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

NCT ID: NCT04979897

Last Updated: 2024-07-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Critical Care Postintensive Care Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intensive care unit stay during the COVID-19 pandemic

Intervention Type 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 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

Intensive care unit stay during the COVID-19 pandemic

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intensive care unit stay during the COVID-19 pandemic

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinica Alemana de Santiago

OTHER

Sponsor Role collaborator

Clinica Indisa

OTHER

Sponsor Role collaborator

Clinica Bupa Santiago

OTHER

Sponsor Role collaborator

Hospital del Salvador

OTHER

Sponsor Role collaborator

Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman

OTHER

Sponsor Role collaborator

Hospital San Pablo de Coquimbo

OTHER

Sponsor Role collaborator

Hospital Metropolitano

OTHER

Sponsor Role collaborator

Universidad del Desarrollo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ana Cristina Castro

Visiting lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana Castro-Ávila, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad del Desarrollo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Regional Dr. Leonardo Guzmán de Antofagasta

Antofagasta, , Chile

Site Status

Hospital San Pablo de Coquimbo

Coquimbo, , Chile

Site Status

Clínica Alemana de Santiago

Santiago, , Chile

Site Status

Clínica BUPA

Santiago, , Chile

Site Status

Clínica INDISA

Santiago, , Chile

Site Status

Hospital del Salvador

Santiago, , Chile

Site Status

Hospital Metropolitano

Santiago, , Chile

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Chile

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37972091 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34497087 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-78

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.