Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic

Completed

Conditions: Covid19
Critical Care
Postintensive Care Syndrome

Interventions: Other: Intensive care unit stay during the COVID-19 pandemic

Registration Number: NCT04979897

Lead Sponsor: Universidad del Desarrollo

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 252

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive care unit stay during low bed occupancy in the COVID-19 pandemic	Intensive care unit stay during the COVID-19 pandemic	Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a low bed occupancy in the pandemic
Intensive care unit stay during high bed occupancy in the COVID-19 pandemic	Intensive care unit stay during the COVID-19 pandemic	Adult patients (≥18 years old) who are mechanically ventilated for at least 48 hours in one of the participating ICUs during a high bed occupancy in the pandemic

Primary Outcome Measures

Name	Time	Method
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	6 months after the ICU discharge	The WHODAS 2.0 is a self-reported disability questionnaire based on the International Classification of Functioning, Disability, and Health (ICF). It includes 36 questions, organised under six domains (cognition, mobility, self-care, getting along, life activities and participation). Each question must be answered based on the perceived difficulty for performing activities using a 5-point scale (none, mild, moderate, severe and extreme). The overall score of each domain, it is transformed into a score between 0 and 100, where 0 means no disability and 100 is complete disability

Secondary Outcome Measures

Name	Time	Method
Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength	Within 72 hours from ICU discharge	the MRC-SS consists of a standardised examination of six muscle groups bilaterally (i.e. shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension and dorsiflexion). All muscle groups are scored using a 6-point scale between 0 and 5 (0 = no visible /palpable contraction; 1 = visible / palpable contraction or no limb movement; 2 = limb movement, but not against gravity; 3 = movement against the gravity over nearly the entire range of motion; 4 = motion against gravity and resistance, subjectively adjusted for gender and age; 5 = normal force). The score goes from 0 (no strength) to a maximum score of 60 points, indicating normal peripheral strength.
Clinical Frailty Scale	Within 72 hours from ICU discharge	The CFS evaluates specific domains including physical functioning, activities of daily living (ADL), instrumental ADL, assistance for personal care, comorbidities, and cognition to generate a frailty score using a 9-point scale ranging from 1 (very fit) to 9 (terminally ill). A score greater than 4 is considered fragile
Survival	6 months after the ICU discharge	Number of patients who survived
Hospital Anxiety and Depression Scale (HADS)	6 months after the ICU discharge	The HADS is an interviewer or self-administered questionnaire designed to identify anxiety and depressive symptoms in a wide variety of in-hospital patients, which requires between 2 and 5 minutes to be completed. The HADS has fourteen questions, seven for anxiety and seven for depressive symptoms. Each question is rated with a 4-point scale ranging from 0 ("absence") to 3 ("extreme presence"), resulting in a sum score of 21 points per subscale. For each subscale, a score \>8 indicates suspected anxiety or depression, while a score \>11 indicates clinical symptoms of anxiety or depression.
Employment Status	6 months after the ICU discharge	The employment status was evaluated using the following questions: What is your current employment status? What working hours do you have? and has your employment situation changed after your ICU stay?
Montreal Cognitive Assessment-Blind (MoCA Blind)	6 months after the ICU discharge	The MoCA blind is a cognitive screening tool designed to detect cognitive dysfunction in five areas: memory, attention, language, abstraction and orientation. Each domain is scored separately for a total score ranging from 0 to 22 points. A score equal to or greater than 18 points is considered normal cognition.
Impact of Events Scale-Revised (IES-R)	6 months after the ICU discharge	The IES-R is an interviewer or self-administered questionnaire designed to measure the subjective distress caused by traumatic events that has been validated for critical illness survivors. It comprises 22 questions in three subscales: intrusion, avoidance, and hyperarousal. Questions are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The score goes from 0 to 88 points. Scores above 33 are indicative of post-traumatic stress symptoms.
Functional Status Score for the Intensive Care Unit (FSS-ICU)	Within 72 hours from ICU discharge	The FSS-ICU is a mobility instrument to score the level of physical assistance required when performing five functional activities: rolling, transfer from supine to sit, sitting at the edge of the bed, transfer from sitting to stand, and walking. Each activity is scored using a 7-point scale ranging from 0 (not able to perform) to 7 (complete independence). The resulting overall score ranges from 0 to 35 points, where a higher scores indicates better performance.
European Quality of Life Health Questionnaire (EQ-5D-3L)	6 months after the ICU discharge	The EQ-5D-3L is an interviewer or self-administered questionnaire of health status or health-related quality of life, including five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and global health state. Each domain is scored based on 3 levels of severity: no problems, some problems, and extreme problems. Each combination of answers can be translated into a utility score, where 0 is similar to being dead and 1 represents the best possible quality of life. The utility scores were obtained using the Chilean Social valuation of EQ-5D health states (DOI: http://dx.doi.org/10.1016/j.jval.2011.09.002)

Trial Locations

Locations (7): Clínica Alemana de Santiago
🇨🇱
Santiago, Chile
Hospital San Pablo de Coquimbo
🇨🇱
Coquimbo, Chile
Hospital del Salvador
🇨🇱
Santiago, Chile
Hospital Metropolitano
🇨🇱
Santiago, Chile
Hospital Regional Dr. Leonardo Guzmán de Antofagasta
🇨🇱
Antofagasta, Chile
Clínica INDISA
🇨🇱
Santiago, Chile
Clínica BUPA
🇨🇱
Santiago, Chile