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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00409370
Other study ID # 2002-25
Secondary ID
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
Est. primary completion date
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


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
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