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

Sponsor
Ayham Daher (Other)
Overall Status
Recruiting
CT.gov ID
NCT04993612
Collaborator
(none)
100
1
36.2
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood gas analysis

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization
Actual Study Start Date :
Jun 25, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
No pulmonary Hypertension

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.

pulmonary Hypertension Group 1

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.

pulmonary Hypertension Group 2

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.

pulmonary Hypertension Group 3

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.

pulmonary Hypertension Group 4

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.

pulmonary Hypertension Group 5

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.

Outcome Measures

Primary Outcome Measures

  1. Risk group after 3-6 months [3-6 months]

    Standardized clinical outcome parameters after 3-6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital RWTH Aachen Aachen Germany 52062

Sponsors and Collaborators

  • Ayham Daher

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ayham Daher, Principal Investigator, RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT04993612
Other Study ID Numbers:
  • 21-063
First Posted:
Aug 6, 2021
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022