SOMNOmedics Clinical Validation Trial

SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.

Observational study in which pulse transit time (PTT) as a method and the device to register this data is compared with arterial blood pressure.

The population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Perioperative/Postoperative Complications

Detailed Description

Plan to enroll patients who accept the terms of the study consecutively. The population is composed by pediatric and adult patients in anesthesia and intensive care in need of close blood pressure monitoring.

After informed consent from the patients themselves, patient and parents and sometimes only parents.

The device measuring PTT is the prepared and calibrated with existing arterial blood pressure. Data is then recorded via the storage capacity of the device and via videocamera. The videocamera is used to identify large disturbances in data registration. This is to identify confounding data and in the end calibrate the device to be more accurate.

Data from the PTT device and the camera is then downloaded to the study computer and to an external hard drive in order to create redundancy in data storage.

Data is then analysed to compare the difference between data recorded from the PTT device and arterial pressure respectively. Aim is to be able to collect sufficient data to be able to decide wether to recommend or advice against clinical use.

Patient data is registered and then handled by our departmental clerk. Data is stored for ten years.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Sweden
  • Upp
    • Uppsala, Upp, Sweden, 75385
      • Akademiska sjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients in anesthesia or intensive care.

Description

Inclusion Criteria:

• Arterial line planned or existing

Exclusion Criteria:

• suspected major perioperative hemodynamic variation.
• non existing consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.	Difference in mmHg between blood pressure calculated by PTT and arterial blood pressure. A video will record the measurement session in order to determine any action correlating to changes in blood pressure. A second use of the video is to determine what other action taken around the patient causing noise or confounding measurements,	45 minutes- 120 minutes

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Michael Hultström, Ass Prof, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 16, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: perioperative monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: EPN dnr 2017/068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.
• IPD Sharing Time Frame: Supporting information will be made available after publication.
• IPD Sharing Access Criteria: Data and supporting information will be made available to interested researchers upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR