Wireless monitoring to detect clinical deterioration in hospital wards
Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial
NA · King Abdullah International Medical Research Center · NCT06644599
This tests whether wireless bedside sensors for inpatients aged 14 and older can reduce deaths and cardiopulmonary failure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 13160 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | King Abdullah International Medical Research Center (other) |
| Locations | 1 site (Riyadh, Riyadh Region) |
| Trial ID | NCT06644599 on ClinicalTrials.gov |
What this trial studies
This is a stepped-wedge cluster randomized trial introducing a wireless monitoring system across adult inpatient wards at a single hospital. Wards are randomized in sequences of seven and the intervention is rolled out in phases with a baseline period and one-month transition windows, with a new sequence implementing monitoring every three months until all wards have the intervention. All patients aged 14 or older admitted to eligible general wards will receive either standard care or wireless monitoring depending on the ward phase, while cardiology, pediatric, obstetric, ICU, emergency, operating room and outpatient areas are excluded. Outcomes include inpatient mortality and cardiopulmonary failure events captured from clinical records and the monitoring system.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 years or older admitted to eligible general adult inpatient wards at the hospital.
Not a fit: Patients in excluded wards (cardiology, pediatric, obstetric, ICUs, emergency departments, operating rooms, outpatient clinics, day procedure areas, and hemodialysis units) or those with a Do-Not-Resuscitate/no full life support status on arrival are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could reduce inpatient deaths and serious heart or breathing events by enabling earlier detection and response.
How similar studies have performed: Previous studies of continuous wireless or wearable monitoring on hospital wards have shown earlier detection of deterioration and reduced ICU transfers in some settings, but results for lowering mortality have been mixed and not consistently demonstrated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Ward level Inpatient wards, defined as wards used to manage adult inpatients. Patient level 1. Aged 14 years or older 2. Checked in as inpatient status to one of the study wards Exclusion Criteria: Ward level 1. Cardiology, pediatric, obstetric wards 2. ICUs and emergency departments 3. Operating rooms 4. Outpatient clinics 5. Daycare wards, endoscopy, outpatient procedure areas, hemodialysis units Patient level No commitment for full life support at the time of arrival to the study ward (designated as Do-Not-Resuscitate status)
Where this trial is running
Riyadh, Riyadh Region
- King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia — Riyadh, Riyadh Region, Saudi Arabia (RECRUITING)
Study contacts
- Study coordinator: Yaseen M Arabi, MD
- Email: arabi@mngha.med.sa
- Phone: 018011111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inpatient Facililty Diagnoses, inpatients, wireless monitoring, mortality, cardiopulmonary failure