Blood PressureNCT03307889
SOMNOmedics Clinical Validation Trial
An observational study of Blood Pressure and Perioperative/Postoperative Complications, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Pressure, Perioperative/Postoperative Complications
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 20 Aug 2017to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Pediatric and adult patients in anesthesia or intensive care.
Who may be able to join
- Arterial line planned or existing
Who cannot join
- suspected major perioperative hemodynamic variation.
- non existing consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.
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.
Read the 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.
- Keywords
- perioperative monitoring
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 45 minutes- 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start20 Aug 2017
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hultström, Uppsala University
- Investigators
- Michael Hultström, Ass Prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307889
- Sponsor's protocol ID
- EPN dnr 2017/068
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOMNOmedics Clinical Validation Trial of Pulse Transit Time (PTT) Compared With Arterial Line in Patients Undergoing Nonvascular Surgery.
- ClinicalTrials.gov ID
- NCT03307889
- Acronym / sponsor ID
- EPN dnr 2017/068
- Keywords
- perioperative monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients in anesthesia or intensive care.
Key inclusion criteria (1 listed)
- Arterial line planned or existing
Key exclusion criteria (2 listed)
- suspected major perioperative hemodynamic variation.
- non existing consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Yes. Anonymous data will be made available to interested researchers after publication. The patients are informed of this fact.
Related trials for Blood Pressure
Recruiting
Smartwatch-based Intervention for Cardiovascular Health (SWITCH)
Overweight , Obesity, Prediabetes
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
Not yet recruiting
Equivalence of Systolic Blood Pressure Measurements Between Fowler and Seated Positions
Blood Pressure Measurement
Not yet recruitingObservational study
Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke
Ischemic Stroke, Acute, Blood Pressure Variability
RecruitingObservational study
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Blood Pressure Measurement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hultström, Ass Prof principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Perioperative/Postoperative Complications, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of pulse transit time (PTT) estimation of blood pressure against intra arterial measurement. (time frame: 45 minutes- 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.