Wireless Monitoring for Clinical Deterioration (i-PROTECT)

King Abdullah International Medical Research Center

Status: Not yet enrolling

Conditions: Inpatient Facililty Diagnoses

Treatments: Device: wireless monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06644599

ICT23R/006/08

Details and patient eligibility

About

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

Full 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.

Enrollment: 13,160 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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13,160 participants in 2 patient groups

Wireless monitoring

Active Comparator group

Description:

Wireless monitoring will be applied on patients who are at high risk, identified as having a National Early Warning Score (NEWS)-2 score of 5 or higher, patients with lower NEWS-2 scores if the clinical team has a clinical concern, patients with Critical Care Response Team (CCRT) activation regardless of NEWS-2 score and post-ICU discharges regardless of NEWS-2 score. The technology allows to have alarms for patients who meet preset thresholds for vital signs. These alarms are transmitted through a mobile device to the charge nurse of the related ward. The wireless system will be monitored 24/7 by a critical care nurse

Control

No Intervention group

Description:

Usual care with no wireless monitoring.