Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Oregon Health and Science University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01311128
First received: March 8, 2011
Last updated: May 27, 2011
Last verified: March 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 8, 2011 | ||||||||
| Last Updated Date | May 27, 2011 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01311128 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Agreement between the T-line and right heart catheter in determining cardiac output [ Time Frame: Assessed every 30 minutes over four hours ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device | ||||||||
| Official Title ICMJE | Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Critically Ill | ||||||||
| Intervention ICMJE | Device: T-line hemodynamic monitoring device (placement and use)
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 intervention will be repeated, for a second two-hour period, in the ICU postoperatively.
Other Names:
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| Study Arm (s) | Experimental: 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.
Intervention: Device: T-line hemodynamic monitoring device (placement and use) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01311128 | ||||||||
| Other Study ID Numbers ICMJE | 6980 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Charles Phillips, MD, Oregon Health & Science University | ||||||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Oregon Health and Science University | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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