Post-ICU Syndrome Over Time in Patients With Respiratory Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Negrin University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients hospitalized in the ICU between January 2021 and December 2023 undergoing mechanical ventilation for more than 48 hours
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Questionnaire and Physical Exam
Diagnostic testPatients will be interviewed about the current suffering of post-intensive care symptoms
EuroQol 5-Dimension 3-Level
Diagnostic testto 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)
Diagnostic testrecords the patient's self-rated health on a vertical visual analogue scale where endpoints are labelled: 0 "best imaginable health" - 100 "worst imaginable health"
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Patients suffering from post-intensive care syndrome3 interventions
Group B: Patients not suffering from post-intensive care syndrome3 interventions
Trial outcomes
Primary outcomes
1
Post-Intensive Care Unit Symptoms
Rate of patients currently suffering of post-intensive care symptoms
Time frame
More than 1 year after intensive care unit dischargeSecondary outcomes
1
Quality of life assessment
patient's self-rated health on a vertical visual analogue scale where endpoints are labelled: 0 "best imaginable health" - 100 "worst imaginable health"
Time frame
More than 1 year after intensive care unit dischargeSponsors and contacts
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Source ClinicalTrials.gov
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