Clinical trial NCT06644599: Wireless Monitoring for Clinical Deterioration
Official title: Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inpatient Facililty Diagnoses
Keywords: inpatients
wireless monitoring
mortality
cardiopulmonary failure
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 13160
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
measure: Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
timeFrame: 30 days
Secondary outcomes:
measure: Cardiac arrest
timeFrame: 30 days
measure: Requirement of vasopressors
timeFrame: within 30 days of hospital admission
measure: Requirement of intubation
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 90 days
measure: Transfer to ICU
timeFrame: 30 days
measure: ICU- free days
timeFrame: 30 days
measure: CCRT activation
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
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