Ventilator-Induced Lung InjuryNCT04030078
A Central and Eastern European Survey On PEEP Titration and Alveolar Recruitment Manoeuvres During Surgery
An observational study of Ventilator-Induced Lung Injury and Positive End-Expiratory Pressure, run by Péterfy Sándor Hospital at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilator-Induced Lung Injury, Positive End-Expiratory Pressure, Alveolar Recruitment Manoeuvres
- What is being tested?
- Survey
- How many people
- 87 participants
- Where
- 1 siteHungary
- Study dates
- 1 Aug 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- All anaesthesiologists accepting to participate the survey
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Ventilator-Induced Lung Injury, Positive End-Expiratory Pressure, Alveolar Recruitment Manoeuvres
- Being tested
- Survey
- Keywords
- PEEP, Alveolar Recruitment Manoeuvres, Survey
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Questionnaire-based survey
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 months, from August to September in the year 2019
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.
Measured: Up to 2 months, from August to September in the year 2019
Secondary outcomes (4)
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.
Measured: Up to 2 months, from August to September in the year 2019
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.
Measured: Up to 2 months, from August to September in the year 2019
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.
Measured: Up to 2 months, from August to September in the year 2019
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.
Measured: Up to 2 months, from August to September in the year 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Péterfy Sándor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zoltán Ruszkai, Péterfy Sándor Hospital
- Investigators
- Zoltán Ruszkai, MD, Principal investigator, Péterfy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030078
- Sponsor's protocol ID
- 30155-2/2019/EKU
- Status last verified
- Nov 2019
- First submitted
- 13 Jul 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Central and Eastern European Survey On PEEP Titration and Alveolar Recruitment Manoeuvres During Surgery
- ClinicalTrials.gov ID
- NCT04030078
- Acronym / sponsor ID
- 30155-2/2019/EKU
- Conditions
- Ventilator-Induced Lung Injury, Positive End-Expiratory Pressure, Alveolar Recruitment Manoeuvres
- Keywords
- PEEP, Alveolar Recruitment Manoeuvres, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Péterfy Sándor HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All anaesthesiologists accepting to participate the survey
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyQuestionnaire-based survey | Other | – |
Primary outcome
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.
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.
4 secondary outcomes
Practices and preferences of PEEP titration procedures
Time frame: 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
Adverse effects of alveolar recruitment manoeuvres
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Survey QuestionaireLink provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoltán Ruszkai, MD principal investigator
Péterfy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Induced Lung Injury and Positive End-Expiratory Pressure, run by Péterfy Sándor Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual PEEP (time frame: Up to 2 months, from August to September in the year 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.