Trial of Safety Nets In Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00409370
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
Information provided by:
Griffin Hospital

December 7, 2006
December 8, 2006
December 8, 2006
April 2003
Not Provided
  • Perception of the Nurse
  • perception of physician
  • perception of family member
  • agitated behavior scale
  • alcohol withdrawal assessment scale
Same as current
No Changes Posted
  • total duration of restraint use
  • length of hospital stay
  • total sedative medication dose used
Same as current
Not Provided
Not Provided
Trial of Safety Nets In Hospitalized Patients
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Delirium
  • Agitated Behavior
  • Alcohol Withdrawl
  • Acute Confusional State
  • Acute Psychosis
Device: SOMA safe enclosure
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2005
Not Provided

Inclusion Criteria:

  1. age more than 18
  2. hospitalized
  3. acute confusion or agitation

Exclusion Criteria:

  1. Patients who require acute respiratory or cardiac support such as patients requiring ventilator support or patients in cardiac or septic shock
  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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Griffin Hospital
Not Provided
Principal Investigator: haq nawaz, MD Griffin Hospital
Griffin Hospital
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP