Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients (STIMIT-I)
Primary Purpose
General Anaesthesia, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Electromagnetic stimulation
Sponsored by
About this trial
This is an interventional prevention trial for General Anaesthesia focused on measuring VIDD, ICUAW, muscle weakness
Eligibility Criteria
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
Sites / Locations
- Charité - Univiversitätsmedizin Berlin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electromagnetic stimulation
Arm Description
Electromagnetic stimulation of the phrenic nerve.
Outcomes
Primary Outcome Measures
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
Secondary Outcome Measures
Tidal volume per breath
Tidal volume
Max inspiratory flow after stimulation
The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)
Abdominal extension maximum
Extension of the abdomen measured via in abdominal belt
Air pressure during each breath
Change in pressure in the duct from expiration to inspiration (mbar)
Diaphragmatic thickening fraction
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
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.
Latency between stimulation and feedback
Time between start and end of the stimulation in seconds
Intensity/Contractility relation
Correlation between the simulation intensity and the diaphragmatic contractility
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
Distance between anatomical landmarks and optimal stimulation locus
Distance between anatomical landmarks and optimal stimulation locus
Reproducibility of stimulation answer
Variation of stimulated tidal volumes and diaphragm contraction
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events elicited by the electromagnetic stimulation
Full Information
NCT ID
NCT04946110
First Posted
March 17, 2021
Last Updated
October 26, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Stimit AG
1. Study Identification
Unique Protocol Identification Number
NCT04946110
Brief Title
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients
Acronym
STIMIT-I
Official Title
Electromagnetic Stimulation of the Phrenic Nerve to Generate Contraction of the Diaphragm in Anesthetized and Intubated Patients - a Proof-of-concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
July 29, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Stimit AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anaesthesia, Muscle Weakness
Keywords
VIDD, ICUAW, muscle weakness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic stimulation
Arm Type
Experimental
Arm Description
Electromagnetic stimulation of the phrenic nerve.
Intervention Type
Device
Intervention Name(s)
Electromagnetic stimulation
Intervention Description
Electromagnetic stimulation of the phrenic nerve
Primary Outcome Measure Information:
Title
Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml)
Description
Mean tidal volume of 10 consecutively stimulations of the phrenic nerve
Time Frame
Study duration (approximately 10 minutes)
Secondary Outcome Measure Information:
Title
Tidal volume per breath
Description
Tidal volume
Time Frame
Study duration (approximately 10 minutes)
Title
Max inspiratory flow after stimulation
Description
The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second)
Time Frame
Study duration (approximately 10 minutes)
Title
Abdominal extension maximum
Description
Extension of the abdomen measured via in abdominal belt
Time Frame
Study duration (approximately 10 minutes)
Title
Air pressure during each breath
Description
Change in pressure in the duct from expiration to inspiration (mbar)
Time Frame
Study duration (approximately 10 minutes)
Title
Diaphragmatic thickening fraction
Description
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
Time Frame
Study duration (approximately 10 minutes)
Title
Feedback/Stimulation locus relation
Description
When the stimulation locus is changed according to protocol the change of the triggered breath is measured in % to the original location.
Time Frame
Study duration (approximately 10 minutes)
Title
Latency between stimulation and feedback
Description
Time between start and end of the stimulation in seconds
Time Frame
Study duration (approximately 10 minutes)
Title
Intensity/Contractility relation
Description
Correlation between the simulation intensity and the diaphragmatic contractility
Time Frame
Study duration (approximately 10 minutes)
Title
Time to find the optimal stimulation point of the N. phrenicus
Description
Time between first successful N. phrenicus stimulation and identification of the optimal stimulation locus in seconds
Time Frame
Study duration (approximately 10 minutes)
Title
Distance between anatomical landmarks and optimal stimulation locus
Description
Distance between anatomical landmarks and optimal stimulation locus
Time Frame
Study duration (approximately 10 minutes)
Title
Reproducibility of stimulation answer
Description
Variation of stimulated tidal volumes and diaphragm contraction
Time Frame
Study duration (approximately 10 minutes)
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Adverse Events elicited by the electromagnetic stimulation
Time Frame
Study duration (approximately 10 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan J Schaller, Prof. Dr.
Organizational Affiliation
Charité - Universitätsmedizin Berlin, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Univiversitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data can be requested on reasonable scientific request.
IPD Sharing Time Frame
After publication of scientific manuscript.
IPD Sharing Access Criteria
Deidentified data can be requested on reasonable scientific request.
Learn more about this trial
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients
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