Back to resultsTrial of Safety Nets In Hospitalized Patients
Primary Purpose
Delirium, Agitated Behavior, Alcohol Withdrawl
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SOMA safe enclosure
Sponsored by
About this trial
This is an interventional supportive care trial for Delirium
Eligibility Criteria
Inclusion Criteria:
- age more than 18
- hospitalized
- acute confusion or agitation
Exclusion Criteria:
- 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.
Sites / Locations
- Griffin Hospital
Outcomes
Primary Outcome Measures
Perception of the Nurse
perception of physician
perception of family member
agitated behavior scale
alcohol withdrawal assessment scale
Secondary Outcome Measures
total duration of restraint use
length of hospital stay
total sedative medication dose used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00409370
Brief Title
Trial of Safety Nets In Hospitalized Patients
Official Title
A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Griffin Hospital
4. Oversight
5. Study Description
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 satisfaction of MD, nurse, and relatives of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Agitated Behavior, Alcohol Withdrawl, Acute Confusional State, Acute Psychosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SOMA safe enclosure
Primary Outcome Measure Information:
Title
Perception of the Nurse
Title
perception of physician
Title
perception of family member
Title
agitated behavior scale
Title
alcohol withdrawal assessment scale
Secondary Outcome Measure Information:
Title
total duration of restraint use
Title
length of hospital stay
Title
total sedative medication dose used
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18
hospitalized
acute confusion or agitation
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
haq nawaz, MD
Organizational Affiliation
Griffin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Griffin Hospital
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
12. IPD Sharing Statement
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Trial of Safety Nets In Hospitalized Patients
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