Wireless Monitoring for Clinical Deterioration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: wireless monitoring.
- Who it may be relevant to
- Registry conditions: Inpatient Facililty Diagnoses. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial
Overview
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.
Interventions
- 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).
Primary outcome measures
- Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation [Time frame: 30 days]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Saudi Arabia · 1 center
- King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arab — Riyadh
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. PMID 23376502
- 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
- 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
- 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/s1361 PMID 28560683
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06644599 · ICT23R/006/08