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Completed

NCT Number: NCT04946110

Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Univiversitätsmedizin Berlin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electromagnetic stimulation

Device

Electromagnetic stimulation of the phrenic nerve

Primary outcomes

  1. Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)

    Time frame: Study duration (approximately 10 minutes)

    Mean tidal volume of 10 consecutively stimulations of the phrenic nerve

Secondary outcomes

  1. Tidal volume per breath

    Time frame: Study duration (approximately 10 minutes)

    Tidal volume

  2. Max inspiratory flow after stimulation

    Time frame: Study duration (approximately 10 minutes)

    The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)

  3. Abdominal extension maximum

    Time frame: Study duration (approximately 10 minutes)

    Extension of the abdomen measured via in abdominal belt

  4. Air pressure during each breath

    Time frame: Study duration (approximately 10 minutes)

    Change in pressure in the duct from expiration to inspiration (mbar)

  5. Diaphragmatic thickening fraction

    Time frame: Study duration (approximately 10 minutes)

    Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation

  6. Feedback/Stimulation locus relation

    Time frame: Study duration (approximately 10 minutes)

    When the stimulation locus is changed according to protocol the change of the triggered breath is measured in % to the original location.

  7. Latency between stimulation and feedback

    Time frame: Study duration (approximately 10 minutes)

    Time between start and end of the stimulation in seconds

  8. Intensity/Contractility relation

    Time frame: Study duration (approximately 10 minutes)

    Correlation between the simulation intensity and the diaphragmatic contractility

  9. Time to find the optimal stimulation point of the N. phrenicus

    Time frame: Study duration (approximately 10 minutes)

    Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds

  10. Distance between anatomical landmarks and optimal stimulation locus

    Time frame: Study duration (approximately 10 minutes)

    Distance between anatomical landmarks and optimal stimulation locus

  11. Reproducibility of stimulation answer

    Time frame: Study duration (approximately 10 minutes)

    Variation of stimulated tidal volumes and diaphragm contraction

  12. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Study duration (approximately 10 minutes)

    Adverse Events elicited by the electromagnetic stimulation

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Stimit AG

Registry information

Official study title

Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study

Acronym: STIMIT-I

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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