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

Primary Purpose

General Anaesthesia, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Electromagnetic stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Anaesthesia focused on measuring VIDD, ICUAW, muscle weakness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

1.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

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 in centimeter measured via 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 tidal volume 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 using mean and standard deviation of each stimulation intensity
Incidence of Adverse Events during stimulation
Adverse Events elicited by the electromagnetic stimulation

Full Information

First Posted
October 26, 2021
Last Updated
July 11, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
Stimit AG
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1. Study Identification

Unique Protocol Identification Number
NCT05107167
Brief Title
Electromagnetic Stimulation of the Phrenic Nerve of Intubated Patients With Obesity
Acronym
STIMIT-IA
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (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 in obese patients.
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

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
1.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
approximately 15 minutes
Secondary Outcome Measure Information:
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
approximately 15 minutes
Title
Abdominal extension maximum
Description
Extension of the abdomen in centimeter measured via abdominal belt
Time Frame
approximately 15 minutes
Title
Air pressure during each breath
Description
Change in pressure in the duct from expiration to inspiration (mbar)
Time Frame
approximately 15 minutes
Title
Diaphragmatic thickening fraction
Description
Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation
Time Frame
approximately 15 minutes
Title
Feedback/Stimulation locus relation
Description
When the stimulation locus is changed according to protocol the change of the triggered tidal volume is measured in % to the original location
Time Frame
approximately 15 minutes
Title
Latency between stimulation and feedback
Description
Time between start and end of the stimulation in seconds
Time Frame
approximately 15 minutes
Title
Intensity/Contractility relation
Description
Correlation between the simulation intensity and the diaphragmatic contractility
Time Frame
approximately 15 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
approximately 15 minutes
Title
Distance between anatomical landmarks and optimal stimulation locus
Description
Distance between anatomical landmarks and optimal stimulation locus
Time Frame
approximately 15 minutes
Title
Reproducibility of stimulation answer
Description
Variation of stimulated tidal volumes and diaphragm contraction using mean and standard deviation of each stimulation intensity
Time Frame
approximately 15 minutes
Title
Incidence of Adverse Events during stimulation
Description
Adverse Events elicited by the electromagnetic stimulation
Time Frame
approximately 15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 With Obesity

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