Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic

NCT05332847 | Completed

• 1 other identifier: 032716SOR
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Changes occurring in the pulmonary vascularity imparts changes to the right heart in patients with pulmonary arterial hypertension (PAH). Importantly changes in RV function correlates with severity of disease and patient outcome. This affords and opportunity to assess patients longitudinally through point of care ultrasonography. Investigators objective was to measure the percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic, and to compared management change rate between patients with PAH who underwent point of care ultrasonography (POCUS) assessment in addition to the routine evaluation, and a control group to which the investigators did not add a test with POCUS in addition to the routine evaluation in the clinic. Methods: Consecutive patients from the PAH clinic in two medical centers were randomized to the POCUS assessment group and the non-POCUS group. The POCUS group received lung, heart, and vascular ultrasound assessments. All other assessments were the same between both groups. Management changes were documented during each of the patients' visits over a three-month interval.

Conditions

POCUS Assessment During Ambulatory PAH Clinic

Outcome Measures

Primary Outcomes (1)

• percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic

  9 monthes

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The intervention group underwent clinical evaluation and a bedside-focused sonographic assessment

Device: POC-US

control group.

NO INTERVENTION

The control group underwent clinical evaluation without POC-US

Interventions

POC-US DEVICE

Point Of Care Ultrasonography (POCUS) is a rapidly evolving bedside modality in which ultrasonography is utilized as a part of the bedside physical examination and the patients' clinical assessment

Also known as: clinic visit evaluations

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with PAH defined by the Updated clinical classification of pulmonary hypertension criteria.
• Age ≥ 18

You may not qualify if:

• Inability to give informed consent.
• Clear evidence of Group 2-5 PH. We will also exclude patients with PAH on the basis of congenital heart disease, liver cirrhosis or suspected pulmonary veno-occlusive disease.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka Medical Center

Beersheba, Negev, 85510, Israel

Location

Related Publications (1)

• Avriel A, Bar Lavie Shay A, Hershko Klement A, Taylor J, Shamia D, Tsaban G, Abu-Shakra M, Granton J, Fuchs L. Point-of-Care Ultrasonography in a Pulmonary Hypertension Clinic: A Randomized Pilot Study. J Clin Med. 2023 Feb 22;12(5):1752. doi: 10.3390/jcm12051752.

  PMID: 36902536 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmonary Hypertension clinic

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: April 18, 2022
• Study Start: January 14, 2018
• Primary Completion: March 11, 2019
• Study Completion: June 30, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

IL (1)