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

NCT06727474 | Completed

• 1 other identifier: 01-2024
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Health-related quality of life (HRQoL)

  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.

  1 year

• Functional capacity

  Measured through 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). Outcome Measure 2: Functional Mobility - Timed Up and 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. Time Frame: Assessed at three time points: at one month, at six months, and one year post-discharge (not applicable before hospital discharge as participants may not be ambulatory).

  1 year

• Functional capacity

  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).

  1 year

• Muscle Strength

  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).

  1 year

• Anthropometric variables - Body mass index

  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.

  1 year

• Anthropometric variables -

  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).

  1 year

• Anthropometric variables - Arm Circumference (AC)

  AC is measured at the midpoint between the acromion and the olecranon. Unit of Measure: Circumference in centimeters (cm).

  1 year

• Anthropometric variables - Calf Circumference (CC)

  CC is measured at the point of maximum circumference of the calf. Unit of Measure: Circumference in centimeters (cm).

  1 year

Secondary Outcomes (2)

• Number of patients who returned to work

  1 year

• Number of Participants Who Died During the One-Year Follow-Up

  1 year

Study Arms (1)

Follow up cohort

Discharged alive from the ICU and admitted to the follow-up program. Programed scheduled visits, which included an evaluation at one month, six months, and one year after hospital discharge

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

Interventions

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

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.

Also known as: 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

Follow up cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Nacional Profesor Alejandro Posadas: lead

Study Sites (1)

Ladislao Diaz Ballve

Haedo, Buenos Aires, 1706, Argentina

Location

Related Publications (9)

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 RESULT

• Demoule A, Morawiec E, Decavele M, Ohayon R, Malrin R, Galarza-Jimenez MA, Laveneziana P, Morelot-Panzini C, Similowski T, De Rycke Y, Gonzalez-Bermejo J. Health-related quality of life of COVID-19 two and 12 months after intensive care unit admission. Ann Intensive Care. 2022 Feb 20;12(1):16. doi: 10.1186/s13613-022-00991-0.

  PMID: 35184214 RESULT

• Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

  PMID: 32644129 RESULT

• Wang X, Xu H, Jiang H, Wang L, Lu C, Wei X, Liu J, Xu S. Clinical features and outcomes of discharged coronavirus disease 2019 patients: a prospective cohort study. QJM. 2020 Sep 1;113(9):657-665. doi: 10.1093/qjmed/hcaa178.

  PMID: 32442308 RESULT

• Pironi L, Sasdelli AS, Ravaioli F, Baracco B, Battaiola C, Bocedi G, Brodosi L, Leoni L, Mari GA, Musio A. Malnutrition and nutritional therapy in patients with SARS-CoV-2 disease. Clin Nutr. 2021 Mar;40(3):1330-1337. doi: 10.1016/j.clnu.2020.08.021. Epub 2020 Aug 27.

  PMID: 32900518 RESULT

• Whittle J, Molinger J, MacLeod D, Haines K, Wischmeyer PE; LEEP-COVID Study Group. Persistent hypermetabolism and longitudinal energy expenditure in critically ill patients with COVID-19. Crit Care. 2020 Sep 28;24(1):581. doi: 10.1186/s13054-020-03286-7. No abstract available.

  PMID: 32988390 RESULT

• Alvarez-Hernandez J, Matia-Martin P, Cancer-Minchot E, Cuerda C; NUTRICOVID study group of SENDIMAD. Long-term outcomes in critically ill patients who survived COVID-19: The NUTRICOVID observational cohort study. Clin Nutr. 2023 Oct;42(10):2029-2035. doi: 10.1016/j.clnu.2023.08.008. Epub 2023 Aug 16.

  PMID: 37659250 RESULT

• Kamdar BB, Suri R, Suchyta MR, Digrande KF, Sherwood KD, Colantuoni E, Dinglas VD, Needham DM, Hopkins RO. Return to work after critical illness: a systematic review and meta-analysis. Thorax. 2020 Jan;75(1):17-27. doi: 10.1136/thoraxjnl-2019-213803. Epub 2019 Nov 8.

  PMID: 31704795 RESULT

• Das Neves AV, Vasquez DN, Loudet CI, Intile D, Saenz MG, Marchena C, Gonzalez AL, Moreira J, Reina R, Estenssoro E. Symptom burden and health-related quality of life among intensive care unit survivors in Argentina: A prospective cohort study. J Crit Care. 2015 Oct;30(5):1049-54. doi: 10.1016/j.jcrc.2015.05.021. Epub 2015 Jun 3.

  PMID: 26105747 RESULT

MeSH Terms

Conditions

postintensive care syndrome; COVID-19

Interventions

Visual Analog Scale

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 11, 2024
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: April 1, 2021
• Last Updated: April 17, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year after finalization
• Access Criteria: contact principal investigator via e-mail

Locations

AR (1)