Trial of Safety Nets In Hospitalized Patients - Full Text View

Sponsor:	Griffin Hospital
Information provided by:	Griffin Hospital
ClinicalTrials.gov Identifier:	NCT00409370

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 III

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

MedlinePlus related topics: Psychotic Disorders

U.S. FDA Resources

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:

age more than 18
hospitalized
acute confusion or agitation

Exclusion Criteria:

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.

Contacts and Locations

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

Study ID Numbers:	2002-25
Study First Received:	December 7, 2006
Last Updated:	December 7, 2006
ClinicalTrials.gov Identifier:	NCT00409370 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

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

Psychomotor Disorders
Neurologic Manifestations
Psychotic Disorders
Neurobehavioral Manifestations
Schizophrenia and Disorders with Psychotic Features
Delirium

ClinicalTrials.gov processed this record on November 27, 2009