Post-ICU Syndrome Over Time in Patients With Respiratory Failure
NCT ID: NCT06857513
Last Updated: 2025-09-08
Study Results
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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NOT_YET_RECRUITING
90 participants
OBSERVATIONAL
2025-10-01
2026-01-30
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
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
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"
Patients not suffering from post-intensive care syndrome
Patients without any symptom of post-intensive care syndrome
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"
Interventions
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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"
Eligibility Criteria
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Inclusion Criteria
* Patients who give their informed consent to participate in the study.
* Patients aged 18 years or older
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Dr. Negrin University Hospital
OTHER
Responsible Party
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Ángel Becerra-Bolaños, MD PhD
Principal Investigator
Locations
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Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PICUS-2025
Identifier Type: -
Identifier Source: org_study_id
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