Critical IllnessNCT04819529
Early and Intensive Occupational Therapy in Mechanical Ventilated Patients
A study testing Early and Intensive Occupational Therapy in people with Critical Illness and Ventilator Lung, run by University of Chile at 1 site in Chile.
Trial summary
This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Ventilator Lung, Impairment, Cognitive
- What is being tested?
- Early and Intensive Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChile
- Study dates
- 20 Jan 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years.
- Need for hospitalization in ICU.
- At least 12 h of invasive mechanical ventilation
- Informed consent signed by legal representative and / or patient.
Who cannot join
- Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores> 3.3 were excluded.
- Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as > 6 points.
- Severe communication disorder and cultural limitation of language (language different from Spanish)
- Patient with limited therapeutic proportionality.
- Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
- Spinal injury or unstable fractures that limit mobilization
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
University of Chile
Santiago, Santiago Metropolitan
Eduardo Tobar, MD, +56229786009, etobar@hcuch.cl
Eduardo Tobar, MD
About this study
Official title: Early and Intensive Occupational Therapy Improves the Functional Status of Critical Patients Undergoing Mechanical Ventilation at Discharge: Randomized Clinical Trial
This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge.
Read the detailed description
A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.
A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early and intensive OT plus ASDM.
The intervention group will receive 20 OT sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition
- Being tested
- Early and Intensive Occupational Therapy
- Medical subject headings
- Critical Illness, Cognitive Dysfunction, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early and Intensive Occupational TherapyBehavioural
Occupational therapists will implement the following activities:
- Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 1 one session each 48 h and SAS 2 one session each 24 h.
- Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered
- Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5
- Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas
- Education: daily visits by trained family members and health staff about the intervention process
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - Early and intensive Occupational Therapy | Experimental | These sessions will be implemented by occupational therapists trained in ICU, who will conduct 20 sessions of 30 min, distributed depending on the level of sedation, i) SAS (Sedation-Agitation Scale) 1 patients have one session each 48 h, evaluating the change of sedation level each 24 h; ii) SAS 2 patients have one session each 24 h, iii) SAS 3-5 have two sessions every day. The sessions will begin once the patient needs mechanical ventilation for at least 12 h Receives: Behavioral: Early and Intensive Occupational Therapy |
| Control group - Standard Analgesia,Sedation, Delirium and Mobilization (ASDM) Protocol | No intervention | The ASDM protocol will be implemented to mechanically ventilated patients in the ICU, following the aspects recommended by experts and the current evidence. For this, the team of medical, nurses, and physiotherapist will be trained to understand and facilitate the ASDM actions that each one must implement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at hospital discharge
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Secondary outcomes (9)
Delirium-free days
CAM-ICU (Confusion Assessment Method Intensive Care Unit) instrument will be applied once a day by evaluator
Measured: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Coma-free days
SAS (Sedation-Agitation Scale) instrument will be applied once a day by evaluator. If SAS 1-2: coma day
Measured: Defined as the number of days in the first 14 days with the SAS.
Delirium-coma free days
SAS and CAM-ICU instruments will be applied once a day by evaluator. Every day without coma or delirium its an delirium-coma free day
Measured: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Hazard ratio for delirium in the interventional versus control group
A composite analysis who involves delirium-coma free days to day 14. Hazard Ratio <1 interpreted as a lower daily hazard of delirium - implying a shorter mean duration of delirium among days at risk for delirium
Measured: Collecting from the first 14 days with the CAM-ICU instrument and coma.
Cognitive status of patients
MoCA (Montreal Cognitive Assessment) instrument (cognitive status).This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Motor status of patients
Grip strength (motor status) with dynamometer will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Quality of life of patients
EQ-5D-5L (Euro Qol 5 dimensions 5 level) will be applied by evaluator. It will be considered a cut-off point in the Chilean population
Measured: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Mental health
Hospital Anxiety and Depression Scale (HADS) will be applied by evaluator. This scale shows that lower score is better, which will be compared between control and experimental group
Measured: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Functional independence
The FIM (Functional independence measure) instrument will be applied by evaluator. This scale shows that higher score is better, which will be compared between control and experimental group
Measured: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Jan 2021
- Primary completion20 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A control group (standard ASDM measures) or an intervention group (early and intensive occupational therapy + ASDM) will be randomized. The intervention group will receive 20 occupational therapy sessions. The interventions will be organized on the basis of i) level of sedation, ii) presence or absence of delirium (according to CAM ICU +/- (Confusion Assessment Method Intensive Care Unit)), iii) movement with or without gravity (cut-off point 3 points in elbow flexion movement in Medical Research Council(MRC)). The areas of intervention implemented by occupational therapist will be: i) Polysensory stimulation, ii) Cognitive stimulation, iii) Basic activities of daily living, iv) Motor function stimulation, v) Education
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse
- Responsible party
- Principal investigator, Eduardo Tobar, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819529
- Sponsor's protocol ID
- SA19I0138
- Status last verified
- May 2021
- First submitted
- 3 Mar 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmerman JE, Kramer AA, Knaus WA. Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012. Crit Care. 2013 Apr 27;17(2):R81. doi: 10.1186/cc12695.
PubMed 23622086Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
PubMed 24638143van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Functional status after intensive care: a challenge for rehabilitation professionals to improve outcome. J Rehabil Med. 2009 Apr;41(5):360-6. doi: 10.2340/16501977-0333.
PubMed 19363570Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379Marra A, Ely EW, Pandharipande PP, Patel MB. The ABCDEF Bundle in Critical Care. Crit Care Clin. 2017 Apr;33(2):225-243. doi: 10.1016/j.ccc.2016.12.005.
PubMed 28284292Costigan FA, Duffett M, Harris JE, Baptiste S, Kho ME. Occupational Therapy in the ICU: A Scoping Review of 221 Documents. Crit Care Med. 2019 Dec;47(12):e1014-e1021. doi: 10.1097/CCM.0000000000003999.
PubMed 31738741Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
PubMed 19446324Sacanella E, Perez-Castejon JM, Nicolas JM, Masanes F, Navarro M, Castro P, Lopez-Soto A. Functional status and quality of life 12 months after discharge from a medical ICU in healthy elderly patients: a prospective observational study. Crit Care. 2011;15(2):R105. doi: 10.1186/cc10121. Epub 2011 Mar 28.
PubMed 21443796Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10.
PubMed 27660922Alvarez E, Garrido M, Salech F, Rojas V, Jara N, Farias JI, Ponce D, Tobar E. Early occupational therapy in mechanically ventilated patients improves functional status: Study protocol. Br J Occup Ther. 2023 Nov;86(11):728-739. doi: 10.1177/03080226231184992. Epub 2023 Jul 14.
PubMed 40336796
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Intensive Occupational Therapy Improves the Functional Status of Critical Patients Undergoing Mechanical Ventilation at Discharge: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04819529
- Acronym / sponsor ID
- SA19I0138
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Hospital Base Valdivia, Hospital Santiago Oriente - Dr. Luis Tisné Brousse
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of an early and intensive occupational therapy (OT) protocol in critical adult patients requiring mechanical ventilation. Evaluating the functional independence at hospital discharge.
Detailed description
A randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 Chilean hospitals.
A control group will has a standard analgesia, sedation, delirium and mobilization (ASDM) measures or an intervention group will have early and intensive OT plus ASDM.
The intervention group will receive 20 OT sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A control group (standard ASDM measures) or an intervention group (early and intensive occupational therapy + ASDM) will be randomized. The intervention group will receive 20 occupational therapy sessions. The interventions will be organized on the basis of i) level of sedation, ii) presence or absence of delirium (according to CAM ICU +/- (Confusion Assessment Method Intensive Care Unit)), iii) movement with or without gravity (cut-off point 3 points in elbow flexion movement in Medical Research Council(MRC)). The areas of intervention implemented by occupational therapist will be: i) Polysensory stimulation, ii) Cognitive stimulation, iii) Basic activities of daily living, iv) Motor function stimulation, v) Education
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Early and intensive Occupational Therapy | Experimental | Behavioral: Early and Intensive Occupational TherapyThese sessions will be implemented by occupational therapists trained in ICU, who will conduct 20 sessions of 30 min, distributed depending on the level of sedation, i) SAS (Sedation-Agitation Scale) 1 patients have one session each 48 h, evaluating the change of sedation level each 24 h; ii) SAS 2 patients have one session each 24 h, iii) SAS 3-5 have two sessions every day. The sessions will begin once the patient needs mechanical ventilation for at least 12 h |
| Control group - Standard Analgesia,Sedation, Delirium and Mobilization (ASDM) Protocol | No intervention | –The ASDM protocol will be implemented to mechanically ventilated patients in the ICU, following the aspects recommended by experts and the current evidence. For this, the team of medical, nurses, and physiotherapist will be trained to understand and facilitate the ASDM actions that each one must implement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal to or greater than 18 years.
- Need for hospitalization in ICU.
- At least 12 h of invasive mechanical ventilation
- Informed consent signed by legal representative and / or patient.
Key exclusion criteria (6 listed)
- Known cognitive impairment before admission with short IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly) Scores> 3.3 were excluded.
- Previous functional impairment, FAQ (Functional Activities Questionnaire) defined as > 6 points.
- Severe communication disorder and cultural limitation of language (language different from Spanish)
- Patient with limited therapeutic proportionality.
- Neurocritical patients (moderate-severe Traumatic Brain Injury / stroke of some kind / among others)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early and Intensive Occupational TherapyOccupational therapists will implement the following activities: * Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 1 one session each 48 h and SAS 2 one session each 24 h. * Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered * Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5 * Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas * Education: daily visits by trained family members and health staff about the intervention process | Behavioural | Experimental Group - Early and intensive Occupational Therapy |
Primary outcome
Functional independence at hospital discharge
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
The FIM (Functional independence measure) instrument will be applied by evaluator team. This scale shows that higher score is better, which will be compared between control and experimental group
9 secondary outcomes
Delirium-free days
Time frame: Defined as the number of days in the first 14 days with the CAM-ICU instrument negative and non-coma day.
Coma-free days
Time frame: Defined as the number of days in the first 14 days with the SAS.
Delirium-coma free days
Time frame: Defined as the number of days in the first 14 days with the SAS and CAM-ICU
Hazard ratio for delirium in the interventional versus control group
Time frame: Collecting from the first 14 days with the CAM-ICU instrument and coma.
Cognitive status of patients
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation and day 90 (+/- 7 days)after hospital discharge
Motor status of patients
Time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation
Quality of life of patients
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Mental health
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Functional independence
Time frame: Day 90 (+/- 7 days) from beginning of mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Background: PubMed 23622086Zimmerman JE, Kramer AA, Knaus WA. Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012. Crit Care. 2013 Apr 27;17(2):R81. doi: 10.1186/cc12695.
- Background: PubMed 24638143Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
- Background: PubMed 19363570van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Functional status after intensive care: a challenge for rehabilitation professionals to improve outcome. J Rehabil Med. 2009 Apr;41(5):360-6. doi: 10.2340/16501977-0333.
- Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Background: PubMed 28284292Marra A, Ely EW, Pandharipande PP, Patel MB. The ABCDEF Bundle in Critical Care. Crit Care Clin. 2017 Apr;33(2):225-243. doi: 10.1016/j.ccc.2016.12.005.
- Background: PubMed 31738741Costigan FA, Duffett M, Harris JE, Baptiste S, Kho ME. Occupational Therapy in the ICU: A Scoping Review of 221 Documents. Crit Care Med. 2019 Dec;47(12):e1014-e1021. doi: 10.1097/CCM.0000000000003999.
- Results publication: PubMed 19446324Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
- Results publication: PubMed 21443796Sacanella E, Perez-Castejon JM, Nicolas JM, Masanes F, Navarro M, Castro P, Lopez-Soto A. Functional status and quality of life 12 months after discharge from a medical ICU in healthy elderly patients: a prospective observational study. Crit Care. 2011;15(2):R105. doi: 10.1186/cc10121. Epub 2011 Mar 28.
- Results publication: PubMed 27660922Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10.
- Derived from this study: PubMed 40336796Alvarez E, Garrido M, Salech F, Rojas V, Jara N, Farias JI, Ponce D, Tobar E. Early occupational therapy in mechanically ventilated patients improves functional status: Study protocol. Br J Occup Ther. 2023 Nov;86(11):728-739. doi: 10.1177/03080226231184992. Epub 2023 Jul 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early and Intensive Occupational Therapy in people with Critical Illness and Ventilator Lung, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Tobar, MD (+56229786009, etobar@hcuch.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at hospital discharge (time frame: Day 28 (+/- 3 days) from beginning of mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819529, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.