- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107167
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity (STIMIT-IA)
Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients With Obesity - a Proof-of-concept Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Charité - Univiversitätsmedizin Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electromagnetic stimulation
Electromagnetic stimulation of the phrenic nerve.
|
Electromagnetic stimulation of the phrenic nerve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1.Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
Time Frame: approximately 15 minutes
|
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
|
approximately 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Max inspiratory flow after stimulation
Time Frame: approximately 15 minutes
|
The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)
|
approximately 15 minutes
|
Abdominal extension maximum
Time Frame: approximately 15 minutes
|
Extension of the abdomen in centimeter measured via abdominal belt
|
approximately 15 minutes
|
Air pressure during each breath
Time Frame: approximately 15 minutes
|
Change in pressure in the duct from expiration to inspiration (mbar)
|
approximately 15 minutes
|
Diaphragmatic thickening fraction
Time Frame: approximately 15 minutes
|
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
|
approximately 15 minutes
|
Feedback/Stimulation locus relation
Time Frame: 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
|
approximately 15 minutes
|
Latency between stimulation and feedback
Time Frame: approximately 15 minutes
|
Time between start and end of the stimulation in seconds
|
approximately 15 minutes
|
Intensity/Contractility relation
Time Frame: approximately 15 minutes
|
Correlation between the simulation intensity and the diaphragmatic contractility
|
approximately 15 minutes
|
Time to find the optimal stimulation point of the N. phrenicus
Time Frame: approximately 15 minutes
|
Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
|
approximately 15 minutes
|
Distance between anatomical landmarks and optimal stimulation locus
Time Frame: approximately 15 minutes
|
Distance between anatomical landmarks and optimal stimulation locus
|
approximately 15 minutes
|
Reproducibility of stimulation answer
Time Frame: approximately 15 minutes
|
Variation of stimulated tidal volumes and diaphragm contraction using mean and standard deviation of each stimulation intensity
|
approximately 15 minutes
|
Incidence of Adverse Events during stimulation
Time Frame: approximately 15 minutes
|
Adverse Events elicited by the electromagnetic stimulation
|
approximately 15 minutes
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stefan J Schaller, Prof. Dr., Charité - Universitätsmedizin Berlin, Berlin, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STIMIT-IA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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