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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ARDS (Acute Respiratory Distress Syndrome)

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Markus Haar, MD; Phone Number: +4915228842916; Email: m.haar@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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	Survey period (December 2024 - March 2025).

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; ECMO; Mechanical Ventilation; Prone position; Tidal volume; ECCO2R; vvECMO; vv-ECMO
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: UKE-KIM-MH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No