STIMULUS: A randomized clinical trial of diaphragm pacing in patients on life support for breathing failure
Study Status: Completed
Study Purpose: This study assessed the use of gentle electrical pulses to temporarily stimulate the diaphragm muscle to contract in patients on a breathing machine. The gentle electrical pulses were delivered through a special catheter.
Background: Mechanical ventilation (the 'breathing machine') and sedation are common life-saving methods used to help patients with breathing problems, especially those with lung failure. However, these treatments suppress the patient’s natural breathing rhythm and stop the diaphragm (the main breathing muscle) from contracting. When the diaphragm stops contracting, several problems may rapidly develop. These include diaphragm muscle weakness, poor blood circulation, lung deflation and lung injury. These problems can slow down a patient’s recovery and prolong their need to stay on the “breathing machine”. This also increases their risk of death or long-term disability.
Study Methods: For our study, we equipped 19 patients on mechanical ventilation with a special catheter. The catheter had electrodes that connected directly to the phrenic nerve. Through this catheter, gentle electrical pulses were delivered to the phrenic nerve, to cause the diaphragm muscle to contract in sync with the ventilator.
Key Findings: This was a first in-human trial of this strategy. The diaphragm was successfully stimulated and all patients were kept artificially breathing for as long as they were on the ventilator. Overall, the study procedure was considered safe.
The ability to temporarily stimulate the phrenic nerve to keep the diaphragm contracting is a promising strategy. It has the potential to reduce the negative effects of mechanical ventilation on the diaphragm, lungs, and circulation. Studying this for the first time in humans, will lead to future research to test the benefit of this strategy for survival, recovery, and quality of life.
Health Conditions: Lungs & Breathing conditions