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

NCT04979897 | Completed Results

• 1 other identifier: 2020-78
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 7

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.

Conditions

Covid19; Critical Care; Postintensive Care Syndrome

Keywords

Covid19; Critical care; Postintensive Care Syndrome; Rehabilitation; Follow-up

Outcome Measures

Primary Outcomes (1)

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  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

  6 months after the ICU discharge

Secondary Outcomes (9)

• Clinical Frailty Scale

  Within 72 hours from ICU discharge

• Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength

  Within 72 hours from ICU discharge

• Functional Status Score for the Intensive Care Unit (FSS-ICU)

  Within 72 hours from ICU discharge

• Montreal Cognitive Assessment-Blind (MoCA Blind)

  6 months after the ICU discharge

• Hospital Anxiety and Depression Scale (HADS)

  6 months after the ICU discharge

Other Outcomes (1)

• Cohort Retention Rate

  Every month during one year

Study Arms (2)

Intensive care unit stay during high bed occupancy in 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

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

Intensive care unit stay during low bed occupancy in 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

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

Interventions

Intensive care unit stay during the COVID-19 pandemic OTHER

Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open \[close\] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study

Intensive care unit stay during high bed occupancy in the COVID-19 pandemic; Intensive care unit stay during low bed occupancy in the COVID-19 pandemic

Eligibility Criteria

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

Study Population

Adults who were mechanically ventilated in the ICU, either with the diagnosis of COVID-19 or other causes

You may qualify if:

• Adult patients (≥18 years old)
• Mechanically ventilated for at least 48 hours

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Clinica Alemana de Santiago: collaborator
• Clinica Indisa: collaborator
• Clinica Bupa Santiago: collaborator
• Hospital del Salvador: collaborator
• Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman: collaborator
• Hospital San Pablo de Coquimbo: collaborator
• Hospital Metropolitano: collaborator

Study Sites (7)

Hospital Regional Dr. Leonardo Guzmán de Antofagasta

Antofagasta, Chile

Location

Hospital San Pablo de Coquimbo

Coquimbo, Chile

Location

Clínica Alemana de Santiago

Santiago, Chile

Location

Clínica BUPA

Santiago, Chile

Location

Clínica INDISA

Santiago, Chile

Location

Hospital del Salvador

Santiago, Chile

Location

Hospital Metropolitano

Santiago, Chile

Location

Related Publications (2)

• Castro-Avila A, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Munoz-Munoz F, Leppe J; IMPACCT COVID-19 study group. Six-month post-intensive care outcomes during high and low bed occupancy due to the COVID-19 pandemic: A multicenter prospective cohort study. PLoS One. 2023 Nov 16;18(11):e0294631. doi: 10.1371/journal.pone.0294631. eCollection 2023.

  PMID: 37972091 DERIVED

• Castro-Avila AC, Merino-Osorio C, Gonzalez-Seguel F, Camus-Molina A, Leppe J; IMPACCT COVID-19 study group. Impact on Mental, Physical and Cognitive functioning of a Critical care sTay during the COVID-19 pandemic (IMPACCT COVID-19): protocol for a prospective, multicentre, mixed-methods cohort study. BMJ Open. 2021 Sep 8;11(9):e053610. doi: 10.1136/bmjopen-2021-053610.

  PMID: 34497087 DERIVED

Related Links

• Custom-made study web site

MeSH Terms

Conditions

COVID-19; postintensive care syndrome

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

Results Point of Contact

• Title: Ana Castro-Avila
• Organization: Universidad del Desarrollo

anacastro@udd.cl

+56223279648

Study Officials

• Ana Castro-Ávila, PhD

  Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting lecturer

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: July 28, 2021
• Study Start: October 20, 2020
• Primary Completion: November 2, 2021
• Study Completion: September 2, 2022
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-06

Locations

CL (7)