SOMNOmedics Clinical Validation Trial
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|ClinicalTrials.gov Identifier: NCT03307889|
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : November 17, 2017
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 or disease|
|Blood Pressure Perioperative/Postoperative Complications|
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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.|
|Actual Study Start Date :||August 20, 2017|
|Estimated Primary Completion Date :||July 1, 2018|
|Estimated Study Completion Date :||August 1, 2018|
- 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,
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
|Contact: Jan Colldén, MDfirstname.lastname@example.org|
|Uppsala, Upp, Sweden, 75385|
|Contact: Dept head Odeberg Wernerman, MD PhD +46186110000|
|Principal Investigator:||Michael Hultström, Ass Prof||University of Uppsala|