Clinical and Functional Characteristics of Patients Admitted for Severe COVID-19 Pneumonia (NCT06727474) | Clinical Trial Compass
CompletedNot Applicable
Clinical and Functional Characteristics of Patients Admitted for Severe COVID-19 Pneumonia
Argentina51 participantsStarted 2020-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is already completed and looked at long-term outcomes like quality of life and muscle strength in people who had severe COVID-19 pneumonia, could you help me understand what the findings might mean for my own recovery or follow-up care?
2This trial focused on Post-Intensive Care Syndrome — if I was admitted to the ICU with severe COVID-19, am I at risk for this syndrome, and should we be monitoring my muscle strength and physical function the way this study did?
3The study tracked body measurements like arm and calf circumference alongside functional capacity — are these kinds of measurements something we should be doing regularly to track my recovery from severe COVID-19?
4Because this was an observational study that collected data rather than tested a new treatment, does the information it gathered change any of the standard rehabilitation or follow-up recommendations you'd make for someone in my situation?
5Given that this trial is completed, is there published data from it that you think is relevant to my case, and are there any active follow-up studies or rehabilitation programs based on similar research that might be worth exploring?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.