Association of Maximal Inspiratory Pressure and Weaning in Patients Undergoing Diaphragm Pacing
Back to course
Asset Caption
INTRODUCTION: The relative effects of transvenous diaphragm neurostimulation (TTDN) on the association of Maximal Inspiratory Pressure (MIP) with weaning and duration of mechanical ventilation (MV) in difficult-to-wean patients have not been reported.
METHODS: We conducted a multicenter, open label, randomized controlled trial of TTDN using a multi-electrode stimulating central venous catheter (Lungpacer Diaphragm Pacing Therapy System) in patients on MV for >96 hours with at least two failed spontaneous breathing trials and satisfying readiness to wean criteria. A total of 98 subjects were randomized (1:1) to TTDN (up to 120 stimulations per day; up to 30 days) or standard of care (SoC) in the modified intent to treat population. Clinical outcomes of the proportion of patients successfully weaned and MV duration were assessed in patients categorized by the median baseline absolute MIP into two cohorts – LowMIP (≤30 cmH2O, Nf49) or HighMIP ( >30 cmH2O, Nf49).
RESULTS: TTDN patients had a poorer average baseline MIP than the SoC patients (25.2 ±12 TTDN vs 32.8 ±14 SoC, p=0.005) resulting in more TTDN subjects in the LowMIP (28/49, 57%) than the HighMIP cohort (15/49, 31%). Weaning success was greater in the HighMIP vs the LowMIP cohort confirming the association with baseline MIP (p=0.007). There was a greater weaning success in the TTDN group compared to SoC, with the difference being more pronounced in the HighMIP cohort (HighMIP: 100% (TTDN) vs 81.8% (SoC), difference 18.2% (p=0.597); LowMIP: 72.7% (TTDN) vs 61.9% (SoC), difference 10.8% (p=0.335)).HighMIP subjects spent fewer days on MV than LowMIP subjects (11.15 vs 15.85 days). In either the HighMIP or LowMIP cohorts, the TTDN group spent fewer days on MV than the SoC group (HighMIP: 10.7 (TTDN) vs 11.3 (SoC) days, difference -0.6 days (p=0.827); LowMIP: 13.7 (TTDN) vs 18.6 (SoC) days, difference -4.8 days (p=0.335)), with the difference between groups being markedly better in the LowMIP cohort.
CONCLUSION: TTDN is feasible and safe in difficult to wean patients on MV. This analysis confirms the association of MIP with weaning success and days on MV. Moreover, TTDN appears to improve weaning success and reduce days on MV even in sicker patients with low baseline MIP.