Comparing Surgery and Non-Invasive Ventilation for Unilateral Diaphragm Paralysis in Adults

What this Trial Is About

Researchers are evaluating two treatment options for patients with unilateral diaphragm paralysis caused by phrenic nerve injury surgical diaphragm plication and nocturnal non-invasive ventilation NIV. This pilot study aims to determine the clinical effects of both therapies on quality of life, measured by the EQ-5D-5L questionnaire, and to understand the costs of each treatment from a societal perspective. The study is open-label and involves 20 participants aged 18 years and older. Participants will be divided into two groups, with 10 receiving surgical plication, a minimally invasive procedure to stiffen the diaphragm and reduce its abnormal movement, and 10 receiving nocturnal NIV while waiting for surgery. NIV supports breathing through a facial mask during sleep to improve sleep quality and reduce daytime symptoms. Both treatments are currently used in practice, but their comparative effects on patient outcomes and complications are not yet known. During the study, participants will be closely monitored through various assessments including the EQ-5D-5L quality of life questionnaire at baseline, 3 months, and 6 months, as well as tests like the Medical Research Council dyspnea scale, Diaphragmatic Paralysis Questionnaire, Borg dyspnea score, 6-minute walk test, spirometry in sitting and lying positions, polysomnography, and overnight carbon dioxide and oxygen saturation measurements. Safety monitoring will include follow-up calls and assessment of side effects related to both surgery and ventilation. The total study duration covers up to 15 months to capture outcomes and costs.

Diaphragm Paralysis: Surgery or Mechanical Ventialion