Clinical and Funtional Caracteristics of Patients Admitted for Severe Pneumonia Due to COVID 19.
NCT ID: NCT06727474
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2020-06-01
2021-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital Nacional Profesor Alejandro Posadas
OTHER
Responsible Party
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Locations
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Ladislao Diaz Ballve
Haedo, Buenos Aires, Argentina
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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01-2024
Identifier Type: -
Identifier Source: org_study_id