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A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings


N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma, Paraproteinemias, Multiple Myeloma, Myelodysplastic Syndromes

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Trial Information

A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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)?

Outcome 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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Michelle Parmentier, RN, BSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

201206070

NCT ID:

NCT01755000

Start Date:

December 2012

Completion Date:

August 2013

Related Keywords:

  • Leukemia
  • Lymphoma
  • Paraproteinemias
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Paraproteinemias
  • Hematologic Neoplasms

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110