STIMIT-IA: Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT05107167
• Collaborator: Stimit AG (Industry)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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 in obese patients.

Condition or Disease	Intervention/Treatment	Phase
General Anaesthesia; Muscle Weakness	Device: Electromagnetic stimulation	N/A

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 in obese patients

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients With Obesity - a Proof-of-concept Study
• Actual Study Start Date: Dec 14, 2021
• Actual Primary Completion Date: Apr 25, 2022
• Actual Study Completion Date: Apr 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electromagnetic stimulation Electromagnetic stimulation of the phrenic nerve.	Device: Electromagnetic stimulation; Electromagnetic stimulation of the phrenic nerve

Outcome Measures

Primary Outcome Measures

1. 1.Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) [approximately 15 minutes]

   Mean tidal volume of 10 consecutively stimulations of the phrenic nerve

Secondary Outcome Measures

1. Max inspiratory flow after stimulation [approximately 15 minutes]

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

2. Abdominal extension maximum [approximately 15 minutes]

   Extension of the abdomen in centimeter measured via abdominal belt

3. Air pressure during each breath [approximately 15 minutes]

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

4. Diaphragmatic thickening fraction [approximately 15 minutes]

   Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation

5. Feedback/Stimulation locus relation [approximately 15 minutes]

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

6. Latency between stimulation and feedback [approximately 15 minutes]

   Time between start and end of the stimulation in seconds

7. Intensity/Contractility relation [approximately 15 minutes]

   Correlation between the simulation intensity and the diaphragmatic contractility

8. Time to find the optimal stimulation point of the N. phrenicus [approximately 15 minutes]

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

9. Distance between anatomical landmarks and optimal stimulation locus [approximately 15 minutes]

   Distance between anatomical landmarks and optimal stimulation locus

10. Reproducibility of stimulation answer [approximately 15 minutes]

    Variation of stimulated tidal volumes and diaphragm contraction using mean and standard deviation of each stimulation intensity

11. Incidence of Adverse Events during stimulation [approximately 15 minutes]

    Adverse Events elicited by the electromagnetic stimulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ≥ 18 years of age

• American Society of Anaesthesiologists Classification I or II

• Planned anesthesia with intubation

• Adipositas Grade II-III

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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - Univiversitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany
• Stimit AG

Investigators

• Principal Investigator: Stefan J Schaller, Prof. Dr., Charité - Universitätsmedizin Berlin, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefan J Schaller, Deputy Clinical Director, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT05107167
• Other Study ID Numbers: STIMIT-IA
• First Posted: Nov 4, 2021
• Last Update Posted: Jul 12, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefan J Schaller, Deputy Clinical Director, Charite University, Berlin, Germany: VIDD; ICUAW; muscle weakness
• Additional relevant MeSH terms: Muscle Weakness; Paresis

Study Results

No Results Posted as of Jul 12, 2022