NCT06714201

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 19, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

ARDSProne positionECMOECCO2RvvECMOvv-ECMOMechanical VentilationTidal volume

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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°).

    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

    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)

    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.

    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.

    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.

    Survey period (December 2024 - March 2025)

Secondary Outcomes (6)

  • Proportion of ICUs using volume-controlled vs pressure-controlled ventilation.

    Survey period (December 2024 - March 2025)

  • Types of PEEP titration methods and recruitment manoeuvres.

    Survey period (December 2024 - March 2025)

  • Proportion of ICUs using NMBAs for ARDS patients.

    Survey period (December 2024 - March 2025).

  • Frequency of corticosteroid and nitric oxide use.

    Survey period (December 2024 - March 2025)

  • Proportion of ICUs with ECMO/ECCO2R availability and implementation.

    Survey period (December 2024 - March 2025).

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Healthcare professionals (physicians and nurses) who are currently employed in an ICU that treats ARDS patients and are actively involved in their management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Markus Haar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Internal Medicine

Study Record Dates

First Submitted

November 19, 2024

First Posted

December 3, 2024

Study Start

December 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share