Recruiting

Wireless Continuous Vital Sign Monitoring in Adult Spinal Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Wireless monitoring

Device
Who is being recruted

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorRigshospitalet, Denmark
Study ContactCamilla Hedegaard Larsen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 10, 2025

Actual date on which the first participant was enrolled.

This study focuses on patients who have undergone adult spinal deformity surgery, which often comes with high complication rates and long recovery times. Traditional methods of monitoring these patients involve intermittent checks, which might miss important changes in their condition. This study aims to explore the feasibility of using a wireless continuous vital sign monitoring system, known as wCVSM, to keep a closer eye on patients' vital signs in real-time. This technology could potentially improve patient safety by allowing healthcare providers to respond quickly to any signs of clinical deterioration. The study also seeks to understand how acceptable this new technology is to both nurses and patients, which is crucial for its successful implementation in healthcare settings. Participants in this study will wear a device called CPC12S, which is a chest sensor that continuously measures vital signs like heart rate, respiratory rate, blood oxygen levels, blood pressure, and temperature. These readings are updated every 20 seconds and transmitted to a secured server. Nurses will use this data to monitor patients more effectively. The study will evaluate various aspects, including how well nurses and patients receive the technology, the reliability of the system, and how frequently it detects vital sign deviations compared to traditional methods. By analyzing these factors, the study aims to provide insights into the potential benefits and challenges of integrating continuous monitoring technology in postoperative care.

Official TitleFeasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General Ward
NCT07105189
Principal SponsorRigshospitalet, Denmark
Study ContactCamilla Hedegaard Larsen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Included are adult patients (>=18 years) scheduled for ASD surgery with estimated a >3 day expected post-operative stay. ASD-surgery is defined as a posterior instrumented fusion of at least five spinal levels including instrumentation to the pelvis, caused by a degenerative condition of the spine.

Registered nurses and nurses' assistants employed at the orthopedic ward during the study period will be included if they have experience working with wCVSM during the study period. The study includes both sexes, variation of level of education and years of work experience. Included nurses and nurses' assistants should be proficient in the Danish language.

2 exclusion criteria prevent from participating
Exclusion criteria are patients who are unable to wear continuous monitoring due to a pacemaker or allergy.

Patients who are not proficient in the Danish language will be excluded.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this arm will receive a wearable wireless continuous vital sign monitoring system (CPC12S), applied after spinal deformity surgery and worn during the initial postoperative period (typically 3-5 days). The device transmits data wirelessly to a mobile application accessed by nursing staff.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen

Copenhagen, DenmarkOpen Department of Bone and Joint surgery, University hospital, Rigshospitalet, Copenhagen in Google Maps
Recruiting
One Study Center