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The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation | After hospital admission within 30 days | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac arrest | cardiac arrest within 30 days of hospital admission | 30 days |
| Requirement of vasopressors | use of vasopressors/inotropic support |
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Inclusion Criteria:
Ward level Inpatient wards, defined as wards used to manage adult inpatients.
Patient level
Exclusion Criteria:
Ward level
Patient level No commitment for full life support at the time of arrival to the study ward (designated as Do-Not-Resuscitate status)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaseen M Arabi, MD | Contact | 018011111 | 18899 | arabi@mngha.med.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia | Recruiting | Riyadh | Riyadh Region | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23376502 | Result | 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. | |
| 15294398 | 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. |
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Data will be shared at the discretion of the Principal investigator
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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.
| within 30 days of hospital admission |
| Requirement of intubation | need for mechanical ventilation within 30 days of hospital admission | 30 days |
| Hospital length of stay | censored at 90 days | 90 days |
| Transfer to ICU | ICU admission within 30 days of hospital admission | 30 days |
| ICU- free days | in the first 30 days of hospital admission | 30 days |
| CCRT activation | Critical care response team activation within 30 days of hospital admission | 30 days |
| 23263618 | 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. |
| 28560683 | 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. |
| 22927487 | 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. |
| 17673769 | 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. |
| 20598425 | 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. |
| 28679490 | 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. |
| 29487076 | 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. |
| 31743149 | 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. |
| 22809908 | 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. |
| 28288655 | 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. |
| 20098128 | 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. |
| 21411284 | 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. |
| 28336803 | 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. |
| 23319069 | 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. |
| 18172036 | 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. |