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

Critical Illness Clinical Trial

— STIMIT-II  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05238753
• Other study ID #: STIMIT-II
• Status: Terminated
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: May 15, 2022

Study information

• Verified date: September 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Non-invasive electromagnetic stimulation
Non-invasive bilateral electromagnetic stimulation of the phrenic nerve

Locations

Country	Name	City	State
Germany	Charité - Univiversitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Stimit AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of non-feasible stimulation, due to organisational or patient-specific reasons.	Percentage of non-feasible stimulation out of the total number of stimulations planned according to the investigation protocol.	10 days
Primary	Time to find the optimal stimulation point of the N. phrenicus	Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds	Study duration (10 days)
Primary	Frequency of sufficient Tidal volume generated by electromagentical stimulation of the phrenic nerve (3-6 ml/kg ideal body weight)	Percentage of stimulated breaths above the cut-off Today volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths. Tidal volumes are measured by the mechanical ventilator.	Study duration (10 days)
Secondary	Variance of Tidal volume generated by electromagentical stimulation of the phrenic nerve	Measurement of variance among the Tidal volumes stimulated during the experimental therapy intervention; Tidal volumes are measured by the mechanical ventilator.	Study duration (10 days)
Secondary	Correlation between amplitude and duration of sEMG signals during stimulated breathing.	sEMG amplitude and duration are measured by a device (sEMG Amplificator) connected to electrodes applied to the patient's chest during electromagnetic phrenic nerve stimulation.	Study duration (10 days)
Secondary	Transpulmonary pressure during electromagnetical stimulation of the phrenic nerve	Transpulmonary pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	Study duration (10 days)
Secondary	Occlusion pressure during electromagnetical stimulation of the phrenic nerve	Occlusion pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	Study duration (10 days)
Secondary	Diaphragm thickening fraction	Diaphragm thickening fraction measured with ultrasound of the diaphragm.	approx. 28 days (till ICU discharge)
Secondary	Diaphragm excursion	Diaphragm excursion measured with ultrasound of the diaphragm.	approx. 28 days (till ICU discharge)
Secondary	Stimulated tracheal pressure during electromagentical stimulation of the phrenic nerve	Stimulated tracheal pressure is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	Study duration (10 days)
Secondary	Rapid Shallow Breathing Index (RSBI) record and evaluation.	Progression of RSBI during 10 days after subject inclusion, based on the mechanical ventilation parameters (Tidal volume) and the ICU continuous monitoring system (Respiratory Rate).	Study duration (10 days)
Secondary	Lung compliance during electromagentical stimulation of the phrenic nerve	Lung compliance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	10 days
Secondary	Lung resistance during electromagentical stimulation of the phrenic nerve	Lung resistance is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	10 days
Secondary	Maximal inspiratory pressure (MIP) during electromagnetical stimulation of the phrenic nerve.	MIP is measured by the mechanical ventilator during electromagnetic phrenic nerve stimulation.	Study duration (10 days)
Secondary	Expiratory and Inspiratory Diaphragm Thickness measured by Ultrasound	Diaphragm Thickness measured by Ultrasound as a baseline parameter for muscle atrophy.	Study duration (10 days)