Trial of Safety Nets In Hospitalized Patients

NCT00409370 | Completed Phase 3

• 1 other identifier: 2002-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Agitated Behavior; Alcohol Withdrawl; Acute Confusional State; Acute Psychosis

Outcome Measures

Primary Outcomes (5)

• Perception of the Nurse

• perception of physician

• perception of family member

• agitated behavior scale

• alcohol withdrawal assessment scale

Secondary Outcomes (3)

• total duration of restraint use

• length of hospital stay

• total sedative medication dose used

Interventions

SOMA safe enclosure DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18
• hospitalized
• acute confusion or agitation

You may not qualify if:

• Patients who require acute respiratory or cardiac support such as patients requiring ventilator support or patients in cardiac or septic shock
• Patients who have a documented history of claustrophobia
• 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
• 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.
• Acutely ill patients requiring intravenous vasopressors, intubation or ventilatory support
• Other conditions deemed terminal within 24 hours as determined by the patient's attending physician
• Patients who stay less than 24 hours in the hospital
• If patient is already on restrains for more than 48 hours preceding enrollment.
• If two or more limbs are already on restraint to protect IV lines.
• 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.
• When the intent of single wrist restraint is only to hold the IV line and patient is not agitated or in delirium.

Sponsors & Collaborators

• Griffin Hospital: lead

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Delirium; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• haq nawaz, MD

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 8, 2006
• Study Start: April 1, 2003
• Study Completion: February 1, 2005
• Last Updated: December 8, 2006

Record last verified: 2006-12

Locations

US (1)