NCT06644599

Wireless Monitoring for Clinical Deterioration

Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13,160 (estimated)
• Sponsor: King Abdullah International Medical Research Center · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure.

Detailed description

The trial is designed as a stepped-wedge cluster RCT. Hospital wards (which constitute clusters in this design) will be randomized to have wireless monitoring, 7 wards at a time, with each 7 wards constituting a sequence. The study consists of 5 periods of two-month sequences followed by a one-month transition time with a phased introduction of the intervention. In the first period, all wards will have no wireless monitoring. After a baseline period of 2 (+1 washout) months, the intervention (monitoring system) will be implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences.

Conditions

• Inpatient Facililty Diagnoses

Interventions

Type	Name	Description
DEVICE	wireless monitoring	The monitoring wireless system will continuously monitor the heart rate, oxygen saturation (SpO2), respiratory rate, and blood pressure and in selected patients electrocardiography (ECG).

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-10-16
• Last updated: 2026-02-27

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated device study