Trial of Safety Nets In Hospitalized Patients
Information source: Griffin Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium; Agitated Behavior; Alcohol Withdrawl; Acute Confusional State; Acute Psychosis
Intervention: SOMA safe enclosure (Device)
Phase: Phase 3
Sponsored by: Griffin Hospital
Official(s) and/or principal investigator(s):
haq nawaz, MD, Principal Investigator, Affiliation: Griffin Hospital
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.
Official title: A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
Study design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Perception of the Nurse
perception of physician
perception of family member
agitated behavior scale
alcohol withdrawal assessment scale
total duration of restraint use
length of hospital stay
total sedative medication dose used
Minimum age: 18 Years.
Maximum age: N/A.
1. age more than 18
3. acute confusion or agitation
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
6. Other conditions deemed terminal within 24 hours as determined by the patient's
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.
Locations and Contacts
Griffin Hospital, Derby, Connecticut 06418, United States
Starting date: April 2003
Ending date: February 2005
Last updated: December 7, 2006