- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07282899
Intraoperative Lung Protective Ventilation in Czech Republic (IOLPVCZ)
Overview of Intraoperative Lung Protective Ventilation in Czech Republic
Study Overview
Status
Conditions
Detailed Description
This study is designed as an observational cross-sectional survey focusing on attitudes, knowledge, and practical application of intraoperative lung-protective ventilation among anesthesiology professionals in the Czech Republic. The primary aim is to describe the prevalence of LPV-related practices during general anesthesia in adult surgical patients. Key elements of LPV include the use of lower tidal volumes adjusted to predicted body weight, titrated PEEP, avoidance of unnecessary high oxygen fractions, and a judicious approach to lung recruitment maneuvers. The study evaluates whether these components are routinely utilized and if so, under what clinical circumstances.
Secondary aims of the study include identifying barriers that may prevent anesthesiologists from applying LPV techniques, such as concerns about hemodynamic instability, limited training, lack of standardized protocols, insufficient monitoring capabilities, or doubts regarding clinical benefit. The survey also investigates how clinicians perceive the safety of recruitment maneuvers and whether they encounter adverse effects such as hypotension, desaturation, or barotrauma. The survey explores whether respondents view LPV as universally beneficial or applicable only to specific patient groups such as obese or critically ill individuals. The study further investigates whether national or departmental protocols and guidelines for ventilation exist at respondents' workplaces, whether ventilator settings are standardized, and whether institutional education or quality improvement initiatives support evidence-based ventilation.
The target population consists of anesthesiologists and anesthesiology trainees actively involved in perioperative care in hospitals across the Czech Republic. Participation is voluntary and anonymous, with no patient-level data collected. Demographic information such as level of training, years of experience, type of institution, and exposure to specialized perioperative or intensive care practice is included to allow subgroup comparisons. Data collection is conducted online via a secure electronic questionnaire with an estimated completion time of approximately five to eight minutes. The distribution strategy includes professional organizations, departmental mailing lists, and professional association communication channels to maximize nationwide representation.
The study utilizes a structured questionnaire composed of multiple-choice and ordinal-scale items that address five thematic categories: general anesthetic ventilation practices including tidal volume and FiO₂ selection; PEEP use and adherence to recommendations; indications and frequency of recruitment maneuvers; perceived safety and complications associated with LPV; and institutional culture, including guideline availability and ventilator technology. Respondents are asked to report how they usually manage typical elective surgical cases rather than unusual or high-risk scenarios, allowing insight into real-world standard practices. The results will quantify how closely routine clinical practice aligns with currently available scientific evidence and international perioperative ventilation recommendations.
The primary outcome is the proportion of respondents reporting ventilation settings that meet predefined LPV criteria in their routine practice. Secondary outcomes include differences in adherence between trainee and consultant anesthesiologists, between academic and non-academic hospitals, between centers with and without formal local protocols, and between clinicians with differing exposure to intensive care medicine. The data will be analyzed descriptively and comparatively to identify significant trends or variability within the national practice environment. Findings from this survey may provide a basis for future interventional or educational studies and facilitate development of nationwide recommendations.
The study is conducted in accordance with ethical research principles, including the Declaration of Helsinki and relevant European data protection regulations. Ethical approval is being obtained prior to survey initiation. Participation is fully voluntary, and no identifying personal data are collected; responses are recorded and analyzed only in aggregated form. No clinical intervention is performed, and therefore no additional risks to patients or participants are expected. The expected benefits of this research include improved understanding of current perioperative respiratory practices and identification of potential gaps where updated knowledge translation or institutional support may be necessary.
The overall purpose of this project is to contribute to improving perioperative patient outcomes by strengthening evidence-based ventilation strategies during general anesthesia. By highlighting current practice and potential challenges in implementation, the results can support targeted educational efforts, standardized national recommendations, and greater awareness of intraoperative pulmonary protection among Czech anesthesia providers. The data will also help position Czech clinical practice within the broader European context and may encourage future collaborative research initiatives focused on postoperative pulmonary complication reduction and enhanced quality of anesthesia care.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- anaesthesiologist practiting in Czech republic
Exclusion Criteria:
- not lincensed anaesthesiologist
- anaesthesiologist outside Czech republic
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to IOLPV
Time Frame: 20 days
|
Number of respondents that respond that meet IOLPV guidelines
|
20 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- IOLPVCZ
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 Intraoperative Lung Protective Ventilation
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RenJi HospitalCompletedLung-protective VentilationChina
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Rawalpindi Medical CollegeRecruitingMechanical Ventilation | Driving Pressure | Lung Protective VentilationPakistan
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Jose Ivan Rodriguez de Molina SerranoCompletedMechanical Ventilation Complication | Mechanical Power | Driving Pressure | Lung Protective VentilationMexico
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Seoul National University Bundang HospitalUnknownArterial Oxygenation During Protective One Lung VentilationKorea, Republic of
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Kocaeli UniversityRecruitingPeep Titration in Lung Protective VentilationTurkey
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Brno University HospitalRecruitingProtective VentilationCzechia
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University Hospital, Clermont-FerrandCompletedProtective Lung Ventilation Using: | Low Tidal Volume (6-8 mL/kg Predicted Body Weight) | PEEP of 6-8 cmH2O | Intraoperative RMsFrance
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Ankara City Hospital BilkentNot yet recruitingDriving Pressure | Lung Protective Ventilation | Holmium Laser Enucleation of the ProstateTurkey (Türkiye)
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Perseus MissirlisUniversity of British ColumbiaCompletedCOVID | COVID - 19 | Non-cardiac Surgery | Intraoperative Ventilation | Lung Protective VentilationCanada
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Hallym University Kangnam Sacred Heart HospitalCompletedPatients Receiving Protective Lung Ventilation | Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17South Korea