Clinical trial NCT05149430: Quality of Life and Functional Capacity in Post Intensive Care Unit
Official title: Evolution and Follow-up of the Quality of Life and Functional Capacity, in Patients Admitted in Ward Room, Post-hospitality in the Intensive Care Unit. Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-intensive Care Syndrome
Lead sponsor: Sanatorio Anchorena San Martin
Sponsor class: OTHER
Collaborators: name: Cagide Sabrina
name: Di giorgio Victoria
name: Villalba Dario
name: Accoce Matias
First posted: 2021-12-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post ICU patients who entered to the ward room

Brief summary: BACKGROUND. Staying in an intensive care unit can lead to physical and cognitive complications and post-traumatic stress. Currently, the aim is to find out the level of quality of life, functional capacity and cognitive status post intensive care unit. Describe the evolution of the quality of life, functional capacity and cognitive status of a cohort of patients admitted to the ward room after discharge from the intensive care unit, with subsequent follow-up at 3, 6 and 12 months of his discharge.

METHODS. Prospective, observational, analytical cohort study. Subjects over 18 years of age with at least 48 hours of confinement in a closed area were included. Demographic variables, quality of life, functional capacity and cognitive status were recorded. A telephone follow-up was carried out three, six and twelve months after institutional discharge. For the evaluation of the primary variables, Euroqol 5d-5L (Eq5d - Eq5d-VAS), Barthel Index and Fototest were used.


Eligibility criteria: Inclusion Criteria:

* All patients over 18 years old
* At least 48 hours in the ICU
* Who subsequently entered the Clinical Ward Room
* Who signed the informed consent

Exclusion Criteria:

* Those patients who received invasive mechanical ventilation in the last 6 months
* Who had been admitted to an ICU in the last 6 months
* Patients who cannot answer the questionnaires on their own or who do not have relatives to answer them
* Patients with progressive degenerative neurological pathology.
* Patients diagnosed with cancer with a life expectancy of less than 12 months according to the criteria of the oncologist.

Primary outcomes:
measure: Quality of life
timeFrame: 2019 - 2020
measure: Functional capacity
timeFrame: 2019 - 2020
measure: Cognitive status
timeFrame: 2019 - 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Matias Bertozzi
Study officials:
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