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
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View full resultsBasic Information
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COMPLETED
252 participants
OBSERVATIONAL
2020-10-20
2022-09-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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
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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
Eligibility Criteria
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Inclusion Criteria
* Mechanically ventilated for at least 48 hours
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Clinica Alemana de Santiago
OTHER
Clinica Indisa
OTHER
Clinica Bupa Santiago
OTHER
Hospital del Salvador
OTHER
Hospital Clínico Regional De Antofagasta Dr Leonardo Guzman
OTHER
Hospital San Pablo de Coquimbo
OTHER
Hospital Metropolitano
OTHER
Universidad del Desarrollo
OTHER
Responsible Party
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Ana Cristina Castro
Visiting lecturer
Principal Investigators
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Ana Castro-Ávila, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad del Desarrollo
Locations
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Hospital Regional Dr. Leonardo Guzmán de Antofagasta
Antofagasta, , Chile
Hospital San Pablo de Coquimbo
Coquimbo, , Chile
Clínica Alemana de Santiago
Santiago, , Chile
Clínica BUPA
Santiago, , Chile
Clínica INDISA
Santiago, , Chile
Hospital del Salvador
Santiago, , Chile
Hospital Metropolitano
Santiago, , Chile
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Custom-made study web site
Other Identifiers
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2020-78
Identifier Type: -
Identifier Source: org_study_id
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