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Diaphragm; Paralysis clinical trials

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NCT ID: NCT05027035 Recruiting - Diaphragm Paralysis Clinical Trials

Diaphragm Paralysis: Surgery or Mechanical Ventialion

PARASOL
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04783064 Completed - Clinical trials for Diaphragm; Paralysis

Neck Anatomy and Phrenic Nerve Palsy After BPB

Start date: March 17, 2021
Phase:
Study type: Observational

The purpose of this study was to determine the association between the anatomical characteristics of neck and postoperative diaphragmatic paralysis in patients undergoing interscalene brachial plexus block before shoulder arthroscopic surgery.

NCT ID: NCT01429584 Completed - Diaphragm Paralysis Clinical Trials

The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function

Start date: May 2008
Phase: N/A
Study type: Interventional

Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.