Trial Outcomes & Findings for Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic (NCT NCT04979897)

NCT ID: NCT04979897

Last Updated: 2024-07-12

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 252 participants
• Primary outcome timeframe: 6 months after the ICU discharge
• Results posted on: 2024-07-12

Participant Flow

October 20th, 2020 to April 12th, 2021

Not recruited (n=152) * Declined to participate (n=18) * Unable to cooperate (n=40) * Lack of evaluator (n=94)

Participant milestones

Measure	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
Overall Study STARTED	149	103
Overall Study 3-month Follow-up	55	50
Overall Study COMPLETED	30	37
Overall Study NOT COMPLETED	119	66

Reasons for withdrawal

Measure	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
Overall Study Death	1	8
Overall Study Lost to Follow-up	111	56
Overall Study Withdrawal by Subject	7	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=149 Participants 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 n=103 Participants 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	Total n=252 Participants Total of all reporting groups
Age, Continuous	55 years n=149 Participants	61 years n=103 Participants	57 years n=252 Participants
Sex: Female, Male Female	48 Participants n=149 Participants	41 Participants n=103 Participants	89 Participants n=252 Participants
Sex: Female, Male Male	101 Participants n=149 Participants	62 Participants n=103 Participants	163 Participants n=252 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=30 Participants 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 n=37 Participants 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
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	5 units on a scale Interval 2.0 to 18.0	13.5 units on a scale Interval 2.0 to 23.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=149 Participants 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 n=103 Participants 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
Clinical Frailty Scale	2 score on a scale Interval 2.0 to 3.0	3 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=149 Participants 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 n=103 Participants 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
Medical Research Council Sum Score (MRC-SS): Peripheral Muscle Strength	52 score on a scale Interval 46.0 to 57.0	50 score on a scale Interval 44.0 to 57.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=149 Participants 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 n=103 Participants 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
Functional Status Score for the Intensive Care Unit (FSS-ICU)	26 score on a scale Interval 21.0 to 32.0	27 score on a scale Interval 19.0 to 32.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=30 Participants 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 n=37 Participants 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
Montreal Cognitive Assessment-Blind (MoCA Blind)	21 score on a scale Interval 19.0 to 22.0	20 score on a scale Interval 18.0 to 22.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=30 Participants 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 n=37 Participants 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
Hospital Anxiety and Depression Scale (HADS) Depression subscale	7 score on a scale Interval 5.0 to 8.0	7 score on a scale Interval 5.0 to 9.0
Hospital Anxiety and Depression Scale (HADS) Anxiety subscale	6 score on a scale Interval 3.0 to 9.0	7 score on a scale Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=30 Participants 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 n=37 Participants 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
Impact of Events Scale-Revised (IES-R)	13.5 score on a scale Interval 5.0 to 38.0	22 score on a scale Interval 7.0 to 44.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=30 Participants 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 n=37 Participants 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
European Quality of Life Health Questionnaire (EQ-5D-3L)	0.79 score on a scale Interval 0.57 to 1.0	0.74 score on a scale Interval 0.51 to 0.79

SECONDARY outcome

Timeframe: 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?

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=30 Participants 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 n=37 Participants 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
Employment Status No answer	1 Participants	0 Participants
Employment Status Employed-Full time	18 Participants	17 Participants
Employment Status Employed-Part time	3 Participants	3 Participants
Employment Status Umemployed	4 Participants	9 Participants
Employment Status Retired	4 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months after the ICU discharge

Number of patients who survived

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=149 Participants 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 n=103 Participants 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
Survival	148 Participants	95 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Every month during one year

Number of patients who can be contacted and evaluated

Outcome measures

Measure	Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic n=149 Participants 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 n=103 Participants 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
Cohort Retention Rate	30 Participants	37 Participants

Adverse Events

Intensive Care Unit Stay During High Bed Occupancy in the COVID-19 Pandemic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Intensive Care Unit Stay During Low Bed Occupancy in the COVID-19 Pandemic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ana Castro-Avila

Universidad del Desarrollo

Phone: +56223279648

Email: anacastro@udd.cl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place