Inpatient Facililty Diagnosesi-PROTECTNCT06644599
Wireless Monitoring for Clinical Deterioration
A study testing wireless monitoring in people with Inpatient Facililty Diagnoses, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Inpatient Facililty Diagnoses
- What is being tested?
- wireless monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,160 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ward level Inpatient wards, defined as wards used to manage adult inpatients.
- Patient level
- Aged 14 years or older
- Checked in as inpatient status to one of the study wards
Who cannot join
- Ward level
- Cardiology, pediatric, obstetric wards
- ICUs and emergency departments
- Operating rooms
- Outpatient clinics
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia
Riyadh, Riyadh Region
Yaseen M Arabi, MD, FCCP, FCCM, ATSF, +966 (11) 801-1111 ext. 18855, arabi@mngha.med.sa
About this study
Official title: 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.
Read the 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.
- Conditions
- Inpatient Facililty Diagnoses
- Being tested
- wireless monitoring
- Keywords
- inpatients, wireless monitoring, mortality, cardiopulmonary failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wireless monitoringDevice
The monitoring wireless system will continuously monitor the heart rate, oxygen saturation (SpO2), respiratory rate, and blood pressure and in selected patients electrocardiography (ECG).
| Study group | Role | What they receive |
|---|---|---|
| Wireless monitoring | Active comparator | 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 | Usual care with no wireless monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
After hospital admission within 30 days
Measured: 30 days
Secondary outcomes (7)
Cardiac arrest
cardiac arrest within 30 days of hospital admission
Measured: 30 days
Requirement of vasopressors
use of vasopressors/inotropic support
Measured: within 30 days of hospital admission
Requirement of intubation
need for mechanical ventilation within 30 days of hospital admission
Measured: 30 days
Hospital length of stay
censored at 90 days
Measured: 90 days
Transfer to ICU
ICU admission within 30 days of hospital admission
Measured: 30 days
ICU- free days
in the first 30 days of hospital admission
Measured: 30 days
CCRT activation
Critical care response team activation within 30 days of hospital admission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Inpatient Facililty DiagnosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 13,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yaseen Arabi, King Saud Bin Abdulaziz University for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644599
- Sponsor's protocol ID
- ICT23R/006/08
- Acronym
- i-PROTECT
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared at the discretion of the Principal investigator
Publications
Jones D, Mitchell I, Hillman K, Story D. Defining clinical deterioration. Resuscitation. 2013 Aug;84(8):1029-34. doi: 10.1016/j.resuscitation.2013.01.013. Epub 2013 Jan 31.
PubMed 23376502Buist M, Bernard S, Nguyen TV, Moore G, Anderson J. Association between clinically abnormal observations and subsequent in-hospital mortality: a prospective study. Resuscitation. 2004 Aug;62(2):137-41. doi: 10.1016/j.resuscitation.2004.03.005.
PubMed 15294398Al-Qahtani S, Al-Dorzi HM, Tamim HM, Hussain S, Fong L, Taher S, Al-Knawy BA, Arabi Y. Impact of an intensivist-led multidisciplinary extended rapid response team on hospital-wide cardiopulmonary arrests and mortality. Crit Care Med. 2013 Feb;41(2):506-17. doi: 10.1097/CCM.0b013e318271440b.
PubMed 23263618Arabi YM, Al-Dorzi HM, Alamry A, Hijazi R, Alsolamy S, Al Salamah M, Tamim HM, Al-Qahtani S, Al-Dawood A, Marini AM, Al Ehnidi FH, Mundekkadan S, Matroud A, Mohamed MS, Taher S. The impact of a multifaceted intervention including sepsis electronic alert system and sepsis response team on the outcomes of patients with sepsis and septic shock. Ann Intensive Care. 2017 Dec;7(1):57. doi: 10.1186/s13613-017-0280-7. Epub 2017 May 30.
PubMed 28560683Hogan H, Healey F, Neale G, Thomson R, Vincent C, Black N. Preventable deaths due to problems in care in English acute hospitals: a retrospective case record review study. BMJ Qual Saf. 2012 Sep;21(9):737-45. doi: 10.1136/bmjqs-2011-001159.
PubMed 22927487Armitage M, Eddleston J, Stokes T; Guideline Development Group at the NICE. Recognising and responding to acute illness in adults in hospital: summary of NICE guidance. BMJ. 2007 Aug 4;335(7613):258-9. doi: 10.1136/bmj.39272.679688.47. No abstract available.
PubMed 17673769Smith GB. In-hospital cardiac arrest: is it time for an in-hospital 'chain of prevention'? Resuscitation. 2010 Sep;81(9):1209-11. doi: 10.1016/j.resuscitation.2010.04.017. Epub 2010 Jul 2.
PubMed 20598425Weenk M, van Goor H, Frietman B, Engelen LJ, van Laarhoven CJ, Smit J, Bredie SJ, van de Belt TH. Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study. JMIR Mhealth Uhealth. 2017 Jul 5;5(7):e91. doi: 10.2196/mhealth.7208.
PubMed 28679490Breteler MJM MSc, Huizinga E, van Loon K, Leenen LPH, Dohmen DAJ, Kalkman CJ, Blokhuis TJ. Reliability of wireless monitoring using a wearable patch sensor in high-risk surgical patients at a step-down unit in the Netherlands: a clinical validation study. BMJ Open. 2018 Feb 27;8(2):e020162. doi: 10.1136/bmjopen-2017-020162.
PubMed 29487076Breteler MJM, KleinJan EJ, Dohmen DAJ, Leenen LPH, van Hillegersberg R, Ruurda JP, van Loon K, Blokhuis TJ, Kalkman CJ. Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study. Anesthesiology. 2020 Mar;132(3):424-439. doi: 10.1097/ALN.0000000000003029.
PubMed 31743149Bellomo R, Ackerman M, Bailey M, Beale R, Clancy G, Danesh V, Hvarfner A, Jimenez E, Konrad D, Lecardo M, Pattee KS, Ritchie J, Sherman K, Tangkau P; Vital Signs to Identify, Target, and Assess Level of Care Study (VITAL Care Study) Investigators. A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards. Crit Care Med. 2012 Aug;40(8):2349-61. doi: 10.1097/CCM.0b013e318255d9a0.
PubMed 22809908Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.
PubMed 28288655Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b.
PubMed 20098128Mdege ND, Man MS, Taylor Nee Brown CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011 Sep;64(9):936-48. doi: 10.1016/j.jclinepi.2010.12.003. Epub 2011 Mar 16.
PubMed 21411284Porsdam Mann S, Savulescu J, Sahakian BJ. Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue. Philos Trans A Math Phys Eng Sci. 2016 Dec 28;374(2083):20160130. doi: 10.1098/rsta.2016.0130.
PubMed 28336803
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial
- ClinicalTrials.gov ID
- NCT06644599
- Acronym / sponsor ID
- i-PROTECT / ICT23R/006/08
- Conditions
- Inpatient Facililty Diagnoses
- Keywords
- inpatients, wireless monitoring, mortality, cardiopulmonary failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13,160 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wireless monitoring | Active comparator | –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 | –Usual care with no wireless monitoring. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Ward level Inpatient wards, defined as wards used to manage adult inpatients.
- Patient level
- Aged 14 years or older
- Checked in as inpatient status to one of the study wards
Key exclusion criteria (7 listed)
- Ward level
- Cardiology, pediatric, obstetric wards
- ICUs and emergency departments
- Operating rooms
- Outpatient clinics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wireless monitoringThe monitoring wireless system will continuously monitor the heart rate, oxygen saturation (SpO2), respiratory rate, and blood pressure and in selected patients electrocardiography (ECG). | Device | – |
Primary outcome
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
7 secondary outcomes
Cardiac arrest
Time frame: 30 days
Requirement of vasopressors
Time frame: within 30 days of hospital admission
Requirement of intubation
Time frame: 30 days
Hospital length of stay
Time frame: 90 days
Transfer to ICU
Time frame: 30 days
ICU- free days
Time frame: 30 days
CCRT activation
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 23376502Jones D, Mitchell I, Hillman K, Story D. Defining clinical deterioration. Resuscitation. 2013 Aug;84(8):1029-34. doi: 10.1016/j.resuscitation.2013.01.013. Epub 2013 Jan 31.
- Results publication: PubMed 15294398Buist M, Bernard S, Nguyen TV, Moore G, Anderson J. Association between clinically abnormal observations and subsequent in-hospital mortality: a prospective study. Resuscitation. 2004 Aug;62(2):137-41. doi: 10.1016/j.resuscitation.2004.03.005.
- Results publication: PubMed 23263618Al-Qahtani S, Al-Dorzi HM, Tamim HM, Hussain S, Fong L, Taher S, Al-Knawy BA, Arabi Y. Impact of an intensivist-led multidisciplinary extended rapid response team on hospital-wide cardiopulmonary arrests and mortality. Crit Care Med. 2013 Feb;41(2):506-17. doi: 10.1097/CCM.0b013e318271440b.
- Results publication: PubMed 28560683Arabi YM, Al-Dorzi HM, Alamry A, Hijazi R, Alsolamy S, Al Salamah M, Tamim HM, Al-Qahtani S, Al-Dawood A, Marini AM, Al Ehnidi FH, Mundekkadan S, Matroud A, Mohamed MS, Taher S. The impact of a multifaceted intervention including sepsis electronic alert system and sepsis response team on the outcomes of patients with sepsis and septic shock. Ann Intensive Care. 2017 Dec;7(1):57. doi: 10.1186/s13613-017-0280-7. Epub 2017 May 30.
- Results publication: PubMed 22927487Hogan H, Healey F, Neale G, Thomson R, Vincent C, Black N. Preventable deaths due to problems in care in English acute hospitals: a retrospective case record review study. BMJ Qual Saf. 2012 Sep;21(9):737-45. doi: 10.1136/bmjqs-2011-001159.
- Results publication: PubMed 17673769Armitage M, Eddleston J, Stokes T; Guideline Development Group at the NICE. Recognising and responding to acute illness in adults in hospital: summary of NICE guidance. BMJ. 2007 Aug 4;335(7613):258-9. doi: 10.1136/bmj.39272.679688.47. No abstract available.
- Results publication: PubMed 20598425Smith GB. In-hospital cardiac arrest: is it time for an in-hospital 'chain of prevention'? Resuscitation. 2010 Sep;81(9):1209-11. doi: 10.1016/j.resuscitation.2010.04.017. Epub 2010 Jul 2.
- Results publication: PubMed 28679490Weenk M, van Goor H, Frietman B, Engelen LJ, van Laarhoven CJ, Smit J, Bredie SJ, van de Belt TH. Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study. JMIR Mhealth Uhealth. 2017 Jul 5;5(7):e91. doi: 10.2196/mhealth.7208.
- Results publication: PubMed 29487076Breteler MJM MSc, Huizinga E, van Loon K, Leenen LPH, Dohmen DAJ, Kalkman CJ, Blokhuis TJ. Reliability of wireless monitoring using a wearable patch sensor in high-risk surgical patients at a step-down unit in the Netherlands: a clinical validation study. BMJ Open. 2018 Feb 27;8(2):e020162. doi: 10.1136/bmjopen-2017-020162.
- Results publication: PubMed 31743149Breteler MJM, KleinJan EJ, Dohmen DAJ, Leenen LPH, van Hillegersberg R, Ruurda JP, van Loon K, Blokhuis TJ, Kalkman CJ. Vital Signs Monitoring with Wearable Sensors in High-risk Surgical Patients: A Clinical Validation Study. Anesthesiology. 2020 Mar;132(3):424-439. doi: 10.1097/ALN.0000000000003029.
- Results publication: PubMed 22809908Bellomo R, Ackerman M, Bailey M, Beale R, Clancy G, Danesh V, Hvarfner A, Jimenez E, Konrad D, Lecardo M, Pattee KS, Ritchie J, Sherman K, Tangkau P; Vital Signs to Identify, Target, and Assess Level of Care Study (VITAL Care Study) Investigators. A controlled trial of electronic automated advisory vital signs monitoring in general hospital wards. Crit Care Med. 2012 Aug;40(8):2349-61. doi: 10.1097/CCM.0b013e318255d9a0.
- Results publication: PubMed 28288655Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.
- Individual participant dataSharing planned: Yes. Data will be shared at the discretion of the Principal investigator
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wireless monitoring in people with Inpatient Facililty Diagnoses, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaseen M Arabi, MD (018011111 ext. 18899, arabi@mngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06644599, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.