Wireless Monitoring of Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial (i-PROTECT Trial): Clinical Study Protocol and Statistical Analysis Plan

Introduction: Clinical deterioration in patients admitted to hospital wards is a major cause of preventable morbidity and mortality and is frequently preceded by abnormalities in vital signs that occur hours before serious adverse events occur. Early identification of patients at risk provides an opportunity for timely intervention before irreversible organ dysfunction develops. The objective of this trial is to evaluate whether implementing a wireless patient monitoring system reduces mortality and cardiopulmonary failure in patients admitted to hospital wards. Methods and analysis: The i-PROTECT trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 28 wards, constituting clusters in this design) are randomized to have wireless monitoring for selected high-risk patients, 7 wards at a time, with every 7 wards constituting a sequence. In the first period, all wards will have no wireless monitoring. After a baseline period of 2 (+1 transition) months, the intervention is implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences. The control group will receive usual care with standard intermittent monitoring and no wireless monitoring. The calculated sample size is 13160 patients. The primary endpoint is cardiopulmonary failure; a composite endpoint of 30-day in-hospital mortality, cardiac arrest, and need for vasopressor or intubation. The trial started on Feb 1, 2026, and is expected to complete patient follow-up by the end of May 2027. Ethics and dissemination: The trial was approved by the Institutional review board (IRB) of Ministry of National Guard Health Affairs (IRB/2623/23). The results will be presented at relevant national and international critical care conferences and published in international peer-reviewed journals.