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SOMNOmedics Clinical Validation Trial

This study is currently recruiting participants.
Verified November 2017 by Michael Hultström, Uppsala University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03307889
First Posted: October 12, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Hultström, Uppsala University
  Purpose

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.


Condition
Blood Pressure Perioperative/Postoperative Complications

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.

Further study details as provided by Michael Hultström, Uppsala University:

Primary Outcome Measures:
  • Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement. [ Time Frame: 45 minutes- 120 minutes ]
    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,


Estimated Enrollment: 120
Actual Study Start Date: August 20, 2017
Estimated Study Completion Date: August 1, 2018
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Pediatric and adult patients in anesthesia or intensive care.
Criteria

Inclusion Criteria:

  • Arterial line planned or existing

Exclusion Criteria:

  • suspected major perioperative hemodynamic variation.
  • non existing consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307889


Contacts
Contact: Jan Colldén, MD +46186113422 jan.collden@akademiska.se

Locations
Sweden
Akademiska Sjukhuset Recruiting
Uppsala, Upp, Sweden, 75385
Contact: Dept head Odeberg Wernerman, MD PhD    +46186110000      
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Michael Hultström, Ass Prof University of Uppsala
  More Information

Responsible Party: Michael Hultström, Associate professor, Uppsala University
ClinicalTrials.gov Identifier: NCT03307889     History of Changes
Other Study ID Numbers: EPN dnr 2017/068
First Submitted: October 6, 2017
First Posted: October 12, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Supporting information will be made available after publication.
Access Criteria: Data and supporting information will be made available to interested researchers upon request.

Keywords provided by Michael Hultström, Uppsala University:
perioperative monitoring

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes