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

Ventilator-Induced Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030078
• Other study ID #: 30155-2/2019/EKU
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2019
• Source: Péterfy Sándor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years and older

Eligibility

Inclusion Criteria:

• All anaesthesiologists accepting to participate the survey

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Alveolar Recruitment Manoeuvres
• Lung Injury
• Positive End-Expiratory Pressure
• Ventilator-Induced Lung Injury

Intervention

Other:
• Survey
Questionnaire-based survey

Locations

Country	Name	City	State
Hungary	Péterfy Sándor Hospital	Budapest	Pest

Sponsors (1)

Lead Sponsor	Collaborator
Péterfy Sándor Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Protocols on perioperative lung protective ventilatory management	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
Primary	Individual PEEP	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
Primary	Alveolar recruitment manoeuvres	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	Practices and preferences of PEEP titration procedures	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
Secondary	Practices and preferences of alveolar recruitment manoeuvres	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
Secondary	Adverse effects of alveolar recruitment manoeuvres	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
Secondary	Contraindications of alveolar recruitment manoeuvres	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

External Links

•   Survey Questionaire