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NCT Number: NCT06714201

CUrrent Practices of Intensive Care for the Management of Acute Respiratory Distress Syndrome in EurOpe.

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.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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°).

  4. 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

  5. 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)

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

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

    Time frame: Survey period (December 2024 - March 2025)

    Examines ICU preferences for mechanical ventilation modes, highlighting trends in volume-controlled and pressure-controlled ventilation strategies.

    Unit of Measure: Percentage.

  2. Types of PEEP titration methods and recruitment manoeuvres.

    Time frame: Survey period (December 2024 - March 2025)

    Evaluates PEEP titration strategies, including the use of recruitment manoeuvres and their clinical application in ARDS management.

    Unit of Measure: Percentage.

  3. Proportion of ICUs using NMBAs for ARDS patients.

    Time frame: Survey period (December 2024 - March 2025).

    Captures the frequency of NMBA use and its role in facilitating lung-protective ventilation in ARDS management.

    Unit of Measure: Percentage.

  4. Frequency of corticosteroid and nitric oxide use.

    Time frame: Survey period (December 2024 - March 2025)

    Investigates the use of adjunct pharmacological therapies in ARDS management, focusing on corticosteroids and inhaled nitric oxide.

    Unit of Measure: Percentage.

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

    Time frame: Survey period (December 2024 - March 2025).

    Assesses the availability of advanced extracorporeal therapies and their integration into ARDS treatment protocols.

    Unit of Measure: Percentage.

  6. Variation in prone position extent by country.

    Time frame: Survey period (December 2024 - March 2025).

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Markus Haar, MD

CONTACT

[email protected]

+4915228842916

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University of Genova
  • University of Hamburg-Eppendorf
  • Università degli Studi di Trento

Registry information

Acronym: CUPIDO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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