risk surgical patients. However the use low TV is common, either PEEP individualization, or regular ARM are usually ignored, moreover these elements were considered unnecessary or even harmful and their reason is questioned from time to time.
The aim of this questionnaire-based survey (using Google Forms) is to evaluate the routine use of individual PEEP and regular ARM of Central and Eastern European anaesthesiologists during general anaesthesia, and will take approximately 10 minutes to complete.
The questionnaire consists of 29 mandatory-to-answer multiple and single choice questions. The first part of the form includes questions about demographics and hospital characteristics. The second part contains questions on the use of individual PEEP titration procedures and the third part includes questions about the use of alveolar recruitment manoeuvres during general anaesthesia.
An invitation letter will be sent to the national associations of anaesthesia of Croatia, Czech Republic, Hungary, Poland, Romania, Serbia and Slovakia. Answers will be collected in Google Forms spreadsheets and will be analyzed using MedCalc Statistical Software (MedCalc Software bvba, Ostend, Belgium).
Participation in this study is entirely voluntary and anonymous. Neither sensitive personal data nor contact information will be collected during the research. There are no known risks associated with this research study; however, as with any online related activity the risk of a breach is always possible.
This research does not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors, and the investigators declare that they do not have any conflict of interest with the work.
This international survey study and questionnaire was approved by Hungarian Medical Research Council (approval nr. 30155-2/2019/EKU, date 01/07/2019).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pest
-
Budapest, Pest, Hungary, 1076
- Péterfy Sándor Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All anaesthesiologists accepting to participate the survey
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual PEEP
Time Frame: Up to 2 months, from August to September in the year 2019
|
Answers of anaesthesiologists regarding the use of individual PEEP in routine anaesthetic care during general anaesthesia by completing the survey questionnaire. Multiple and single choice answers. Data will be expressed as percentage of respondents. Territorial and institutional differences and differences between the practice of resident doctors and specialists - if there is any - will be evaluated. |
Up to 2 months, from August to September in the year 2019
|
Alveolar recruitment manoeuvres
Time Frame: Up to 2 months, from August to September in the year 2019
|
Answers of anaesthesiologists regarding the use of alveolar recruitment manoeuvres in routine anaesthetic care during general anaesthesia by completing the survey questionnaire. Multiple and single choice answers. Data will be expressed as percentage of respondents. Territorial and institutional differences and differences between the practice of resident doctors and specialists - if there is any - will be evaluated. |
Up to 2 months, from August to September in the year 2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Practices and preferences of PEEP titration procedures
Time Frame: Up to 2 months, from August to September in the year 2019
|
Commonly used PEEP titration procedures during routine anaesthetic care will be evaluated by collection of answers to the survey.
Data will be expressed as percentage of respondents.
|
Up to 2 months, from August to September in the year 2019
|
Practices and preferences of alveolar recruitment manoeuvres
Time Frame: Up to 2 months, from August to September in the year 2019
|
Commonly used methods of alveolar recruitment manoeuvres during routine anaesthetic care will be evaluated by collection of answers to the survey.
Data will be expressed as percentage of respondents.
|
Up to 2 months, from August to September in the year 2019
|
Adverse effects of alveolar recruitment manoeuvres
Time Frame: Up to 2 months, from August to September in the year 2019
|
The most commonly observed side effects of alveolar recruitment manoeuvres will be evaluated by collection of answers to the survey.
Data will be expressed as percentage of respondents.
|
Up to 2 months, from August to September in the year 2019
|
Contraindications of alveolar recruitment manoeuvres
Time Frame: Up to 2 months, from August to September in the year 2019
|
Opinion responses of survey participants about the contraindications of the use of any type of alveolar recruitment manoeuvres in their daily practice.
Data will be expressed as percentage of respondents.
|
Up to 2 months, from August to September in the year 2019
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protocols on perioperative lung protective ventilatory management
Time Frame: Up to 2 months, from August to September in the year 2019
|
Answers of respondents regarding the availability of written institutional protocols on perioperative lung protective ventilatory management by completing the survey questionnaire.
Data will be expressed as percentage of respondents.
|
Up to 2 months, from August to September in the year 2019
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zoltán Ruszkai, MD, Péterfy Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30155-2/2019/EKU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventilator-Induced Lung Injury
-
Ayse UlgeyNot yet recruitingVentilator-induced Lung InjuryTurkey
-
Lungpacer Medical Inc.CompletedVentilator Induced Lung InjuryParaguay
-
Capital Medical UniversityBeijing Tiantan HospitalCompleted
-
Lingling DingNot yet recruitingElectroacupuncture | Lung Injury, Ventilator Induced
-
Shanghai Zhongshan HospitalUnknownMechanical Ventilation | Transpulmonary Pressure | Ventilator-induced Lung InjuryChina
-
Kocaeli UniversityCompletedVentilator-Induced Lung Injury | Ventilator Adverse Event | Lung Injury, AcuteTurkey
-
Gazi UniversityCompletedVentilator Induced Lung Injury | Respiratory Distress, NewbornTurkey
-
E-DA HospitalCompletedVentilator-Induced Lung Injury | One-lung Ventilation | Lung VentilatorTaiwan
-
University of Sao PauloInCor Heart InstituteCompletedAcute Lung Injury | Cardiac Disease | Ventilator Induced Lung InjuryBrazil
-
University Hospital OstravaRecruitingARDS | Lung Injury, Ventilator InducedCzechia
Clinical Trials on Survey
-
Johns Hopkins Bloomberg School of Public HealthPontificia Universidad JaverianaCompletedNoncommunicable Diseases | Surveys and QuestionnairesColombia
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Ohio State UniversityWithdrawnMedicare Part DUnited States
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health InstituteCompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania
-
Memorial Sloan Kettering Cancer CenterCompletedInpatients With Limited English ProficiencyUnited States
-
Lawson Health Research InstituteCompletedEvaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation ParticipationMyocardial Infarction | Unstable Angina | Coronary Angioplasty | Coronary Artery Bypass SurgeryCanada
-
University GhentCompletedStroke | Upper Extremity Paresis | Survey
-
Assistance Publique - Hôpitaux de ParisUniversité de Cergy PontoiseCompleted
-
Weill Medical College of Cornell UniversityBoston Children's Hospital; Brigham and Women's Hospital; The Commonwealth FundCompletedPediatric ALLUnited States