Clinical trial NCT06727474: Clinical and Funtional Caracteristics of Patients Admitted for Severe Pneumonia Due to COVID 19.
Official title: Evolution of Quality of Life, Functional Capacity, Nutritional Status and Return to Work Activity in Patients Admitted for Severe Pneumonia Due to COVID 19 Requiring Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-intensive Care Syndrome
COVID-19
Keywords: COVID-19
health-related quality of life
functional capacity
nutritional status
reintegration into work
post-intensive care syndrome
Lead sponsor: Hospital Nacional Profesor Alejandro Posadas
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 51
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: During the period between June and December 2020, all patients who were discharged alive from the ICU, were referred to the general hospitalization ward and were discharged from hospital were included

Brief 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.

Detailed description: This study aims to evaluate the long-term impact of severe COVID-19 pneumonia on patients requiring invasive mechanical ventilation (IMV) for more than 72 hours. Specifically, it examines health-related quality of life (HRQoL), functional capacity, muscle strength, nutritional status, and work reintegration at various time points up to one year after ICU discharge. Additionally, it assesses one-year post-hospital discharge mortality and the time required for patients to return to work.

The study employs a prospective, longitudinal design, following a cohort of patients aged 18 years and older discharged alive from the ICU. Participants were selected based on strict inclusion criteria, such as confirmed COVID-19 pneumonia requiring IMV for over 72 hours and the ability to provide informed consent. Exclusion criteria included cognitive impairment, prior tracheostomy, or pre-existing indications for home mechanical ventilation. The population was evaluated across four defined time points: before hospital discharge (Visit 0), at one month (Visit 1), at six months (Visit 2), and at one year post-discharge (Visit 3).

Clinical, demographic, and functional data were collected through validated tools. HRQoL was assessed using the EQ-5D-3L index and visual analog scale (VAS), while functional capacity was measured with the Katz Index and the Timed Up and Go (TUG) test. Muscle strength was evaluated using the Medical Research Council (MRC) scale, and nutritional status was determined through BMI and anthropometric measurements, including arm, waist, and calf circumferences. Additional data included work reintegration and mortality outcomes, tracked through patient interviews and medical records.

Data analysis employed robust statistical methods to identify trends and differences across time points. Descriptive statistics summarized demographic and baseline clinical characteristics. Longitudinal comparisons were conducted using repeated measures ANOVA or Friedman tests, with post-hoc analysis (Bonferroni or Dunn-Bonferroni) to evaluate significant pairwise differences. For comparisons involving only two time points, paired t-tests or Wilcoxon signed-rank tests were used as appropriate. All analyses adhered to a significance threshold of p \< 0.05, and data visualization was performed using SPSS and R software packages.

Ethical considerations were rigorously maintained. The study was approved by the Ethics Committee of the Hospital Nacional Prof. Alejandro Posadas, and informed consent was obtained from all participants. Patient anonymity was preserved using unique coded identifiers, and all procedures complied with established guidelines for research integrity and participant safety.

Preliminary results indicate significant improvements in HRQoL, functional capacity, and muscle strength over the one-year follow-up period. However, persistent challenges such as delayed work reintegration and moderate mortality rates highlight the complex recovery trajectory of critically ill COVID-19 survivors. This study underscores the importance of structured, multidisciplinary follow-up programs to address the physical, nutritional, and psychosocial needs of this vulnerable population.

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

Primary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: 1 year
measure: Functional capacity
timeFrame: 1 year
measure: Functional capacity
timeFrame: 1 year
measure: Muscle Strength
timeFrame: 1 year
measure: Anthropometric variables - Body mass index
timeFrame: 1 year
measure: Anthropometric variables -
timeFrame: 1 year
measure: Anthropometric variables - Arm Circumference (AC)
timeFrame: 1 year
measure: Anthropometric variables - Calf Circumference (CC)
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients who returned to work
timeFrame: 1 year
measure: Number of Participants Who Died During the One-Year Follow-Up
timeFrame: 1 year
Other outcomes:
Locations:
city: Haedo
country: Argentina
facility: Ladislao Diaz Ballve
state: Buenos Aires
Study officials:
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