Trial of Safety Nets In Hospitalized Patients

Delirium Clinical Trial

Official title:

A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409370
• Other study ID #: 2002-25
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2006
• Last updated: December 7, 2006
• Start date: April 2003
• Est. completion date: February 2005

Study information

• Verified date: December 2006
• Source: Griffin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Confusional State
• Acute Psychosis
• Agitated Behavior
• Alcohol Withdrawl
• Confusion
• Delirium
• Psychomotor Agitation

Intervention

Device:
• SOMA safe enclosure

Locations

Country	Name	City	State
United States	Griffin Hospital	Derby	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Griffin Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of the Nurse
Primary	perception of physician
Primary	perception of family member
Primary	agitated behavior scale
Primary	alcohol withdrawal assessment scale
Secondary	total duration of restraint use
Secondary	length of hospital stay
Secondary	total sedative medication dose used