Post-Intensive Care SyndromePICUS2NCT06857513
Post-ICU Syndrome Over Time in Patients With Respiratory Failure
An observational study of Post-Intensive Care Syndrome and Quality of Life, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome, Quality of Life
- What is being tested?
- Questionnaire and Physical Exam, EuroQol 5-Dimension 3-Level and EuroQol Visual Analogue Scale (EQ-VAS)
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the ICU between January 2021 and December 2023 undergoing mechanical ventilation for more than 48 hours
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurelio Rodríguez-Pérez, MD PhD contact
Spain1 site
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35002
Ángel Becerra-Bolaños, MD PhD, 676229025, angbecbol@gmail.com
Aurelio Rodríguez-Pérez, MD PhD, arodperp@gobiernodecanarias.org
About this study
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.
Read the detailed description
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
- Post-Intensive Care Syndrome, Quality of Life
- Being tested
- Questionnaire and Physical Exam, EuroQol 5-Dimension 3-Level, EuroQol Visual Analogue Scale (EQ-VAS)
- Keywords
- risk factors, intensive care unit, comorbidities
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDiagnostic test
Patients will be interviewed about the current suffering of post-intensive care symptoms
EuroQol 5-Dimension 3-LevelDiagnostic 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)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"
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from post-intensive care syndrome | Patients suffering from at least one symptom of post-intensive care syndrome Receives: 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 Receives: Diagnostic Test: Questionnaire and Physical Exam; Diagnostic Test: EuroQol 5-Dimension 3-Level; Diagnostic Test: EuroQol Visual Analogue Scale (EQ-VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Intensive Care Unit Symptoms
Rate of patients currently suffering of post-intensive care symptoms
Measured: More than 1 year after intensive care unit discharge
Secondary 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"
Measured: More than 1 year after intensive care unit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857513
- Sponsor's protocol ID
- PICUS-2025
- Acronym
- PICUS2
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ICU Syndrome Over Time in Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT06857513
- Acronym / sponsor ID
- PICUS2 / PICUS-2025
- Conditions
- Post-Intensive Care Syndrome, Quality of Life
- Keywords
- risk factors, intensive care unit, comorbidities
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from 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 suffering from at least one symptom of post-intensive care syndrome |
| Patients not suffering from 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 without any symptom of post-intensive care syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the ICU between January 2021 and December 2023 undergoing mechanical ventilation for more than 48 hours
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamPatients will be interviewed about the current suffering of post-intensive care symptoms | Diagnostic test | Patients not suffering from post-intensive care syndrome, Patients suffering from post-intensive care syndrome |
| EuroQol 5-Dimension 3-Levelto assess health-related quality of life, focusing on the assessment of five key dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression. | Diagnostic test | Patients not suffering from post-intensive care syndrome, Patients suffering from post-intensive care syndrome |
| 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" | Diagnostic test | Patients not suffering from post-intensive care syndrome, Patients suffering from post-intensive care syndrome |
Primary outcome
Post-Intensive Care Unit Symptoms
Time frame: More than 1 year after intensive care unit discharge
Rate of patients currently suffering of post-intensive care symptoms
1 secondary outcome
Quality of life assessment
Time frame: More than 1 year after intensive care unit discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurelio Rodríguez-Pérez, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Intensive Care Syndrome and Quality of Life, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ángel Becerra Bolaños, MD PhD (+34676229025, angbecbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Intensive Care Unit Symptoms (time frame: More than 1 year after intensive care unit discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.