Clinical trial NCT04946110: Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients
Official title: Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anaesthesia
Muscle Weakness
Keywords: VIDD
ICUAW
muscle weakness
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Stimit AG
First posted: 2021-06-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.

Detailed 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 leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* American Society of Anaesthesiologists Classification I or II

Exclusion Criteria:

* Chronic lung disease
* Preexisting diaphragmatic weakness
* Neurologic disease with known motor weakness
* Paralysis of the phrenic nerve
* Contraindication for any movement in the cervical vertebrae
* Conditions that limit the movement of the diaphragm e.g. ascites, increased intraabdominal pressure, adipositas.
* Inability to communicate in the official language
* Infections, lesions or stricture in the neck area
* Implanted cardiac devices e.g. pace maker, defibrillator, event recorder
* Implanted medical pumps e.g. left ventricular assist device
* Metal implants in the upper body
* Preganancy

Primary outcomes:
measure: Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
timeFrame: Study duration (approximately 10 minutes)
Secondary outcomes:
measure: Tidal volume per breath
timeFrame: Study duration (approximately 10 minutes)
measure: Max inspiratory flow after stimulation
timeFrame: Study duration (approximately 10 minutes)
measure: Abdominal extension maximum
timeFrame: Study duration (approximately 10 minutes)
measure: Air pressure during each breath
timeFrame: Study duration (approximately 10 minutes)
measure: Diaphragmatic thickening fraction
timeFrame: Study duration (approximately 10 minutes)
measure: Feedback/Stimulation locus relation
timeFrame: Study duration (approximately 10 minutes)
measure: Latency between stimulation and feedback
timeFrame: Study duration (approximately 10 minutes)
measure: Intensity/Contractility relation
timeFrame: Study duration (approximately 10 minutes)
measure: Time to find the optimal stimulation point of the N. phrenicus
timeFrame: Study duration (approximately 10 minutes)
measure: Distance between anatomical landmarks and optimal stimulation locus
timeFrame: Study duration (approximately 10 minutes)
measure: Reproducibility of stimulation answer
timeFrame: Study duration (approximately 10 minutes)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Study duration (approximately 10 minutes)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Univiversitätsmedizin Berlin
Study officials:
affiliation: Charité - Universitätsmedizin Berlin, Berlin, Germany
name: Stefan J Schaller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: