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Completed

NCT Number: NCT03307889

SOMNOmedics Clinical Validation Trial

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Akademiska Sjukhuset

Uppsala, Upp, 75385, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Arterial line planned or existing

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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,

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2017
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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