Agreement Between Standard and Continuous Wireless Vital Sign Measurements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2020-07-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients undergoing major surgery are at risk of postoperative complications. Continuous wireless monitoring outside the post-anesthesia or intensive care units may enable early detection of patient deterioration, but good accuracy of measurements is required.

This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study

NCT04628858

Complication of Surgical Procedure Complication of Anesthesia Respiratory Complication +1 more

COMPLETED

Use of Wearables for Early Detection of Complications After Major Acute Abdominal Surgery

NCT04257344

Surgery--Complications Abdomen Disease

COMPLETED

Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward

NCT07105189

Adult Spinal Deformity Wireless Continuous Vital Signs Monitoring Wireless Vital Signs Monitoring System +4 more

RECRUITING NA

Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients

NCT06227208

Medical Complication

COMPLETED

Registry Construction of Intraoperative Vital Signs and Clinical Information in Surgical Patients

NCT02914444

Anesthesia Monitoring, Intraoperative

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients undergoing major surgery are at risk of postoperative complications. Complications may be preceded by abnormal vital signs. Standard monitoring at general wards is intermittent and manual, leaving the patients unobserved for extended periods.

The chance to enhance monitoring has arisen with recent technological advances in the form of small wearable and wireless devices that continuously record vital signs. Wearable devices enable continuous monitoring outside the intensive care unit and post-anesthesia care unit, thus enabling early detection of patient deterioration. However, before implementing such devices in hospital settings, good accuracy, and precision of measurements is required.

This validation study, which is part of the WARD-SX project, aimed to assess the agreement between vital signs recorded by standard and novel wireless devices

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Device: Continuous monitoring system

Continuous monitoring system Recruited patients will be continuously monitored with Isansys Lifetouch patch, Nonin WristOx 3150, Isansys wireless blood pressure monitor (Meditech Blue BP-05) and standard monitoring at the post anesthesia care unit

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥60 years, scheduled for major abdominal cancer surgery with planned PACU admission.

Estimated surgical intervention duration ≥2 hours.

Exclusion Criteria

* Implanted cardioverter defibrillator or pacemaker, allergy to study devices, severe cognitive impairment assessed by Mini-Mental State Examination ≤24, or inability to cooperate in wearing the wireless monitoring equipment.

Minimum Eligible Age

60 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No