Post-ICU Syndrome Over Time in Patients With Respiratory Failure

NCT ID: NCT06857513

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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Advances in intensive care have improved short-term survival rates, but survivors of prolonged ICU stays may face medium- and long-term morbidities, influenced by both the critical illness and the ICU environment. This highlights the importance of a comprehensive approach to their care, focused on improving post-ICU quality of life.

Post-intensive care syndrome is defined as the appearance or worsening of physical, cognitive and/or mental health impairments in patients who survive a stay in an ICU. This syndrome usually manifests during the first 48 hours after admission or after discharge, persisting in the long term and negatively affecting quality of life and daily functionality. In the physical field, is characterized by acquired neuromuscular weakness that frequently limits the patient's autonomy. Regarding psychological dysfunction, disorders such as anxiety, depression and post-traumatic stress disorder are observed; in the neurocognitive field, dysfunctions in memory, attention and executive functions affect daily life. 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.

Specific objectives:

* To establish the incidence of PICUS in patients admitted to the ICU for respiratory failure between January 2021 and December 2024.
* To identify the risk factors associated with the development of post-ICU syndrome in these patients, considering both clinical and sociodemographic factors.
* To evaluate the impact of post-ICU syndrome on the quality of life of patients over time, studying the physical, cognitive and psychological consequences of the syndrome.
* To explore the impact on their families, analyzing the emotional impact and the quality of life of caregivers.

This is a cross-sectional study, in which no experimental intervention will be carried out on the patients.

The study population will be patients hospitalized in the Intensive Care Unit between January 2021 and December 2024 undergoing mechanical ventilation for more than 48 hours. Deceased persons, those who did not give their consent, and minors will not be included. The final sample size is expected to be representative for the purposes of the study.

Data collection will be carried out through interviews in 2025, which will allow obtaining detailed information on the current situation of these patients about the presence of symptoms as a consequence of their stay in the ICU more than two years ago.

Conditions

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Post-Intensive Care Syndrome Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients suffering from post-intensive care syndrome

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

Questionnaire and Physical Exam

Intervention Type DIAGNOSTIC_TEST

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

EuroQol 5-Dimension 3-Level

Intervention Type 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.

EuroQol Visual Analogue Scale (EQ-VAS)

Intervention Type 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 without any symptom of post-intensive care syndrome

Questionnaire and Physical Exam

Intervention Type DIAGNOSTIC_TEST

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

EuroQol 5-Dimension 3-Level

Intervention Type 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.

EuroQol Visual Analogue Scale (EQ-VAS)

Intervention Type 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"

Interventions

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Questionnaire and Physical Exam

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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"

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Countries

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Spain

Central Contacts

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Ángel Becerra Bolaños, MD PhD

Role: CONTACT

+34676229025

Aurelio Rodríguez-Pérez, MD PhD

Role: CONTACT

Facility Contacts

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Ángel Becerra-Bolaños, MD PhD

Role: primary

676229025

Aurelio Rodríguez-Pérez, MD PhD

Role: backup

Other Identifiers

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PICUS-2025

Identifier Type: -

Identifier Source: org_study_id

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