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Trial of Safety Nets In Hospitalized Patients

Sponsor
Griffin Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00409370
Collaborator
(none)
60
Enrollment
1
Location
22.1
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SOMA safe enclosure
 Phase 3

Study Design

Study Type:
Interventional
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
Study Start Date :
Apr 1, 2003
Study Completion Date :
Feb 1, 2005

Outcome Measures

Primary Outcome Measures

  1. Perception of the Nurse []

  2. perception of physician []

  3. perception of family member []

  4. agitated behavior scale []

  5. alcohol withdrawal assessment scale []

Secondary Outcome Measures

  1. total duration of restraint use []

  2. length of hospital stay []

  3. total sedative medication dose used []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Griffin Hospital Derby Connecticut United States 06418

Sponsors and Collaborators

  • Griffin Hospital

Investigators

  • Principal Investigator: haq nawaz, MD, Griffin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00409370
Other Study ID Numbers:
  • 2002-25
First Posted:
Dec 8, 2006
Last Update Posted:
Dec 8, 2006
Last Verified:
Dec 1, 2006
Additional relevant MeSH terms:
Delirium
Psychomotor Agitation
Confusion

Study Results

No Results Posted as of Dec 8, 2006