Wireless Monitoring for Clinical Deterioration

NCT06644599 | Recruiting FDA Device

• 1 other identifier: ICT23R/006/08
• Study Type: interventional
• Target: 13,160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inpatient Facililty Diagnoses

Keywords

inpatients; wireless monitoring; mortality; cardiopulmonary failure

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation

  After hospital admission within 30 days

  30 days

Secondary Outcomes (7)

• Cardiac arrest

  30 days

• Requirement of vasopressors

  within 30 days of hospital admission

• Requirement of intubation

  30 days

• Hospital length of stay

  90 days

• Transfer to ICU

  30 days

Study Arms (2)

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.

Interventions

wireless monitoring DEVICE

The monitoring wireless system will continuously monitor the heart rate, oxygen saturation (SpO2), respiratory rate, and blood pressure and in selected patients electrocardiography (ECG).

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

Related Publications (17)

• 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.

  PMID: 23376502 RESULT

• Buist 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.

  PMID: 15294398 RESULT

• Al-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.

  PMID: 23263618 RESULT

• Arabi 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.

  PMID: 28560683 RESULT

• Hogan 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.

  PMID: 22927487 RESULT

• Armitage 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.

  PMID: 17673769 RESULT

• Smith 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.

  PMID: 20598425 RESULT

• Weenk 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.

  PMID: 28679490 RESULT

• Breteler 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.

  PMID: 29487076 RESULT

• Breteler 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.

  PMID: 31743149 RESULT

• Bellomo 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.

  PMID: 22809908 RESULT

• Subbe 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.

  PMID: 28288655 RESULT

• Taenzer 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.

  PMID: 20098128 RESULT

• Mdege 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.

  PMID: 21411284 RESULT

• Porsdam 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.

  PMID: 28336803 RESULT

• Gonzales R, Anderer T, McCulloch CE, Maselli JH, Bloom FJ Jr, Graf TR, Stahl M, Yefko M, Molecavage J, Metlay JP. A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis. JAMA Intern Med. 2013 Feb 25;173(4):267-73. doi: 10.1001/jamainternmed.2013.1589.

  PMID: 23319069 RESULT

• van Wyk JT, van Wijk MA, Sturkenboom MC, Mosseveld M, Moorman PW, van der Lei J. Electronic alerts versus on-demand decision support to improve dyslipidemia treatment: a cluster randomized controlled trial. Circulation. 2008 Jan 22;117(3):371-8. doi: 10.1161/CIRCULATIONAHA.107.697201. Epub 2008 Jan 2.

  PMID: 18172036 RESULT

Central Study Contacts

Yaseen M Arabi, MD

CONTACT

018011111; arabi@mngha.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will be maintained with a research coordinator who is not involved in this trial, and the ward allocation will remain concealed from the research and clinical teams throughout the study and will be revealed for a given sequence only 1 month before the implementation of the intervention to allow training.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman intensive care unit

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)