Using Technical Filtering and Clinical Criteria to Reduce Vital Sign Alarms Using Continuous Monitoring in the Ward

NCT05171322 | Completed DMC FDA Device

• 1 other identifier: AWARD (Alert WARD)
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the extent of vital sign threshold alarm reduction in relation to several simple multilevel minimum duration criteria and artefact removal. We hypothesize that the amount off false alarms will be decreased using different filters.

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (1)

• Calculated number of any vital sign threshold alarms/patient/24 hours (bradypnea, tachypnea, desaturation, sinus tachycardia, bradycardia, hypotension and hypertension).

  24 hours

Secondary Outcomes (7)

• Number of bradypnea threshold alarms/patient/24 hours.

  24 hours

• Number of tachypnea threshold alarms/patient/24 hours.

  24 hours

• Number of desaturation threshold alarms/patient/24 hours.

  24 hours

• Number of sinus tachycardia threshold alarms/patient/24 hours.

  24 hours

• Number of bradycardia threshold alarms/patient/24 hours.

  24 hours

Other Outcomes (1)

• Number of vital sign threshold alarms/patient for efficiency levels at 0%, 25%, 50%, 75% and 100%, firstly within the first hour, afterwards following the first 3 hours, 6 hours, 12 hours and 24 hours.

  1 hour, 3 hours, 6 hours, 12 hours and 24 hours

Study Arms (1)

All patients

All patients included were set up with the WARD monitoring devices.

Device: WARD

Interventions

WARD DEVICE

The following monitoring devices are included in the WARD monitoring system (as intervention): Isansys Life Touch patch: Measures heart rate (HR), respiratory rate (RR) and electrocardiogram (ECG) Wearable, wireless Pulse Oximeter (Model 3150 WristOx from Nonin): Measures peripheral oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) Blood pressure monitor (Meditech BlueBP-05): Measures BP every 30 minutes during daytime and every 60 minutes during the night All included patients are set up with the monitoring devices after surgery when they are back at their ward (with a maximum of 24 hours postoperative). Afterwards they wear the devices for up to 5 days. All measurements are sent through bluetooth to a tablet serving as a gateway which in turn sends data to a central server where the algorithmic processing ensures.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are included from prospective WARD studies. The WARD surgery project (NCT03491137), the WARD COPD project (NCT03660501), the WARD CGM (NCT04473001), the WARD CODP pilot project (NCT03467815) and the WARD VASC project (NCT04628858).

You may qualify if:

• WARD COPD project (NCT03660501):
• ≥18 years
• Patients admitted to emergency departments or pulmonary wards with AECOPD as admission diagnosis with suspected acute exacerbation of COPD
• Expected admittance longer than 24 hours
• Possibility of an investigator to include the patient within 24 hours from admission
• The WARD surgery project (NCT03491137):
• ≥ 60 years
• Elective major abdominal cancer surgery
• Estimated surgical duration ≥ 2 hours.
• WARD VASC project (NCT04628858):
• ≥ 18 years
• Patients with PAD which must undergo an open intraligamentary revascularization incl. a. femoralis TEA and intraligamentary bypass
• Patients admitted at the department of vascular surgery 3111 at Rigshospitalet regarding elective surgery
• Patients admitted the day before surgery and have an expected admitting time lasting more than 2 days (postoperatively)
• WARD CGM (NCT04473001):

You may not qualify if:

• WARD COPD project (NCT03660501):
• Patients who were not expected to cooperate to wear the monitoring equipment
• Unable to give informed consent
• Patients who were withheld active treatment
• Implanted cardioverter defibrillator or pacemaker
• Severe allergy for plaster/silicone
• WARD CODP pilot project (NCT03467815):
• ≥ 18 years
• The WARD surgery project (NCT03491137):
• Implanted cardioverter defibrillator or pacemaker
• Allergy to study devices
• Severe cognitive impairment assessed by MMSE
• Inability to cooperate wearing the wireless monitoring equipment
• WARD CODP pilot project (NCT03467815):
• Unable to give informed consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Department of Anesthesiology, Centre for Cancer and Organ Diseases

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stud.med

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 28, 2021
• Study Start: February 20, 2018
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

DK (1)