Wireless Monitoring for Clinical Deterioration

Not Applicable

Not yet recruiting

• Conditions: Inpatient Facililty Diagnoses

• Registration Number: NCT06644599
• Lead Sponsor: King Abdullah International Medical Research Center

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Start: 2024-11
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation	30 days	After hospital admission within 30 days

Secondary Outcome Measures

Name	Time	Method
Cardiac arrest	30 days	cardiac arrest within 30 days of hospital admission
Requirement of vasopressors	within 30 days of hospital admission	use of vasopressors/inotropic support
Requirement of intubation	30 days	need for mechanical ventilation within 30 days of hospital admission
Hospital length of stay	90 days	censored at 90 days
Transfer to ICU	30 days	ICU admission within 30 days of hospital admission
ICU- free days	30 days	in the first 30 days of hospital admission
CCRT activation	30 days	Critical care response team activation within 30 days of hospital admission