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Completed

NCT Number: NCT05149430

Quality of Life and Functional Capacity in Post Intensive Care Unit

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.

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Key information

Conditions

Post-Intensive Care Syndrome postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Matias Bertozzi

Buenos Aires, 1406, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational Quality of life and functional capacity

Other

Observational Quality of life and functional capacity

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Sanatorio Anchorena San Martin

Other

Collaborators

  • Accoce Matias
  • Cagide Sabrina
  • Di giorgio Victoria
  • Villalba Dario

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 8, 2021
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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