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Clinical Trials in the Netherlands / NCT05027035
Recruiting Not applicable

Diaphragm Paralysis: Surgery or Mechanical Ventialion

NCT05027035 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University Medical Center Groningen
Phase
Not applicable
Started
2024-06-28
Last updated
2024-12-11

Condition(s) studied

Diaphragm Paralysis

Investigational drug(s) / intervention(s)

surgical plication" or "nocturnal non-invasive ventilation

surgical plication" or "nocturnal non-invasive ventilation: 10 participants for surgical plication and 10 participants for nocturnal non-invasive ventilation.

Study summary

Summary Rationale: The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. In patients with diaphragm paralysis the treatment (surgery versus non-invasive ventilation) is based on physician preference, not sound scientific evidence. Clearly studies are needed to guide a scientific decision making.

Objective: In this pilot study the we want to know the clinical relevant effect of both therapies on EQ-5D\_5L, the latter being the primary outcome. Finally, it will show the investigators the costs of both therapies form a societal perspective.

Study design: open-label, multi center intervention pilot study Study population: 20 participants \>18 year and diagnosed with a unilateral diaphragm paralysis resulting from phrenic nerve injury.

Intervention: 10 participants for surgical plication and 10 participants for nocturnal non-invasive ventilation while on the wating list for surgical plication.

Main study parameters/endpoints:

The goal of the pilot study is to describe the effect of both plication and NIV on the endpoints of the intended efficiency study. The intended primary endpoint is quality of life as measured by the EQ-5D-5L questionnaire. Secondary endpoints are; the Medical Research Council (MRC) dyspnoea scale, the Diaphragmatic Paralysis Questionnaire, Borg dyspnoea score, 6 minute walk test, spirometry in both sitting and supine position, a polysomnography and transcutaneous measurement of carbon dioxide an oxygen saturation at night.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Comparing surgical plication versus non-invasive ventilation . — 0-15 months
    10 patients surgical plication and 10 patients non-invasive ventilation while on the waiting list
  • Change in EuorQOL 5 Dimensions 5 Level (EQ-5D-5L questionnaire) range 1-1-1-1-1 (best score) to 5-5-5-5-5 (worst score) — baseline and 3 and 6 months
    questionnaire to score QUALY

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Groningen Groningen Netherlands 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 NCT05027035 on ClinicalTrials.gov ↗ ← All trials in the Netherlands