Back to resultsStudy of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
Primary Purpose
Leukemia, Lymphoma, Paraproteinemias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
USCOM scan
Fluid Bolus
Sponsored by
About this trial
This is an interventional supportive care trial for Leukemia
Eligibility Criteria
Inclusion Criteria:
-≥ 18 years of age
- English speaker
- Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT
Exclusion Criteria:
- Obstruction of the suprasternal notch that prevents placing the USCOM probe in the correct location
- Tracheostomy or endotracheal tube that prevents placing USCOM probe in the correct location
- Inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the USCOM exam (ex. due to respiratory distress or physiologic reasons)
- Impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Aim 1: Hemodynamically Healthy Patients
Aim 2: Hemodynamically Unstable Patients
Aim 3: Hemodynamically Unstable Patients + Fluid Bolus
Arm Description
Nurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet. Nurse 2 will perform the USCOM second scan within five minutes of Nurse 1's scan and record the values of Vpk and SV on the clinical data sheet. Nurse 1 and 2 will be blinded to each other's scans by using separate clinical data forms
Nurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet. Nurse 2 will also be notified of the hypotensive event, will then perform the USCOM second scan within five minutes of PI's scan and record the values of Vpk and SV on the clinical data sheet. The two USCOM scans will be completed within 10 minutes of the hypotensive episode. Nurse 1 and Nurse 2 will be blinded to each other's scans by using separate clinical data forms.
At the time that an enrolled patient meets one of the following criteria; SBP drops below 95 mmHg or MAP drops below 65 mmHg the PI will be notified to PI to perform the USCOM scan and record the Vpk, SV, systolic blood pressure and mean arterial pressure on the clinical data sheet within 10 minutes of the hypotensive episode, prior to the patient receiving a fluid bolus (fluid bolus is part of standard of care). The USCOM scan will then be repeated within 5 minutes after fluid bolus delivery. Before the hemodynamically unstable patient receives subsequent fluid boluses (multiple boluses are common standard of care), the PI will perform an USCOM scan. Then within 5 minutes after the delivered fluid bolus, the PI will perform another USCOM scan. This will continue, until no further boluses are prescribed.
Outcomes
Primary Outcome Measures
What is the inter-rater agreement between multiple independent USCOM users measuring stroke volume (SV) and peak velocity (Vpk) whose systolic blood pressures (SBPs) and mean arterial pressures (MAPs) are stable (SBP above 95 mmHg and MAP above 65 mmHg)?
Pairs of USCOM measurements from multiple raters for SV and Vpk, both of which are interval-level measures. Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC); our design fits into case 1 using the Shrout and Fleiss (1979) classification system.
What is the inter-rater agreement between multiple independent USCOM users measuring SV and Vpk in hematopoietic malignancy patients whose SBPs drop below 95mmHg or MAPs drop below 65mmHg?
pairs of USCOM measurements from multiple raters for SV and Vpk. We will use the ICC to evaluate rater agreement here, as well, with the same sample size and the same confidence interval. For Aim 2, though, if the second rating cannot be completed within 5 minutes of the first, that episode will be excluded from the study.
In what percentage of patients is fluid bolus administration successful as measured by the current standard of care (MAP) and what is the level of agreement between the standard measure and USCOM readings in determining return to hemodynamic stability?
After two raters have measured SV and Vpk, bolus will be administered. Determining the success of bolus administration, we will simply record whether the clinician judged the bolus to be successful. In addition, one rater will measure SV and Vpk again using USCOM within 5 minutes of bolus administration. We will then calculate the percentage of patients whose stroke volume and peak velocity increased at least 15% after bolus administration using the post-bolus USCOM reading and the same rater's pre-bolus USCOM reading. We chose an increase of 15% based on a review of the research as the threshold that would best indicate a therapeutic response to bolus administration.
Secondary Outcome Measures
Full Information
NCT ID
NCT01755000
First Posted
December 18, 2012
Last Updated
August 30, 2013
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01755000
Brief Title
Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
Official Title
A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood cancers). Additionally, the researchers will learn if the USCOM gives additional information about patients' conditions when their blood pressures drop and they are treated with intravenous fluids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Paraproteinemias, Multiple Myeloma, Myelodysplastic Syndromes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aim 1: Hemodynamically Healthy Patients
Arm Type
Other
Arm Description
Nurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet.
Nurse 2 will perform the USCOM second scan within five minutes of Nurse 1's scan and record the values of Vpk and SV on the clinical data sheet.
Nurse 1 and 2 will be blinded to each other's scans by using separate clinical data forms
Arm Title
Aim 2: Hemodynamically Unstable Patients
Arm Type
Other
Arm Description
Nurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet.
Nurse 2 will also be notified of the hypotensive event, will then perform the USCOM second scan within five minutes of PI's scan and record the values of Vpk and SV on the clinical data sheet.
The two USCOM scans will be completed within 10 minutes of the hypotensive episode.
Nurse 1 and Nurse 2 will be blinded to each other's scans by using separate clinical data forms.
Arm Title
Aim 3: Hemodynamically Unstable Patients + Fluid Bolus
Arm Type
Other
Arm Description
At the time that an enrolled patient meets one of the following criteria; SBP drops below 95 mmHg or MAP drops below 65 mmHg the PI will be notified to PI to perform the USCOM scan and record the Vpk, SV, systolic blood pressure and mean arterial pressure on the clinical data sheet within 10 minutes of the hypotensive episode, prior to the patient receiving a fluid bolus (fluid bolus is part of standard of care).
The USCOM scan will then be repeated within 5 minutes after fluid bolus delivery.
Before the hemodynamically unstable patient receives subsequent fluid boluses (multiple boluses are common standard of care), the PI will perform an USCOM scan. Then within 5 minutes after the delivered fluid bolus, the PI will perform another USCOM scan. This will continue, until no further boluses are prescribed.
Intervention Type
Procedure
Intervention Name(s)
USCOM scan
Intervention Type
Procedure
Intervention Name(s)
Fluid Bolus
Primary Outcome Measure Information:
Title
What is the inter-rater agreement between multiple independent USCOM users measuring stroke volume (SV) and peak velocity (Vpk) whose systolic blood pressures (SBPs) and mean arterial pressures (MAPs) are stable (SBP above 95 mmHg and MAP above 65 mmHg)?
Description
Pairs of USCOM measurements from multiple raters for SV and Vpk, both of which are interval-level measures. Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC); our design fits into case 1 using the Shrout and Fleiss (1979) classification system.
Time Frame
1 day (one time event for patient)
Title
What is the inter-rater agreement between multiple independent USCOM users measuring SV and Vpk in hematopoietic malignancy patients whose SBPs drop below 95mmHg or MAPs drop below 65mmHg?
Description
pairs of USCOM measurements from multiple raters for SV and Vpk. We will use the ICC to evaluate rater agreement here, as well, with the same sample size and the same confidence interval. For Aim 2, though, if the second rating cannot be completed within 5 minutes of the first, that episode will be excluded from the study.
Time Frame
1 day (one time event for patient)
Title
In what percentage of patients is fluid bolus administration successful as measured by the current standard of care (MAP) and what is the level of agreement between the standard measure and USCOM readings in determining return to hemodynamic stability?
Description
After two raters have measured SV and Vpk, bolus will be administered. Determining the success of bolus administration, we will simply record whether the clinician judged the bolus to be successful. In addition, one rater will measure SV and Vpk again using USCOM within 5 minutes of bolus administration. We will then calculate the percentage of patients whose stroke volume and peak velocity increased at least 15% after bolus administration using the post-bolus USCOM reading and the same rater's pre-bolus USCOM reading. We chose an increase of 15% based on a review of the research as the threshold that would best indicate a therapeutic response to bolus administration.
Time Frame
1 day (one time event for patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-≥ 18 years of age
English speaker
Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT
Exclusion Criteria:
Obstruction of the suprasternal notch that prevents placing the USCOM probe in the correct location
Tracheostomy or endotracheal tube that prevents placing USCOM probe in the correct location
Inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the USCOM exam (ex. due to respiratory distress or physiologic reasons)
Impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Parmentier, RN, BSN
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
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