Electromagnetic Stimulation of the Phrenic Nerve in Critically Ill Mechanically Ventilated Patients (STIMIT-II) — STIMIT-II  

Critical Illness Clinical Trial

Official title: Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Critically Ill Mechanically Ventilated Patients - a Proof-of-concept Study (STIMIT-II)

Status Terminated

Clinical Trial Summary

Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive way to stimulate the diaphragm would be the electromagnetic stimulation but it is currently unclear if that is feasible.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging.

Clinical Trial Description

During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). The damage to the diaphragm in terms of muscle atrophy has been shown as early as 12 hours after initiation of mechanical ventilation. Recently, a correlation between diaphragmatic atrophy and mortality could be established.

Induction of diaphragmatic contractions via stimulation of the phrenic nerve would be a possible method to prevent or treat VIDD. A possible modality would be the non-invasive electromagnetic stimulation but feasibility has not been established.

In this proof-of-concept trial the primary aim is to show that it is possible to induce a diaphragmatic contraction in critically ill ICU patients via an external electromagnetic stimulation of the phrenic nerve, leading to an inspiration (i) with a sufficient tidal volume (3-6 ml/kg ideal body weight) and (ii) with verifiable muscular diaphragmatic contraction through ultrasound imaging. ;

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Complication
• Muscle Weakness
• Paresis

• NCT number: NCT05238753
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Terminated
• Phase: N/A
• Start date: January 21, 2022
• Completion date: May 15, 2022