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Clinical Trials/NCT05149430
NCT05149430CompletedNot Applicable

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

Sanatorio Anchorena San Martin1 site in 1 country101 target enrollmentStarted: August 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
101
Locations
1
Primary Endpoint
Quality of life

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Quality of life

Time Frame: 2019 - 2020

It is the perception that an individual has of his place in existence, in the context of the culture and the value system in which he lives. This aspect was evaluated using the EuroQol Group EQ-5D-5L (EQ-5D-5L) tool.

Functional capacity

Time Frame: 2019 - 2020

Functional capacity refers to the capability of performing tasks and activities that people find necessary or desirable in their lives. It was assessed using the Barthel Index (IB) tool.

Cognitive status

Time Frame: 2019 - 2020

Cognitive impairment is when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life.. It was evaluated by Fototest, it is a cognitive test, which includes several domains, language (denomination), executive tasks (verbal fluency) and episodic memory either free or facilitated by keys.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sanatorio Anchorena San Martin
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matias Bertozzi

Respiratory Therapy

Sanatorio Anchorena San Martin

Study Sites (1)

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