Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2003-04-30
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Interventions
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SOMA safe enclosure
Eligibility Criteria
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Inclusion Criteria
2. hospitalized
3. acute confusion or agitation
Exclusion Criteria
2. Patients who have a documented history of claustrophobia
3. Patients or family members who refuse to consent for safety net treatment under any circumstances. Failure to obtain consent due to absence of or inability to reach a family member or to give consent to participate in the study
4. Failure to obtain consent due to absence of or inability to reach a family member within reasonable time or to give consent to participate in the study.
5. Acutely ill patients requiring intravenous vasopressors, intubation or ventilatory support
6. Other conditions deemed terminal within 24 hours as determined by the patient's attending physician
7. Patients who stay less than 24 hours in the hospital
8. If patient is already on restrains for more than 48 hours preceding enrollment.
9. If two or more limbs are already on restraint to protect IV lines.
10. Extreme degree of agitation requiring continuous IV sedation or anesthesia. Such patients may pose a danger to staff or themselves if their restraints were to be discontinued in order to put them on study restraints.
11. When the intent of single wrist restraint is only to hold the IV line and patient is not agitated or in delirium.
18 Years
ALL
No
Sponsors
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Griffin Hospital
OTHER
Principal Investigators
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haq nawaz, MD
Role: PRINCIPAL_INVESTIGATOR
Griffin Hospital
Locations
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Griffin Hospital
Derby, Connecticut, United States
Countries
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Other Identifiers
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2002-25
Identifier Type: -
Identifier Source: org_study_id