A Central and Eastern European Survey On PEEP Titration and Alveolar Recruitment Manoeuvres During Surgery

November 1, 2019 updated by: Dr. Zoltán Ruszkai, Péterfy Sándor Hospital
The aim of this questionnaire-based survey is to evaluate the routine use of individual positive end-expiratory pressure (PEEP) and regular alveolar recruitment manoeuvres (ARM) of Central and Eastern European anaesthesiologists during general anaesthesia.

Study Overview

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

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pest
      • Budapest, Pest, Hungary, 1076
        • Péterfy Sándor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Resident doctors, specialist candidates and specialist working in the field of anaesthesia, employed in Croatia, Czech Republic, Hungary, Poland, Romania, Serbia and Slovakia

Description

Inclusion Criteria:

- All anaesthesiologists accepting to participate the survey

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zoltán Ruszkai, MD, Péterfy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (ACTUAL)

July 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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