Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT05027035
Eligibility Criteria:
Inclusion Criteria:
* \>18 years
* diagnosed with a unilateral diaphragm paralysis based on isolated phrenic nerve injury.
Unilateral diaphragm paralysis is defined as follows: complaints of dyspnea and / or orthopnea combined with a drop in VC of more than 15% when change from upright to supine position and a positive sniff test during fluoroscopy or ultrasonography. A positive sniff test means that the diaphragm stands still or even moves in cranial direction (paradoxical movement ) during the sniff inspiratory maneuver.
* Ability to provide written consent
* Time between diagnosis and treatment should be at least 1 year
Exclusion Criteria:
* Patients diagnosed with a bilateral diaphragm paralysis.
* A diaphragm paralysis in combination with a more systemic neurological or neuromuscular disorder like for example Amyotrophic Lateral Sclerosis ,
* Hypercapnia during daytime (PaCO2 \> 6.0 kPa)
* Radiotherapy of the thorax
* Contra indication for diaphragm surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05027035
Study Brief:
Protocol Section:
NCT05027035