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Trial of Safety Nets In Hospitalized Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409370
First Posted: December 8, 2006
Last Update Posted: December 8, 2006
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.
Information provided by:
Griffin Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409370


Locations
United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
Investigators
Principal Investigator: haq nawaz, MD Griffin Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00409370     History of Changes
Other Study ID Numbers: 2002-25
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: December 8, 2006
Last Verified: December 2006

Additional relevant MeSH terms:
Delirium
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Psychomotor Disorders