Post-ICU Syndrome Over Time in Patients With Respiratory Failure

NCT06857513 | Not Yet Recruiting

• 1 other identifier: PICUS-2025
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Intensive Care Syndrome; Quality of Life

Keywords

risk factors; intensive care unit; comorbidities

Outcome Measures

Primary Outcomes (1)

• Post-Intensive Care Unit Symptoms

  Rate of patients currently suffering of post-intensive care symptoms

  More than 1 year after intensive care unit discharge

Secondary Outcomes (1)

• Quality of life assessment

  More than 1 year after intensive care unit discharge

Study Arms (2)

Patients suffering from post-intensive care syndrome

Patients suffering from at least one symptom of post-intensive care syndrome

Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: EuroQol 5-Dimension 3-Level; Diagnostic Test: EuroQol Visual Analogue Scale (EQ-VAS)

Patients not suffering from post-intensive care syndrome

Patients without any symptom of post-intensive care syndrome

Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: EuroQol 5-Dimension 3-Level; Diagnostic Test: EuroQol Visual Analogue Scale (EQ-VAS)

Interventions

Questionnaire and Physical Exam DIAGNOSTIC_TEST

Patients will be interviewed about the current suffering of post-intensive care symptoms

Patients not suffering from post-intensive care syndrome; Patients suffering from post-intensive care syndrome

EuroQol 5-Dimension 3-Level DIAGNOSTIC_TEST

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.

Patients not suffering from post-intensive care syndrome; Patients suffering from post-intensive care syndrome

EuroQol Visual Analogue Scale (EQ-VAS) DIAGNOSTIC_TEST

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"

Patients not suffering from post-intensive care syndrome; Patients suffering from post-intensive care syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in the ICU between January 2021 and December 2023 undergoing mechanical ventilation for more than 48 hours

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35002, Spain

Location

MeSH Terms

Conditions

postintensive care syndrome

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ángel Becerra Bolaños, MD PhD

CONTACT

+34676229025; angbecbol@gmail.com

Aurelio Rodríguez-Pérez, MD PhD

CONTACT

arodperp@gobiernodecanarias.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

ES (1)