Wireless Monitoring for Clinical Deterioration

N/ANot Yet RecruitingNCT06644599

King Abdullah International Medical Research Center13,160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

13,160

Conditions

Inpatient Facililty Diagnoses

Interventions

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).

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

After hospital admission within 30 days

Time frame: 30 days

Secondary Outcomes

Cardiac arrest

cardiac arrest within 30 days of hospital admission

Time frame: 30 days

Requirement of vasopressors

use of vasopressors/inotropic support

Time frame: within 30 days of hospital admission

Requirement of intubation

need for mechanical ventilation within 30 days of hospital admission

Time frame: 30 days

Hospital length of stay

censored at 90 days

Time frame: 90 days

Transfer to ICU

ICU admission within 30 days of hospital admission

Time frame: 30 days

ICU- free days

in the first 30 days of hospital admission

Time frame: 30 days

CCRT activation

Critical care response team activation within 30 days of hospital admission

Time frame: 30 days

Central Contacts

Yaseen M Arabi, MD

CONTACT

018011111 arabi@mngha.med.sa

Data from ClinicalTrials.gov

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