Wireless Monitoring of Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial (i-PROTECT Trial): Clinical Study Protocol and Statistical Analysis Plan
- 1King Abdulaziz Medical City Ministry of National Guard Health Affairs, Riyadh, Kingdom of Saudi Arabia.College of Medicin, King Saud Bin Abdulaziz University f
Abstract
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. Clinicaltrial.gov NCT06644599 Strengths and limitations of this study The pragmatic design reflects routine clinical practice and therefore enhances external validity. The study has a large sample size, standardized electronic data collection, and centralized monitoring, minimizing selection bias and missing outcome data. The main limitation is the inability to blind healthcare providers and secular changes in clinical practice over time.
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BibTeX
@misc{arabi2026wireless,
title = {{Wireless Monitoring of Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial (i-PROTECT Trial): Clinical Study Protocol and Statistical Analysis Plan}},
author = {Y. Arabi and A. Alsaawi and T. Al Debasi and A. Al Khathaami and K. Almajed and H. M. Al-Dorzi and N. Tashkandi and R. Al Hazme and A. Matroud and A. Caswell and H. I. Ardah and K. K. Groenbaek and N. Al Ayadhi and A. Alatassi and S. S. Aldekhyl and S. Y. Alqahtani and S. Al-Qahtani and A. Al Rashid and Z. Yousef and A. Alhadab and R. Alotaibi and W. Molala and M. S. K. Alrashidi and M. M. Alotaibi and G. H. Alenazi and R. Alotaibi and B. Yadav and M. Sadat and K. Alshurman and A. Al Enezi and W. Al Rassamah and A. S. Al Shuail and A. Abdulaal and A. Al-Dawood},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.30.26364373},
url = {https://www.medrxiv.org/content/10.64898/2026.09.30.26364373v1},
note = {Public domain},
}
RIS
TY - UNPB
TI - Wireless Monitoring of Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial (i-PROTECT Trial): Clinical Study Protocol and Statistical Analysis Plan
AU - Y. Arabi
AU - A. Alsaawi
AU - T. Al Debasi
AU - A. Al Khathaami
AU - K. Almajed
AU - H. M. Al-Dorzi
AU - N. Tashkandi
AU - R. Al Hazme
AU - A. Matroud
AU - A. Caswell
AU - H. I. Ardah
AU - K. K. Groenbaek
AU - N. Al Ayadhi
AU - A. Alatassi
AU - S. S. Aldekhyl
AU - S. Y. Alqahtani
AU - S. Al-Qahtani
AU - A. Al Rashid
AU - Z. Yousef
AU - A. Alhadab
AU - R. Alotaibi
AU - W. Molala
AU - M. S. K. Alrashidi
AU - M. M. Alotaibi
AU - G. H. Alenazi
AU - R. Alotaibi
AU - B. Yadav
AU - M. Sadat
AU - K. Alshurman
AU - A. Al Enezi
AU - W. Al Rassamah
AU - A. S. Al Shuail
AU - A. Abdulaal
AU - A. Al-Dawood
PY - 2026
DA - 2026/09/30
PB - medRxiv
DO - 10.64898/2026.09.30.26364373
UR - https://www.medrxiv.org/content/10.64898/2026.09.30.26364373v1
AB - 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. Clinicaltrial.gov NCT06644599 Strengths and limitations of this study The pragmatic design reflects routine clinical practice and therefore enhances external validity. The study has a large sample size, standardized electronic data collection, and centralized monitoring, minimizing selection bias and missing outcome data. The main limitation is the inability to blind healthcare providers and secular changes in clinical practice over time.
ER -