ARDS (Acute Respiratory Distress Syndrome)CUPIDONCT06714201
CUrrent Practices of Intensive Care for the Management of Acute Respiratory Distress Syndrome in EurOpe.
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
This study seeks to gain a comprehensive understanding of current ARDS management practices across European ICUs, with a particular focus on the use of LTV and PP therapy, which have been shown to improve outcomes in ARDS patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of healthcare professionals directly involved in the management of ARDS patients in European ICUs. This includes a multidisciplinary group of: * Physicians at various levels of responsibility and expertise, such as medical directors, senior physicians, attending consultants, and assistant physicians. * ICU nurses actively participating in the care and management of ARDS patients. To ensure broad and representative participation, we will collaborate with national representatives who are engaged in ARDS research. These representatives will be instrumental in leveraging their professional networks to facilitate access to local clinicians working in ICUs. By doing so, we aim to capture a diverse and comprehensive range of clinical practices and insights into the management of ARDS across Europe.
Who may be able to join
- Healthcare professionals (physicians and nurses) who are currently employed in an ICU that treats ARDS patients and are actively involved in their management.
Who cannot join
- There are no specific exclusion criteria for this study, as the aim is to gather as broad a range of perspectives and practices as possible from ICUs treating ARDS patients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study seeks to gain a comprehensive understanding of current ARDS management practices across European ICUs, with a particular focus on the use of LTV and PP therapy, which have been shown to improve outcomes in ARDS patients. The primary objectives focus on evaluating how LTV and PP are implemented across different institutions, while secondary objectives encompass a broader assessment of other ARDS treatment strategies. These include mechanical ventilation approaches, including PEEP titration, the use of NMBAs, and advanced extra-corporal therapies like ECMO and extracorporeal carbon dioxide removal (ECCO2R). Additionally, the study will explore diagnostic methods and decision-making processes that guide ARDS management in diverse clinical settings.
Read the detailed description
This is a cross-sectional survey designed to collect data on the current practices of ARDS management in ICUs across Europe. The survey will be administered electronically, allowing for the efficient collection of responses from a broad and diverse group of healthcare professionals.
- Keywords
- ARDS, Prone position, ECMO, ECCO2R, vvECMO, vv-ECMO, Mechanical Ventilation, Tidal volume
- Medical subject headings
- Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ICUs utilising prone positioning for ARDS patients.
This measure evaluates the adoption of prone positioning therapy across ICUs in Europe, capturing variations in its implementation for ARDS patients.
Measured: Survey period (December 2024 - March 2025)
PaO2/FiO2 threshold for starting prone positioning.
This measure represants a categorical variable and captures the clinical thresholds for initiating prone positioning, based on the PaO2/FiO2 ratio.
Measured: Survey period (December 2024 - March 2025)
Distribution of the extent of prone positioning used in participating ICUs.
This measure categorises the extent of prone positioning in ARDS patients based on typical positioning angles (e.g., 135°, 180°) and reports the proportion of ICUs using each category.
Unit of Measure: Percentage of ICUs per category (e.g., 135°, 180°).
Measured: Survey period (December 2024 - March 2025).
Mean duration per prone positioning cycles.
Evaluates the typical duration of individual prone positioning cycle. Unit of Measure: Hours per cycle
Measured: Survey period (December 2024 - March 2025)
Mean minimum number of prone position cycles.
Evaluates the minumum number of prone position cycles per patient, regardless of therapy response.
Unit of Measure: number of cycles (count)
Measured: Survey period (December 2024 - March 2025)
Commonly reported criteria for ending prone positioning therapy.
Assesses clinical and physiological criteria used to determine the cessation of prone positioning, such as oxygenation improvements or complications. Descriptive frequencies of criteria.
Measured: Survey period (December 2024 - March 2025)
Proportion of ICUs adhering to tidal volume restrictions
Measures the compliance of ICUs with evidence-based lung-protective ventilation strategies in ARDS patients, focusing on tidal volume settings.
Unit of Measure: Percentage.
Measured: Survey period (December 2024 - March 2025)
Mean tidal volumes used for mild, moderate, and severe ARDS.
Captures variations in tidal volume settings based on the severity of ARDS, aiming to identify trends in lung-protective strategies.
Unit of Measure: mL/kg predicted body weight.
Measured: Survey period (December 2024 - March 2025)
Secondary outcomes (6)
Proportion of ICUs using volume-controlled vs pressure-controlled ventilation.
Examines ICU preferences for mechanical ventilation modes, highlighting trends in volume-controlled and pressure-controlled ventilation strategies.
Unit of Measure: Percentage.
Measured: Survey period (December 2024 - March 2025)
Types of PEEP titration methods and recruitment manoeuvres.
Evaluates PEEP titration strategies, including the use of recruitment manoeuvres and their clinical application in ARDS management.
Unit of Measure: Percentage.
Measured: Survey period (December 2024 - March 2025)
Proportion of ICUs using NMBAs for ARDS patients.
Captures the frequency of NMBA use and its role in facilitating lung-protective ventilation in ARDS management.
Unit of Measure: Percentage.
Measured: Survey period (December 2024 - March 2025).
Frequency of corticosteroid and nitric oxide use.
Investigates the use of adjunct pharmacological therapies in ARDS management, focusing on corticosteroids and inhaled nitric oxide.
Unit of Measure: Percentage.
Measured: Survey period (December 2024 - March 2025)
Proportion of ICUs with ECMO/ECCO2R availability and implementation.
Assesses the availability of advanced extracorporeal therapies and their integration into ARDS treatment protocols.
Unit of Measure: Percentage.
Measured: Survey period (December 2024 - March 2025).
Variation in prone position extent by country.
Explores the influence of country of medical practice on the extent of prone position being performed (full prone position vs. parital prone position).
Unit of Measure: Proportions
Measured: Survey period (December 2024 - March 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Trento, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Genova, University of Hamburg-Eppendorf
- Responsible party
- Principal investigator, Markus Haar, University of Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714201
- Sponsor's protocol ID
- UKE-KIM-MH-001
- Acronym
- CUPIDO
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CUrrent Practices of Intensive Care for the Management of Acute Respiratory Distress Syndrome in EurOpe.
- ClinicalTrials.gov ID
- NCT06714201
- Acronym / sponsor ID
- CUPIDO / UKE-KIM-MH-001
- Keywords
- ARDS, Prone position, ECMO, ECCO2R, vvECMO, vv-ECMO, Mechanical Ventilation, Tidal volume
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Università degli Studi di Trento, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Genova, University of Hamburg-Eppendorf
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 3 Dec 2024 (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.
This study seeks to gain a comprehensive understanding of current ARDS management practices across European ICUs, with a particular focus on the use of LTV and PP therapy, which have been shown to improve outcomes in ARDS patients. The primary objectives focus on evaluating how LTV and PP are implemented across different institutions, while secondary objectives encompass a broader assessment of other ARDS treatment strategies. These include mechanical ventilation approaches, including PEEP titration, the use of NMBAs, and advanced extra-corporal therapies like ECMO and extracorporeal carbon dioxide removal (ECCO2R). Additionally, the study will explore diagnostic methods and decision-making processes that guide ARDS management in diverse clinical settings.
Detailed description
This is a cross-sectional survey designed to collect data on the current practices of ARDS management in ICUs across Europe. The survey will be administered electronically, allowing for the efficient collection of responses from a broad and diverse group of healthcare professionals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of healthcare professionals directly involved in the management of ARDS patients in European ICUs. This includes a multidisciplinary group of: * Physicians at various levels of responsibility and expertise, such as medical directors, senior physicians, attending consultants, and assistant physicians. * ICU nurses actively participating in the care and management of ARDS patients. To ensure broad and representative participation, we will collaborate with national representatives who are engaged in ARDS research. These representatives will be instrumental in leveraging their professional networks to facilitate access to local clinicians working in ICUs. By doing so, we aim to capture a diverse and comprehensive range of clinical practices and insights into the management of ARDS across Europe.
Key inclusion criteria (1 listed)
- Healthcare professionals (physicians and nurses) who are currently employed in an ICU that treats ARDS patients and are actively involved in their management.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study, as the aim is to gather as broad a range of perspectives and practices as possible from ICUs treating ARDS patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of ICUs utilising prone positioning for ARDS patients.
Time frame: Survey period (December 2024 - March 2025)
This measure evaluates the adoption of prone positioning therapy across ICUs in Europe, capturing variations in its implementation for ARDS patients.
PaO2/FiO2 threshold for starting prone positioning.
Time frame: Survey period (December 2024 - March 2025)
This measure represants a categorical variable and captures the clinical thresholds for initiating prone positioning, based on the PaO2/FiO2 ratio.
Distribution of the extent of prone positioning used in participating ICUs.
Time frame: Survey period (December 2024 - March 2025).
This measure categorises the extent of prone positioning in ARDS patients based on typical positioning angles (e.g., 135°, 180°) and reports the proportion of ICUs using each category. Unit of Measure: Percentage of ICUs per category (e.g., 135°, 180°).
Mean duration per prone positioning cycles.
Time frame: Survey period (December 2024 - March 2025)
Evaluates the typical duration of individual prone positioning cycle. Unit of Measure: Hours per cycle
Mean minimum number of prone position cycles.
Time frame: Survey period (December 2024 - March 2025)
Evaluates the minumum number of prone position cycles per patient, regardless of therapy response. Unit of Measure: number of cycles (count)
Commonly reported criteria for ending prone positioning therapy.
Time frame: Survey period (December 2024 - March 2025)
Assesses clinical and physiological criteria used to determine the cessation of prone positioning, such as oxygenation improvements or complications. Descriptive frequencies of criteria.
Proportion of ICUs adhering to tidal volume restrictions
Time frame: Survey period (December 2024 - March 2025)
Measures the compliance of ICUs with evidence-based lung-protective ventilation strategies in ARDS patients, focusing on tidal volume settings. Unit of Measure: Percentage.
Mean tidal volumes used for mild, moderate, and severe ARDS.
Time frame: Survey period (December 2024 - March 2025)
Captures variations in tidal volume settings based on the severity of ARDS, aiming to identify trends in lung-protective strategies. Unit of Measure: mL/kg predicted body weight.
6 secondary outcomes
Proportion of ICUs using volume-controlled vs pressure-controlled ventilation.
Time frame: Survey period (December 2024 - March 2025)
Types of PEEP titration methods and recruitment manoeuvres.
Time frame: Survey period (December 2024 - March 2025)
Proportion of ICUs using NMBAs for ARDS patients.
Time frame: Survey period (December 2024 - March 2025).
Frequency of corticosteroid and nitric oxide use.
Time frame: Survey period (December 2024 - March 2025)
Proportion of ICUs with ECMO/ECCO2R availability and implementation.
Time frame: Survey period (December 2024 - March 2025).
Variation in prone position extent by country.
Time frame: Survey period (December 2024 - March 2025).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome), run by Universitätsklinikum Hamburg-Eppendorf.
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: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Markus Haar, MD (+4915228842916, m.haar@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ICUs utilising prone positioning for ARDS patients. (time frame: Survey period (December 2024 - March 2025)). The study lists 8 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 3 Dec 2024.