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Clinical Trials in Germany / NCT04993612
Recruiting Observational

Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)

NCT04993612 · tracked via the Priya Life Science Germany tracker
Sponsor
Ayham Daher
Phase
Observational
Started
2021-06-25
Last updated
2026-02-06

Condition(s) studied

Pulmonary Hypertension

Investigational drug(s) / intervention(s)

Blood gas analysis

Blood gas analysis: Two blood samples will be drawn from the "wedge" position", behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later.

Study summary

If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Patients who have a clearly defined indication for Right heart catheterization. * Age \> 18 years * Informed consent for participation in the study will sign Exclusion Criteria: * Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study * Pregnancy and lactation * Wedge-BGA not possible

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital RWTH Aachen Aachen Germany Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04993612 on ClinicalTrials.gov ↗ ← All trials in Germany