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

Charité University Medicine Berlin

Status: Terminated

Conditions: Mechanical Ventilation Complication; Critical Illness; Muscle Weakness

Treatments: Device: Non-invasive electromagnetic stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05238753

STIMIT-II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18 and 60 years old, hospitalized in ICU
• Mechanical ventilation < 36 h
• Prone to stay ventilated > 72 h

Exclusion criteria

• Known neurological condition affecting motor neuron or muscle (e.g. ALS)
• Known paralysis of the phrenic nerve
• Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
• Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
• Not able to read and understand the national language German
• Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
• Patients with implanted medical pumps
• Pregnant patients
• Patients with skin lesions, infections or strictures in throat/neck area
• Patients with metallic implants

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Intervention, stimulated

Experimental group

Description:

Electromagnetic stimulation of the phrenic nerve in critically ill patients.

Treatment:

Device: Non-invasive electromagnetic stimulation

Control, not stimulated

No Intervention group

Description:

Control group, no stimulation of the phrenic nerve.