Agreement Between Standard and Continuous Wireless Vital Sign Measurements

NCT05325814 | Completed DMC

• 1 other identifier: WARD_SX_validation
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Patients

Keywords

wearable devices; continuous; comparison study; validation

Outcome Measures

Primary Outcomes (7)

• Heart rate comparisons

  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.

  1.5 hours (measurement interval every 15 min)

• Respiratory rate comparisons

  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.

  1.5 hours

• SpO2 measurements comparisons wireless vs. standard

  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.

  1.5 hours (measurement interval every 15 min)

• SpO2 measurements comparisons wireless vs. invasive

  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.

  1.5 hours

• Pulse rate comparisons

  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.

  1.5 hours

• Blood pressure comparisons wireless vs. standard

  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.

  1.5 hours, every 15 min

• Blood pressure comparisons, wireless vs. arterial BP

  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.

  1.5 hours

Study Arms (1)

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

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planned for major abdominal surgery at Bispebjerg and Frederiksberg, and Rigshospitalet.

You may qualify if:

• ≥60 years, scheduled for major abdominal cancer surgery with planned PACU admission.
• Estimated surgical intervention duration ≥2 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Anesthesiology, Center for Cancer and Organ Diseases

Copenhagen, 2100, Denmark

Location

Study Officials

• Eske K Aasvang, Dr. Med

  Rigshospitalet, Denmark

  STUDY CHAIR

• Camilla Haahr-Raunkjaer, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 13, 2022
• Study Start: December 18, 2019
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

DK (1)