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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04186611
Other study ID # ERGO-PRE-SI_2019-00867
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date December 6, 2019

Study information

Verified date February 2020
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to assess the feasibility of early daily occupational therapy intervention within an interdisciplinary team in an intensive care unit of a Swiss university hospital.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 6, 2019
Est. primary completion date December 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 18 years old.

- Hospitalized at SMIA for at least 48 hours.

- Stable patient: hemodynamically stabilized patient (norepinephrine dose < 15 mcg/min iv), respiratory (P/F ratio > 150) and neurological (Glasgow Coma Scale > 8).

Exclusion Criteria:

- contraindication to occupational therapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
early occupational therapy
The intervention will be the one usually carried out but earlier and on a daily basis. It will consist of the initial assessment and then positioning and/or carrying out activities of daily living. The daily duration of the intervention will be about 45 minutes to 1 hour. The overall duration of the intervention will be determined according to the objectives and will be at most equal to the time of stay in the intensive care unit.

Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne Canton De Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early daily occupational therapy intervention feasability (case report form with questions to ask) Assess the feasibility of providing early daily occupational therapy interventions in the Adult Intensive Medicine Service of the Centre Hospitalier Universitaire Vaudois within the current interdisciplinary team. Every day, the occupational therapist complete a case report form which say if the intervention can be realise or not in order to find the feasability of a daily early occupationnal therapy intervention. The feasability is mesure every day for each participant until they leave the intensive care unit.
the feasibility assessment contains several elements, including the possibility or not of carrying out the intervention, but also the safety aspect with the collection of possible adverse events.
Up to intensive care unit discharge, estimated as an average of 6 days
Secondary Daily occupational therapy intervention description by completion of case report form Describe the content of the occupational therapy intervention in intensive care unit. Occupational therapists complete a form for each intervention (daily) regarding the type of intervention they have performed with the participants (positioning, daily activities, etc.) until the end of the intervention, when the patient leaves the intensive care unit. Up to intensive care unit discharge, estimated as an average of 6 days
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