This research protocol aims to evaluate the impact of severe COVID-19 pneumonia requiringinvasive mechanical ventilation (IMV) on health-related quality of life (HRQoL),functional capacity, muscle strength, and nutritional status one year after dischargefrom the ICU. The study is analytical, longitudinal, and prospective, involving patientsover 18 years who received IMV for more than 72 hours and were discharged alive. Primaryoutcomes 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 nutritionalstatus (BMI and limb circumferences). Secondary outcomes include time to return to workand one-year mortality. Data collection occurs at discharge and at one, six, and twelvemonths post-discharge. Statistical analyses involve descriptive statistics andlongitudinal comparisons using Friedman and Dunn-Bonferroni tests. Ethical approval hasbeen secured, and patient anonymity will be ensured. The protocol emphasizesmultidisciplinary follow-up to identify and address physical and psychological sequelaeeffectively.
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.
Diagnostic Test: Health-Related Quality of Life (HRQoL) with EQ-5D-3L
The EQ-5D-3L and EQ-VAS questionnaires, administered at all visits, evaluated five
dimensions: mobility, self-care, daily activities, pain/discomfort, and
anxiety/depression. Responses generated a Health Status sequence and calculated the
EQ-5D-3L Index. A visual analogue scale (VAS) rated health from 0 (worst) to 100 (best).
Functional capacity was assessed using the Katz Index (IK) and Timed Up and Go (TUG),
which measured the time to rise from a chair, walk 3 meters, and return. Anthropometric
variables, measured by the same researcher (LP) at 1 month and 1 year, included limb
circumferences using specific techniques. Muscle strength, evaluated with the EF-MRC
scale, involved verbal commands for movement tests. Calf circumference was measured on
the largest circumference area. Living conditions and work reintegration were recorded.
Health issues detected during follow-up were referred to the clinic's coordinating
physician for appropriate care.
Other Name: EuroQol-5D VAS (Analog visual scale),Medical Reseacrh Council Strength Scale,Katz index for functional independence,Timed Up to Go test,Waist Circunference,Brachial Circumference,Calf Circumference
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
Ladislao Diaz Ballve
Haedo 3430835, Buenos Aires 3435907, Argentina
Not Provided