N/A
N=252
Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
Covid19 · Critical Care · Postintensive Care Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04979897 ↗Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) — 5; 13.5 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Intensive care unit stay during the COVID-19 pandemic (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad del Desarrollo
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
5; 13.5 | — |
| SECONDARY Clinical Frailty Scale |
2; 3 | — |
| SECONDARY Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength |
52; 50 | — |
| SECONDARY Functional Status Score for the Intensive Care Unit (FSS-ICU) |
26; 27 | — |
| SECONDARY Montreal Cognitive Assessment-Blind (MoCA Blind) |
21; 20 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
7; 7; 6; 7 | — |
| SECONDARY Impact of Events Scale-Revised (IES-R) |
13.5; 22 | — |
| SECONDARY European Quality of Life Health Questionnaire (EQ-5D-3L) |
0.79; 0.74 | — |
| SECONDARY Employment Status |
18; 17; 3; 3; 4; 9 | — |
| SECONDARY Survival |
148; 95 | — |
Summary
Intensive care unit (ICU) survivors and their families frequently present mental, cognitive and physical impairments lasting years. The ongoing pandemic could affect the duration, variety, and severity of these impairments. Our aim is to determine the impact of the COVID-19 pandemic on the physical, mental, and cognitive health of survivors, the experience of their families and their treating healthcare professionals in the long-term.
This is a prospective, multicentre, mixed-methods cohort study in seven Chilean ICUs. The perceptions of family members regarding the ICU stay and the later recovery will be explored 3 months after discharge. Health care professionals will be invited to discuss the challenges faced during the pandemic using semi-structured interviews.
Eligibility Criteria
Inclusion Criteria
- Adult patients (≥18 years old)
- Mechanically ventilated for at least 48 hours
Exclusion Criteria
- Unable to walk independently 2 weeks prior to ICU admission (with or without a gait aid)
- S5q < 5 or CAM-ICU positive within 72 hours after ICU discharge
- Patient who do not understand or speak Spanish
- Patient unable to communicate verbally
- Burn or severe trauma as admission diagnosis
- Any neurological disorder (i.e. spinal cord injury, stroke and brain tumours) as admission diagnosis
- Transferred to a non-participating study centre before ICU discharge assessment
- Recent prolonged hospital stay (extended by more than 3 months)
Data sourced from ClinicalTrials.gov (NCT04979897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.