Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings

The Washington University

Status: Completed

Conditions: Multiple Myeloma; Paraproteinemias; Lymphoma; Leukemia; Myelodysplastic Syndromes

Treatments: Procedure: USCOM scan; Procedure: Fluid Bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT01755000

201206070

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

Aim 1: Hemodynamically Healthy Patients

Other group

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

Treatment:

Procedure: USCOM scan

Aim 2: Hemodynamically Unstable Patients

Other group

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.

Treatment:

Procedure: USCOM scan

Aim 3: Hemodynamically Unstable Patients + Fluid Bolus

Other group

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.

Treatment:

Procedure: Fluid Bolus

Procedure: USCOM scan