Evaluation of Feasibility of Ultrasonography Guided Pulmonary Artery Catheterization in Pulmonary Hypertension Diagnosis

NCT07154927 | Not Yet Recruiting

• 1 other identifier: ASSIUTMOSTAFAKAHMED
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pulmonary artery catheters (PACs) that called Swan-Ganz catheters provide valuable information in select patient's especially pulmonary hypertension patiens. PACs are indicated for assessment of cardiopulmonary hemodynamics in specific groups of patients presenting with pulmonary hypertension, pulmonary embolism or shock \[1\]. They can be inserted at bedside under sterile conditions and provide valuable information that can add benefit for measures recorded with transthoracic echocardiography. The advancement of PACs in a patient is usually performed by flotation of a balloon tipped catheter under pressure waveform guidance. The balloon tip floats in blood and is directed into the pulmonary artery by the normal flow from superior vena cava and through the right heart chambers into pulmonary artery. The correct positioning is needed for safe use and accurate cardiopulmonary hemodynamics measurement. The use of blind approach of insertion can be challenging in patients with slow blood flow as pulmonary hypertension patients. The abnormal flow can induce the PAC to coil in cardiac chambers such as right atrium and right ventricle or be misdirected to the inferior vena cava. Repeated attempts to retract and redirect the catheter can increase the risk of complications and should be avoided \[2\]. The use of fluoroscopic guidance persists in these cases. Fluoroscopy when used alongside pressure waveform analysis has been noted to reduce the time to wedge, number of attempts and composite complication rate in patients undergoing pulmonary hemodynamic assessment. Also, fluoroscopy provides real time visualization that can lead to reduction of catheter malposition and ventricular arrhythmias. Unfortunately, it is not available in all pulmonary hypertension units for bedside insertion and hemodynamics evaluation. The use of fluoroscopy can led to unnecessary radiation exposure to both the patient and the procedure team. Sonographic guided pulmonary catheter insertion is interesting technique ; however it still needed to be studied in pulmonary hypertension patients in pulmonary hypertension unit

Conditions

Pulmonary Hypertension

Keywords

pulmonary artery catheterization , ultrasonography guidance

Outcome Measures

Primary Outcomes (1)

• Success rate** of PAC placement using ultrasound guidance alone

  Time to catheter placement (in minutes) * Incidence of complications (major and minor) * Accuracy of hemodynamic parameters compared to standard reference * Learning curve evaluation over time

  procedure time from starting patient puncture till procedure end (PAC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pulmonary hypertension patients refered to our pulmonary hyperetnsion unit for PAC

You may qualify if:

• Adults (≥18 years)
• Clinically suspected PH referred for diagnostic RHC
• Informed consent provided

You may not qualify if:

• Hemodynamic instability requiring immediate intervention
• Poor echocardiographic window despite TTE/TEE
• Contraindications to catheterization
• Known intracardiac shunts or severe tricuspid regurgitation (if it impairs catheter tracking)
• iteria: -

Sponsors & Collaborators

• Mostafa K. Ahmed: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• mostafa K Ahmed, MD

  Assiut University pulmonary hypertension Unit Chest Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assiut University Faculty of Medicine chest departement pulmonary hypertension Unit

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08