Trial of Safety Nets In Hospitalized Patients

This study has been completed.
Sponsor:
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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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:
Psychomotor Agitation
Confusion
Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014