Inpatient Facililty Diagnoses
Conditions
Keywords
inpatients, wireless monitoring, mortality, cardiopulmonary failure
Brief summary
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
DEVICEwireless 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).
Sponsors
King Abdullah International Medical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ward level Inpatient wards, defined as wards used to manage adult inpatients. Patient level 1. Aged 14 years or older 2. Checked in as inpatient status to one of the study wards
Exclusion criteria
Ward level 1. Cardiology, pediatric, obstetric wards 2. ICUs and emergency departments 3. Operating rooms 4. Outpatient clinics 5. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation | 30 days | After hospital admission within 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac arrest | 30 days | cardiac arrest within 30 days of hospital admission |
| Requirement of vasopressors | within 30 days of hospital admission | use of vasopressors/inotropic support |
| Requirement of intubation | 30 days | need for mechanical ventilation within 30 days of hospital admission |
| Hospital length of stay | 90 days | censored at 90 days |
| Transfer to ICU | 30 days | ICU admission within 30 days of hospital admission |
| ICU- free days | 30 days | in the first 30 days of hospital admission |
| CCRT activation | 30 days | Critical care response team activation within 30 days of hospital admission |
Countries
Saudi Arabia
Contacts
CONTACTYaseen M Arabi, MD
Outcome results
None listed