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Clinical and Functional Characteristics of Patients Admitted for Severe COVID-19 Pneumonia

CompletedN/A

Sponsor: Hospital Nacional Profesor Alejandro Posadas

Conditions: Post-intensive Care Syndrome, COVID-19

Interventions: Health-Related Quality of Life (HRQoL) with EQ-5D-3L

Countries: Argentina

This research protocol aims to evaluate the impact of severe COVID-19 pneumonia requiring invasive mechanical ventilation (IMV) on health-related quality of life (HRQoL), functional capacity, muscle strength, and nutritional status one year after discharge from the ICU. The study is analytical, longitudinal, and prospective, involving patients over 18 years who received IMV for more than 72 hours and were discharged alive. Primary outcomes include changes in HRQoL (assessed using EQ-5D-3L and VAS), functional capacity (Katz Index and Timed Up and Go test), muscle strength (MRC scale), and nutritional status (BMI and limb circumferences). Secondary outcomes include time to return to work and one-year mortality. Data collection occurs at discharge and at one, six, and twelve months post-discharge. Statistical analyses involve descriptive statistics and longitudinal comparisons using Friedman and Dunn-Bonferroni tests. Ethical approval has been secured, and patient anonymity will be ensured. The protocol emphasizes multidisciplinary follow-up to identify and address physical and psychological sequelae effectively.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* discharged alive from the ICU
* over 18 years of age
* diagnosis of admission or reason for hospitalization in the ICU of pneumonia due to COVID-19, all had to have confirmed the presence of SARS-CoV-2 as a causative agent by a positive result of a real-time reverse transcriptase polymerase chain reaction assay with nasopharyngeal swab samples or tracheal aspirated respiratory airway sample.
* have received invasive mechanical ventilatory assistance for more than 72 hours
* the patient or a close family member had agreed to participate in the study by signing the informed consent.

Exclusion Criteria:

* patients in jail at the time of admission to the ICU.
* history of dementia or cognitive impairment.
* those who already had a previous tracheostomy for any reason
* prior to admission to the ICU indication of prolonged mechanical ventilation at home or in a chronic care institution

Locations (1)

Haedo, Buenos Aires, Argentina