- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409370
Trial of Safety Nets In Hospitalized Patients
December 7, 2006 updated by: Griffin Hospital
A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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Derby, Connecticut, United States, 06418
- Griffin Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Perception of the Nurse
|
perception of physician
|
perception of family member
|
agitated behavior scale
|
alcohol withdrawal assessment scale
|
Secondary Outcome Measures
Outcome Measure |
---|
length of hospital stay
|
total duration of restraint use
|
total sedative medication dose used
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: haq nawaz, MD, Griffin Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion
February 1, 2005
Study Registration Dates
First Submitted
December 7, 2006
First Submitted That Met QC Criteria
December 7, 2006
First Posted (Estimate)
December 8, 2006
Study Record Updates
Last Update Posted (Estimate)
December 8, 2006
Last Update Submitted That Met QC Criteria
December 7, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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