Official Title: “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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary:

• Perception of the Nurse
• perception of physician
• perception of family member
• agitated behavior scale
• alcohol withdrawal assessment scale

Secondary:

• total duration of restraint use
• length of hospital stay
• total sedative medication dose used

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.

Lead Sponsor: Griffin Hospital

Griffin Hospital

Derby Connecticut 06418 United States

Overall Clinical Trial Officials and Contacts

haq nawaz, MD Principal Investigator Griffin Hospital  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00409370

Study ID Number: 2002-25

ClinicalTrials.gov Identifier: NCT00409370

Health Authority: United States: Institutional Review Board