DeliriumPhase 3NCT00409370
Trial of Safety Nets In Hospitalized Patients
A Phase 3 study testing SOMA safe enclosure in people with Delirium and Agitated Behavior, run by Griffin Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Agitated Behavior, Alcohol Withdrawl
- What is being tested?
- SOMA safe enclosure
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Feb 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18
- hospitalized
- acute confusion or agitation
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
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.
- Being tested
- SOMA safe enclosure
- Medical subject headings
- Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOMA safe enclosureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startApr 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Investigators
- haq nawaz, MD, Principal investigator, Griffin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409370
- Sponsor's protocol ID
- 2002-25
- Status last verified
- Dec 2006
- First submitted
- 7 Dec 2006
- Last updated
- 8 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Compare The Use Of Safety Net Enclosures With Standard Restraints in Agitated Hospitalized Patients
- ClinicalTrials.gov ID
- NCT00409370
- Acronym / sponsor ID
- 2002-25
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Feb 2005
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age more than 18
- hospitalized
- acute confusion or agitation
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOMA safe enclosure | Device | – |
Primary outcome
Perception of the Nurse
perception of physician
perception of family member
agitated behavior scale
alcohol withdrawal assessment scale
3 secondary outcomes
total duration of restraint use
length of hospital stay
total sedative medication dose used
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
haq nawaz, MD principal investigator
Griffin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOMA safe enclosure in people with Delirium and Agitated Behavior, run by Griffin Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of the Nurse. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2006.