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Completed

NCT Number: NCT05325814

Agreement Between Standard and Continuous Wireless Vital Sign Measurements

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

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Key information

Conditions

Postoperative Patients

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Center for Cancer and Organ Diseases

Copenhagen, 2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Heart rate comparisons

    Time frame: 1.5 hours (measurement interval every 15 min)

    Heart rate (beats per minute) measurements compared between Isansys Lifetouch and standard monitoring (Phillips IntelliVue). Analysed using Bland Altman (BA) analysis to measure mean diference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

  2. Respiratory rate comparisons

    Time frame: 1.5 hours

    Respiratory rate (breaths per minute) measurements compared between Isansys Lifetouch and observed counted measurements. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

  3. SpO2 measurements comparisons wireless vs. standard

    Time frame: 1.5 hours (measurement interval every 15 min)

    SpO2 (percent) measurements compared between Nonin WristOx 3150 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

  4. SpO2 measurements comparisons wireless vs. invasive

    Time frame: 1.5 hours

    SpO2 (percent) measurements compared between Nonin WristOx 3150 and arterial arterial oxygen saturation. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

  5. Pulse rate comparisons

    Time frame: 1.5 hours

    Pulse rate measurements (beats per minute) measures compared between Nonin WristOx 3150 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

  6. Blood pressure comparisons wireless vs. standard

    Time frame: 1.5 hours, every 15 min

    Blood pressure (mmHg) measurements compared between Meditech BlueBp-05 and standard monitoring. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

  7. Blood pressure comparisons, wireless vs. arterial BP

    Time frame: 1.5 hours

    Systolic and diastolic (mmHg) measurements compared between Meditech BlueBp-05 and invasive arterial blood pressure. Analysed using Bland Altman (BA) analysis to measure mean difference and limits of agreement between to methods. The BA analysis is corrected for repeated measures within each subject.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Agreement Between Standard and Continuous Wireless Vital Sign Measurements Following Major Abdominal Surgery: A Clinical Comparison Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2022
Registry last updated
Apr 19, 2022

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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