SOMNOmedics Clinical Validation Trial

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03307889

Enrollment

Registered

2017-10-12

Start date

2017-08-20

Completion date

2021-01-01

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Perioperative/Postoperative Complications

Keywords

perioperative monitoring

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Inclusion criteria

* Arterial line planned or existing

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement.	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,

Countries

Sweden

Outcome results