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Diaphragm Paralysis: Surgery or Mechanical Ventialion

NCT05027035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-11

No results posted yet for this 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.

Conditions

  • Diaphragm Paralysis

Interventions

OTHER

surgical plication" or "nocturnal non-invasive ventilation

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Peter Wijkstra, prof · UMCG

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05027035 on ClinicalTrials.gov