SOMNOmedics Clinical Validation Trial

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307889
• Other study ID #: EPN dnr 2017/068
• Status: Completed
• Start date: August 20, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: October 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Arterial line planned or existing

Exclusion Criteria:

• suspected major perioperative hemodynamic variation.

• non existing consent.

Related Conditions & MeSH terms

• Blood Pressure
• Perioperative/Postoperative Complications
• Postoperative Complications

Locations

Country	Name	City	State
Sweden	Akademiska Sjukhuset	Uppsala	Upp

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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