Diaphragm paralysis: surgery or non-invasive ventilation?

surgery Non-invasive ventilation Diaphragm paralysis

Prof. dr. M.L. Duiverman
Prof. dr. P.J. Wijkstra

Nature of the research:
Randomised controlled trial

Fields of study:
surgery pulmonology intensive care

Background / introduction
The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. It is the most important muscle of respiration innervated by the phrenic nerves.
While many diseases might interfere with its function (1), in the intended study we will focus on diaphragm paralysis due to phrenic nerve damage. Two types of diaphragm paralysis can be distinguished: unilateral and bilateral. Patients with unilateral paralysis perceive exertional dyspnoea, have an impaired exercise capacity and orthopnoea.(2) Patients with a bilateral paralysis normally have more symptoms and might even develop respiratory failure. (3) In
addition, all patients with a diaphragm paralysis may have poor sleep quality, as diaphragm is
the only active respiratory muscle during REM sleep. (4) Currently, two treatment approaches for
patients with diaphragm paralysis are used in clinical practice: diaphragm plication and nocturnal
non-invasive mechanical ventilation (NIV). Plication is a minimal invasive surgical procedure that aims to stiffen the diaphragm and such limits dysfunctional excursions of the paralytic diaphragm. The procedure is performed in ±70 patients per year in the Netherlands. NIV is a non-invasive mode of positive pressure ventilatory assistance; through a facial mask the ventilator supports
patient breathing effort. Patients with diaphragm paralysis use their ventilator mainly during night
time, to improve quality of sleep and such to reduce day time symptoms. In the Netherlands, home mechanical ventilation is very well organized, as care is delivered by only 4 specialized centres. NIV for diaphragm paralysis is started in around 50 patients yearly.
Research question / problem definition
Primary question: Is diaphragm plication or chronic nocturnal NIV the most cost-effective treatment option for patients with a unilateral- or bilateral diaphragm paralysis?
Explorative question: Which clinical characteristics predict the success of either surgical plication or non-invasive ventilation ?
Depending on the time period available the student can have the following tasks:
- a retrospective analysis of all patients with a diaphragm paralysis that have been treated with chronic non-invasive ventilatory support by the home mechanical ventilation center Groningen or (with more availibilty) of all diaphragm paralysis patients in the Netherlands and/or all patients that underwent a diaphragm plication.
- the student will assist or (with more availability) be coordinating investigator of the prospective randomised controlled pilot trial as described above. In total, for this pilot 20 patients will be randomised for NIV or plication. the student will learn to perform study procedures (like exercise tests, questionnaires, diaphram ultrasound), will coordinate the study flow and be co-author in the publication of the results.
1. McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012;366(10):932-42.
2. van Alfen N, Doorduin J, van Rosmalen MHJ, van Eijk JJJ, Heijdra Y, Boon AJ, Gaytant MA,
van den Biggelaar RJM, Sprooten RTM, Wijkstra PJ, Groothuis JT. Phrenic neuropathy and
diaphragm dysfunction in neuralgic amyotrophy. Neurology. 2018;91(9):e843-e9.
3. Hart N, Nickol AH, Cramer D, et al Effect of severe isolated unilateral and bilateral diaphragm
weakness on exercise performance. Am J Respir Crit Care Med. 2002;165(9):1265-70.
4. Steier J, Jolley CJ, Seymour J, et al . Sleep-disordered breathing in unilateral diaphragm
paralysis or severe weakness. Eur Respir J. 2008;32(6):1479-87.
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