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Clinical Trials in Spain / NCT06857513
Starting soon Observational

Post-ICU Syndrome Over Time in Patients With Respiratory Failure

NCT06857513 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitario de Gran Canaria Doctor Negrín
Phase
Observational
Started
2025-10-01
Last updated
2025-09-08

Condition(s) studied

Post-Intensive Care SyndromeQuality of Life

Investigational drug(s) / intervention(s)

Questionnaire and Physical ExamEuroQol 5-Dimension 3-LevelEuroQol Visual Analogue Scale (EQ-VAS)

Questionnaire and Physical Exam: Patients will be interviewed about the current suffering of post-intensive care symptoms

EuroQol 5-Dimension 3-Level: to assess health-related quality of life, focusing on the assessment of five key dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression.

EuroQol Visual Analogue Scale (EQ-VAS): records the patient's self-rated health on a vertical visual analogue scale where endpoints are labelled: 0 "best imaginable health" - 100 "worst imaginable health"

Study summary

Intensive Care Units (ICU) stabilize and maintain vital functions in critically ill patients, optimizing their survival. However, patients with prolonged stays may develop Post-ICU syndrome , characterized by physical, cognitive and psychological dysfunctions. This syndrome considerably affects the quality of life of patients. The risk of post-ICU syndrome is associated with factors such as advanced age, delirium, prolonged sedation and mechanical ventilation.

The main objective of this study is to assess the temporal evolution of post-ICU syndrome in patients who required mechanical ventilation for more than 48 hours, analyzing its incidence, associated risk factors and the impact on their long-term quality of life.

This cross-sectional study evaluates the presence of post-ICU syndrome in 2025 in patients who have been admitted to the ICU during 2021 and 2024 who required invasive mechanical ventilation for more than 48 hours. Of this total, deceased persons, those who did not give their consent, and minors will not be included.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients admitted to the ICU between January 2021 and December 2023 who have required invasive mechanical ventilation for a period of more than 48 hours. * Patients who give their informed consent to participate in the study. * Patients aged 18 years or older Exclusion Criteria: * Patients who have been subjected to mechanical ventilation for less than 48 hours during their stay in the ICU between January 2021 and December 2023. * Patients who do not give their informed consent and, therefore, do not agree to participate in the interview. * Patients who have died during their stay in the ICU or in the period between 2021 and 2024. * Patients under 18 years of age. * Patients in whom it is not possible to collect all the information necessary to adequately assess post-ICU syndrome.

Primary outcome measure(s)

  • Post-Intensive Care Unit Symptoms — More than 1 year after intensive care unit discharge
    Rate of patients currently suffering of post-intensive care symptoms

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria Las Palmas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06857513 on ClinicalTrials.gov ↗ ← All trials in Spain