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Clinical Trials/NCT04993612
NCT04993612RecruitingNot Applicable

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

Ayham Daher1 site in 1 country100 target enrollmentStarted: June 25, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Between group differences

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

No pulmonary Hypertension

Intervention: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 1

Intervention: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 2

Intervention: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 3

Intervention: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 4

Intervention: Blood gas analysis (Diagnostic Test)

pulmonary Hypertension Group 5

Intervention: Blood gas analysis (Diagnostic Test)

Outcomes

Primary Outcomes

Between group differences

Time Frame: At the time of recruitment

Differences in the Wedge-BGA between groups

Secondary Outcomes

  • Follow-up(1 and 5 years)

Investigators

Sponsor
Ayham Daher
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ayham Daher

Principal Investigator

RWTH Aachen University

Study Sites (1)

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