Wireless Monitoring for Clinical Deterioration (i-PROTECT)

February 25, 2026 updated by: Dr Yaseen Arabi, King Abdullah International Medical Research Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

13160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia
        • Recruiting
        • King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
        • Contact:
          • Yaseen M Arabi, MD, FCCP, FCCM, ATSF
          • Phone Number: 18855 +966 (11) 801-1111
          • Email: arabi@mngha.med.sa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Wireless monitoring
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
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).
No Intervention: Control
Usual care with no wireless monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
Time Frame: 30 days
After hospital admission within 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah International Medical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICT23R/006/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared at the discretion of the Principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inpatient Facililty Diagnoses

Clinical Trials on wireless monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe