ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Delirium of Mixed Origin Clinical Trial

Official title:

ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03901976
• Other study ID #: YGB-PH-CS-BD-2018-02-18
• Status: Terminated
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2020
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

Description:

In ZeroFall we intend to observe patients on risk of fall with two different devices during their hospital stay: The information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at Bangor. Both are compatible with an existing monitoring system by Philips Healthcare and CE marked.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients with risk of fall more than 24 hours on the ward

Exclusion Criteria:

Patients with predominantly palliative needs

Related Conditions & MeSH terms

• Delirium
• Delirium of Mixed Origin

Intervention

Device:
• bed exit detection
bed exit detection to avoid patients fall

Locations

Country	Name	City	State
United Kingdom	Ysbyty Gwynedd	Bangor	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of true bed exit detections vs number of false bed exit detections	A reference device and two observers will classify if a bed exit was true	12-15 months