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OpenTrials
Completed

NCT Number: NCT00409370

Trial of Safety Nets In 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SOMA safe enclosure

Device

Primary outcomes

  1. Perception of the Nurse

  2. perception of physician

  3. perception of family member

  4. agitated behavior scale

  5. alcohol withdrawal assessment scale

Secondary outcomes

  1. total duration of restraint use

  2. length of hospital stay

  3. total sedative medication dose used

Sponsors and collaborators

Lead sponsor

Griffin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Dec 8, 2006
Registry last updated
Dec 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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