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

Pulmonary Hypertension Clinical Trial

Official title:

Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993612
• Other study ID #: 21-063
• Status: Recruiting
• Start date: June 25, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
Ayham Daher

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk group after 3-6 months	Standardized clinical outcome parameters after 3-6 months	3-6 months