Status:
COMPLETED
Trial of Safety Nets In Hospitalized Patients
Lead Sponsor:
Griffin Hospital
Conditions:
Delirium
Agitated Behavior
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfac...
Eligibility Criteria
Inclusion
- age more than 18
- hospitalized
- acute confusion or agitation
Exclusion
- Patients who require acute respiratory or cardiac support such as patients requiring ventilator support or patients in cardiac or septic shock
- Patients who have a documented history of claustrophobia
- 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
- 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.
- Acutely ill patients requiring intravenous vasopressors, intubation or ventilatory support
- Other conditions deemed terminal within 24 hours as determined by the patient's attending physician
- Patients who stay less than 24 hours in the hospital
- If patient is already on restrains for more than 48 hours preceding enrollment.
- If two or more limbs are already on restraint to protect IV lines.
- 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.
- When the intent of single wrist restraint is only to hold the IV line and patient is not agitated or in delirium.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00409370
Start Date
April 1 2003
End Date
February 1 2005
Last Update
December 8 2006
Active Locations (1)
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1
Griffin Hospital
Derby, Connecticut, United States, 06418