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Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation

12 april 2021 uppdaterad av: Maria Natividad Seisdedos Nunez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study

Little is known about the physical function outcomes in patients with severe COVID-19 patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation. The purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

DESIGN: An observation cohort study conducted in a tertiary hospital.

METHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.

Outcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.

SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials.

Studietyp

Observationell

Inskrivning (Faktisk)

71

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
      • Madrid, Spanien, 28034
        • Medical ICU. Hospital Universitario Ramón y Cajal
      • Madrid, Spanien, 28034
        • Surgical ICU. Hospital Universitario Ramón y Cajal

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.

Beskrivning

Inclusion Criteria:

  • subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation;
  • have received invasive ventilation > 24 hours;
  • have been successfully weaned from mechanical ventilation > 48 hours;
  • were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise.

Exclusion Criteria:

  • subjects or proxies with inability to communicate in Spanish fluently;
  • cognitive impairment prior to ICU admission;
  • proven neurological impairment or neuromuscular disorder;
  • Cerebrovascular Accident during hospital stay;
  • previous organ transplant;
  • pregnancy;
  • unstable fractures or any other injuries that would require medical bed rest.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Medical Research Council sum score (MRC- SS).
Tidsram: < 48 hours before ICU discharge
Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
< 48 hours before ICU discharge
Medical Research Council sum score (MRC- SS).
Tidsram: < 24 hours before hospital discharge
Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body.
< 24 hours before hospital discharge
The Functional Status Score for the ICU (FSS-ICU)
Tidsram: < 24 hours before hospital discharge
The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks. Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning.
< 24 hours before hospital discharge

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Age
Tidsram: Through study completion, up to 6 months
Age in years
Through study completion, up to 6 months
Sex
Tidsram: Throughout study completion , up to 6 month
Male vs Female
Throughout study completion , up to 6 month
Body Mass Index
Tidsram: Throughout study completion, up to 6 months
kg/m2
Throughout study completion, up to 6 months
Baseline mobility
Tidsram: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
Baseline mobility
First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
APACHE II score
Tidsram: <24 hours after ICU admission
Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.
<24 hours after ICU admission
Length of stay in ICU
Tidsram: Throughout the study completion, up to 6 months
Number of days of stay in ICU
Throughout the study completion, up to 6 months
Number of days on mechanical ventilation
Tidsram: Throughout the study completion, up to 6 months
Number of days on mechanical ventilation
Throughout the study completion, up to 6 months
Polyneuropathy diagnosis
Tidsram: Throughout the study completion, up to 6 months
Clinical or EMG polyneuropathy diagnosis confirmation
Throughout the study completion, up to 6 months
Number of days on Neuromuscular Blockers
Tidsram: Throughout the study completion, up to 6 months
Number of days on NMB during mechanical ventilation
Throughout the study completion, up to 6 months
Episodes of prone positioning
Tidsram: Throughout the study completion, up to 6 months
Number of prone positioning episodes during ICU stay
Throughout the study completion, up to 6 months
Length of stay in hospital
Tidsram: Throughout the study completion, up to 6 months
Total number of days admitted to hospital
Throughout the study completion, up to 6 months
Continuation of care
Tidsram: Throughout the study completion, up to 6 months
Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.
Throughout the study completion, up to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 maj 2020

Primärt slutförande (Faktisk)

25 februari 2021

Avslutad studie (Faktisk)

1 mars 2021

Studieregistreringsdatum

Först inskickad

20 maj 2020

Först inskickad som uppfyllde QC-kriterierna

21 maj 2020

Första postat (Faktisk)

22 maj 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 april 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 april 2021

Senast verifierad

1 april 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 165/20

Plan för individuella deltagardata (IPD)

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