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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04946110
Other study ID # STIMIT-I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 13, 2021
Est. completion date July 29, 2021

Study information

Verified date October 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
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 leading to an inspiration with a sufficient tidal volume via an external electromagnetic stimulation of the phrenic nerve.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date July 29, 2021
Est. primary completion date July 29, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electromagnetic stimulation
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 Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) Mean tidal volume of 10 consecutively stimulations of the phrenic nerve Study duration (approximately 10 minutes)
Secondary Tidal volume per breath Tidal volume Study duration (approximately 10 minutes)
Secondary Max inspiratory flow after stimulation The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second) Study duration (approximately 10 minutes)
Secondary Abdominal extension maximum Extension of the abdomen measured via in abdominal belt Study duration (approximately 10 minutes)
Secondary Air pressure during each breath Change in pressure in the duct from expiration to inspiration (mbar) Study duration (approximately 10 minutes)
Secondary Diaphragmatic thickening fraction Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation Study duration (approximately 10 minutes)
Secondary Feedback/Stimulation locus relation When the stimulation locus is changed according to protocol the change of the triggered breath is measured in % to the original location. Study duration (approximately 10 minutes)
Secondary Latency between stimulation and feedback Time between start and end of the stimulation in seconds Study duration (approximately 10 minutes)
Secondary Intensity/Contractility relation Correlation between the simulation intensity and the diaphragmatic contractility Study duration (approximately 10 minutes)
Secondary 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 (approximately 10 minutes)
Secondary Distance between anatomical landmarks and optimal stimulation locus Distance between anatomical landmarks and optimal stimulation locus Study duration (approximately 10 minutes)
Secondary Reproducibility of stimulation answer Variation of stimulated tidal volumes and diaphragm contraction Study duration (approximately 10 minutes)
Secondary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse Events elicited by the electromagnetic stimulation Study duration (approximately 10 minutes)
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