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POCUS Assessment During Ambulatory PAH ClinicPOCUSPAHNCT05332847

Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic

A study testing POC-US in people with POCUS Assessment During Ambulatory PAH Clinic, run by Soroka University Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
POC-US
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteIsrael
Study dates
14 Jan 2018to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients with PAH defined by the Updated clinical classification of pulmonary hypertension criteria.
  • Age ≥ 18
  • Baseline values from right-heart catheterization results for the definite diagnosis of PH: Hemodynamic inclusion: resting mPAP > 25mmHg, PCWP < 15mmHg, and PVR > 3 Woods Units.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Soroka Medical Center

    Beersheba, Negev, 85510

Other trials in Israel

About this study

Official title: Point of Care Ultrasonography Assessment During Pulmonary Hypertension Clinic Changes Patients' Management- A Randomized Controlled Pilot Study

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.

Read the detailed description

The investigators included patients if they were diagnosed with group 1 PH (PAH), as defined by the updated clinical classification of PH and provided informed consent. Patients were excluded if diagnosed with PH group 2-5, had congenital heart disease, liver cirrhosis, or suspected pulmonary venous-occlusive disease. On enrollment, randomization of the patient was done 1:1 (using ClinStat) to either the POCUS assessment group or control group. Both groups underwent the same clinical assessment according to PH clinic protocol and by the same treating pulmonologist (A.A.). Every patient was scheduled to a follow up meeting every three months as part of the usual PAH clinic routine. The study protocol was approved by each participating center's research ethics board (BRZ 0106-18, SOR0327-16).

At each clinic visit evaluations for both groups were standardized. Each visit included a history, physical and laboratory evaluation, BNP level, 6-minute walk test, and quality of life as assessed using emPHasis 10.

Prior to the decision regarding patient management, the pulmonologist at the PAH clinic knew the test results including a POCUS test done in the intervention group. A change in the patient's management in the clinic is represented by the clinician's recommendation for a change in medication, sending the patient for a lung transplant, hospitalization, or other diagnostic or therapeutic procedure documented

Patients in the intervention group underwent a bedside-focused sonographic assessment of the heart, lungs, abdomen, and IVC in every clinic visit during the period of study. The exam was conducted either at the beginning or after the regular patient assessment. The Investigators used 2-dimensional views, the parasternal long and short axis, subcostal long and IVC, apical 5, 4, 2 chamber view. As this exam was POCUS centered and not a formal cardiac study. When pathologies were identified, relevant measurements were made, and the patient was referred for a formal echo. For example, when a calcified aortic valve was detected, and aortic stenosis was suspected a continuous pulse wave Doppler for maximal velocity measurement was conducted. Standard measurements were for left ventricle wall thickness, size of ventricles and atria, IVC size and collapsibility index, RVSP when TR was identified, TAPSE, and size of pericardial effusion when found. Lung ultrasound was focused on the detection of pulmonary congestion (screening and counting B-lines on both lungs, midclavicular line and midaxillary line), pleural effusion, lung atelectasis, lung consolidations (mid and posterior axillary lines), and sliding of pleura (midclavicular line). The investigators performed Doppler for DVT only within the right clinical context. All POCUS exams were documented in a standardized form. Findings were reported in real-time to the treating pulmonologist and were documented in the follow-up notes.

Being tested
POC-US

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POC-USDevice

    Also called clinic visit evaluations

    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

Study groups in NCT05332847
Study groupRoleWhat they receive
intervention groupActive comparatorThe intervention group underwent clinical evaluation and a bedside-focused sonographic assessment
Receives: Device: POC-US
control group.No interventionThe control group underwent clinical evaluation without POC-US

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 9 monthes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start14 Jan 2018
  3. Primary completion11 Mar 2019
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332847
Sponsor's protocol ID
032716SOR
Acronym
POCUSPAH
Status last verified
Apr 2022
First submitted
13 Mar 2022
Last updated
18 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36902536

Questions about this trial

What is this clinical trial studying?

A study testing POC-US in people with POCUS Assessment During Ambulatory PAH Clinic, run by Soroka University Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage and the rate of patients management change, represented by change in treatment or assessment of patients in the PAH clinic (time frame: 9 monthes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05332847, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.

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