Critically IllNCT01311128
Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
An observational study of Critically Ill, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- T-line hemodynamic monitoring device (placement and use)
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2011to 30 Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years old
- Operative patients expected to require intensive care recovery at OHSU
- Planned or existing intra- and postoperative radial artery catheterization as part of routine care
- Palpable contralateral (to catheter) radial artery pulse
- Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total
Who cannot join
- No palpable radial artery pulse
- Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site
- An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor
- An AV shunt in the T-line arm
- Known sensitivity to pressure stimuli (dermatographism)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients.
Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.
- Conditions
- Critically Ill
- Being tested
- T-line hemodynamic monitoring device (placement and use)
- Keywords
- Blood pressure, Heart rate, Cardiac output, Critical care, Perioperative care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-line hemodynamic monitoring device (placement and use)Device
Also called T-line, Tensymeter, Tensys Medical, Inc., Hemodynamic monitoring
The T-line device will be placed over the contralateral (from the radial artery catheter) radial artery at the distal wrist. To attach the device, a single-use sterile sensor is placed over the radial artery and the device then gently clamped around the wrist to incorporate the sensor. After a ten-minute stabilization period, data will be recorded every ten minutes during the first two hours of surgery, or until the patient is placed on cardiopulmonary bypass. The T-line device will then be removed. This procedure will be repeated, for a second two-hour period, in the ICU postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Heart rate and blood pressure determination | All subjects have the same conditions (T-line, blood pressure cuff, and radial artery catheter), in order to compare them within-subjects. Receives: Device: T-line hemodynamic monitoring device (placement and use) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure
Measured: Assessed 24 times over four hours
Secondary outcomes (1)
Agreement between the T-line and right heart catheter in determining cardiac output
Measured: Assessed every 30 minutes over four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study start16 Feb 2011
- Primary completion29 Jun 2012
- Study completion30 Dec 2014
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Phillips, MD, Principal investigator, 503-494-2465
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311128
- Sponsor's protocol ID
- 6980
- Status last verified
- Aug 2019
- First submitted
- 8 Mar 2011
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
- ClinicalTrials.gov ID
- NCT01311128
- Acronym / sponsor ID
- 6980
- Conditions
- Critically Ill
- Keywords
- Blood pressure, Heart rate, Cardiac output, Critical care, Perioperative care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 16 Feb 2011 (actual)
- Primary completion
- 29 Jun 2012 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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.
This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients.
Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart rate and blood pressure determination | – | Device: T-line hemodynamic monitoring device (placement and use)All subjects have the same conditions (T-line, blood pressure cuff, and radial artery catheter), in order to compare them within-subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at least 18 years old
- Operative patients expected to require intensive care recovery at OHSU
- Planned or existing intra- and postoperative radial artery catheterization as part of routine care
- Palpable contralateral (to catheter) radial artery pulse
- Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total
Key exclusion criteria (5 listed)
- No palpable radial artery pulse
- Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site
- An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor
- An AV shunt in the T-line arm
- Known sensitivity to pressure stimuli (dermatographism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-line hemodynamic monitoring device (placement and use)Also: T-line, Tensymeter, Tensys Medical, Inc., Hemodynamic monitoringThe T-line device will be placed over the contralateral (from the radial artery catheter) radial artery at the distal wrist. To attach the device, a single-use sterile sensor is placed over the radial artery and the device then gently clamped around the wrist to incorporate the sensor. After a ten-minute stabilization period, data will be recorded every ten minutes during the first two hours of surgery, or until the patient is placed on cardiopulmonary bypass. The T-line device will then be removed. This procedure will be repeated, for a second two-hour period, in the ICU postoperatively. | Device | Heart rate and blood pressure determination |
Primary outcome
Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure
Time frame: Assessed 24 times over four hours
1 secondary outcome
Agreement between the T-line and right heart catheter in determining cardiac output
Time frame: Assessed every 30 minutes over four hours
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Charles Phillips, MD principal investigator
503-494-2465
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 Critically Ill, run by Oregon Health and Science University at 1 site in United States.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Aug 2019. 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 United States. 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 was stopped early (reason given: PI left institution). Results are not available in the source record.
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?
Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure (time frame: Assessed 24 times over four hours). 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 28 Aug 2019.