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NCT Number: NCT06644599

Wireless Monitoring for Clinical Deterioration

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

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Key information

Conditions

Inpatient Facililty Diagnoses

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Riyadh, Riyadh Region, Saudi Arabia

Location status: Recruiting

Location contact

Yaseen M Arabi, MD, FCCP, FCCM, ATSF

CONTACT

[email protected]

+966 (11) 801-1111 ext. 18855

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

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

    Time frame: 30 days

    After hospital admission within 30 days

Secondary outcomes

  1. Cardiac arrest

    Time frame: 30 days

    cardiac arrest within 30 days of hospital admission

  2. Requirement of vasopressors

    Time frame: within 30 days of hospital admission

    use of vasopressors/inotropic support

  3. Requirement of intubation

    Time frame: 30 days

    need for mechanical ventilation within 30 days of hospital admission

  4. Hospital length of stay

    Time frame: 90 days

    censored at 90 days

  5. Transfer to ICU

    Time frame: 30 days

    ICU admission within 30 days of hospital admission

  6. ICU- free days

    Time frame: 30 days

    in the first 30 days of hospital admission

  7. CCRT activation

    Time frame: 30 days

    Critical care response team activation within 30 days of hospital admission

Study contacts

Contact information is provided by the study sponsor or research team.

Yaseen M Arabi, MD

CONTACT

[email protected]

018011111 ext. 18899

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Official study title

Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial

Acronym: i-PROTECT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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