Trial of Safety Nets In Hospitalized Patients
This study has been completed.
Sponsor:
Griffin Hospital
Information provided by:
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT00409370
First received: December 7, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium Agitated Behavior Alcohol Withdrawl Acute Confusional State Acute Psychosis |
Device: SOMA safe enclosure |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients |
Resource links provided by NLM:
Further study details as provided by Griffin Hospital:
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
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | February 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00409370 History of Changes |
| Other Study ID Numbers: | 2002-25 |
| Study First Received: | December 7, 2006 |
| Last Updated: | December 7, 2006 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Confusion Delirium Mental Disorders Psychotic Disorders Psychomotor Agitation Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Schizophrenia and Disorders with Psychotic Features Dyskinesias Psychomotor Disorders |
ClinicalTrials.gov processed this record on May 21, 2013