Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients

• Published in: American journal of respiratory and critical care medicine 2022-05, Vol.205 (10), p.1169-1178
• Main Authors: Dres, Martin, de Abreu, Marcelo Gama, Merdji, Hamid, Müller-Redetzky, Holger, Dellweg, Dominic, Randerath, Winfried J, Mortaza, Satar, Jung, Boris, Bruells, Christian, Moerer, Onnen, Scharffenberg, Martin, Jaber, Samir, Besset, Sébastien, Bitter, Thomas, Geise, Arnim, Heine, Alexander, Malfertheiner, Maximilian V, Kortgen, Andreas, Benzaquen, Jonathan, Nelson, Teresa, Uhrig, Alexander, Moenig, Olaf, Meziani, Ferhat, Demoule, Alexandre, Similowski, Thomas
• Format: Article
• Language: English
• Subjects: Aged; Clinical trials; Critical care; Diaphragm; Electric stimulation therapy; Extubation; Humans; Life Sciences; Life support systems; Lung diseases; Maximal Respiratory Pressures; Original; Pain; Patients; Phrenic Nerve; Respiration; Respiration, Artificial - adverse effects; Ventilator Weaning; Weaning
• ISSN: 1073-449X; 1535-4970
• DOI: 10.1164/rccm.202107-1709OC

Diaphragm dysfunction is frequently observed in critically ill patients with difficult weaning from mechanical ventilation. To evaluate the effects of temporary transvenous diaphragm neurostimulation on weaning outcome and maximal inspiratory pressure. Multicenter, open-label, randomized, controlled study. Patients aged ⩾18 years on invasive mechanical ventilation for ⩾4 days and having failed at least two weaning attempts received temporary transvenous diaphragm neurostimulation using a multielectrode stimulating central venous catheter (bilateral phrenic stimulation) and standard of care (treatment) (  = 57) or standard of care (control) (  = 55). In seven patients, the catheter could not be inserted, and in seven others, pacing therapy could not be delivered; consequently, data were available for 43 patients. The primary outcome was the proportion of patients successfully weaned. Other endpoints were mechanical ventilation duration, 30-day survival, maximal inspiratory pressure, diaphragm-thickening fraction, adverse events, and stimulation-related pain. The incidences of successful weaning were 82% (treatment) and 74% (control) (absolute difference [95% confidence interval (CI)], 7% [-10 to 25]),  = 0.59. Mechanical ventilation duration (mean ± SD) was 12.7 ± 9.9 days and 14.1 ± 10.8 days, respectively,  = 0.50; maximal inspiratory pressure increased by 16.6 cm H O and 4.8 cm H O, respectively (difference [95% CI], 11.8 [5 to 19]),  = 0.001; and right hemidiaphragm thickening fraction during unassisted spontaneous breathing was +17% and -14%, respectively,  = 0.006, without correlation with changes in maximal inspiratory pressure. Serious adverse event frequency was similar in both groups. Median stimulation-related pain in the treatment group was 0 (no pain). Temporary transvenous diaphragm neurostimulation did not increase the proportion of successful weaning from mechanical ventilation. It was associated with a significant increase in maximal inspiratory pressure, suggesting reversal of the course of diaphragm dysfunction. Clinical trial registered with www.clinicaltrials.gov (NCT03096639) and the European Database on Medical Devices (CIV-17-06-020004).