Clinical and Funtional Caracteristics of Patients Admitted for Severe Pneumonia Due to COVID 19.

Completed

• Conditions: Post-intensive Care Syndrome; COVID-19

• Registration Number: NCT06727474
• Lead Sponsor: Hospital Nacional Profesor Alejandro Posadas

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life (HRQoL)	1 year	The percentage of change in health-related quality of life (HRQoL) will be measured. This is a multidimensional concept that assesses the physical, psychological and social aspects of an individual's well-being, specifically as it is influenced by their health status.; This study assesses health-related quality of life using the EuroQol-5 Dimension 3 Level (EQ-5D-3L) questionnaire. The EQ-5D-3L includes a descriptive system that covers five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (VAS) that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).; Unit of measurement: EQ-5D-3L Index: a calculated score derived from the descriptive system that reflects overall health-related quality of life.; EQ-5D VAS: a self-reported numerical score that represents perceived health status.
Functional capacity	1 year	Measured through Time up to go (TUG) test. The TUG test measures functional mobility by recording the time (in seconds) it takes for a participant to stand from a seated position, walk 3 meters, turn around, walk back, and sit down.; Unit of Measure: Time in seconds. The Katz Index assesses functional independence in six basic activities of daily living: bathing, dressing, toileting, transferring, continence, and feeding.; Unit of Measure: Score on the Katz Index (range 0-6, where 6 indicates full independence).
Muscle Strength	1 year	Measured through Medical Research Council (MRC) Strength Scale: The MRC Strength Scale evaluates muscle strength across six muscle groups in both upper and lower limbs. Each group is scored on a 6-point scale ranging from 0 (no movement) to 5 (normal strength), with a total score ranging from 0 to 60.; Unit of Measure: Total score on the MRC Strength Scale (range 0-60, where higher scores indicate better muscle strength).
Anthropometric variables - Body mass index	1 year	current Weight in kilograms (kg) and Height in meters (m) for calculation of body mass index (BMI). BMI is calculated as weight (kg) divided by height squared (m²).; Unit of Measure: BMI in kg/m².
Anthropometric variables -	1 year	WC is measured using a non-stretchable measuring tape at the midpoint between the last rib and the iliac crest.; Unit of Measure: Circumference in centimeters (cm).
Anthropometric variables - Arm Circumference (AC)	1 year	AC is measured at the midpoint between the acromion and the olecranon. Unit of Measure: Circumference in centimeters (cm).
Anthropometric variables - Calf Circumference (CC)	1 year	CC is measured at the point of maximum circumference of the calf. Unit of Measure: Circumference in centimeters (cm).

Secondary Outcome Measures

Name	Time	Method
Number of patients who returned to work	1 year	patients who had stated that they had been working prior to hospitalization were asked about the return to work.; Unit of Measure: Number of participants (count).
Number of Participants Who Died During the One-Year Follow-Up	1 year	Mortality was determined by reviewing medical records and contacting patients or their families if they missed a scheduled clinic visit. The reason for non-attendance was investigated, and deaths were recorded when confirmed.; Unit of Measure: Number of participants (count).

Trial Locations

Locations (1)

Ladislao Diaz Ballve; 🇦🇷 Haedo, Buenos Aires, Argentina