SOMNOmedics Clinical Validation Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-20

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Blood Pressure Perioperative/Postoperative Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Arterial line planned or existing

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Michael Hultström

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Hultström, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Akademiska Sjukhuset

Uppsala, Upp, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EPN dnr 2017/068

Identifier Type: -

Identifier Source: org_study_id