Muscle Weakness Clinical Trial
— STIMIT-IAOfficial 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
Verified date | February 2022 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | April 25, 2022 |
Est. primary completion date | April 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Univiversitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Stimit AG |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1.Tidal volume generated by electromagentical stimulation of the phrenic nerve (ml) | Mean tidal volume of 10 consecutively stimulations of the phrenic nerve | approximately 15 minutes | |
Secondary | Max inspiratory flow after stimulation | The maximal air flow created in the duct following stimulation of the N. phrenicus (meter / second) | approximately 15 minutes | |
Secondary | Abdominal extension maximum | Extension of the abdomen in centimeter measured via abdominal belt | approximately 15 minutes | |
Secondary | Air pressure during each breath | Change in pressure in the duct from expiration to inspiration (mbar) | approximately 15 minutes | |
Secondary | Diaphragmatic thickening fraction | Diaphragmatic contractility measured by ultrasound after N. phrenicus stimulation | approximately 15 minutes | |
Secondary | 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 | approximately 15 minutes | |
Secondary | Latency between stimulation and feedback | Time between start and end of the stimulation in seconds | approximately 15 minutes | |
Secondary | Intensity/Contractility relation | Correlation between the simulation intensity and the diaphragmatic contractility | approximately 15 minutes | |
Secondary | 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 | approximately 15 minutes | |
Secondary | Distance between anatomical landmarks and optimal stimulation locus | Distance between anatomical landmarks and optimal stimulation locus | approximately 15 minutes | |
Secondary | Reproducibility of stimulation answer | Variation of stimulated tidal volumes and diaphragm contraction using mean and standard deviation of each stimulation intensity | approximately 15 minutes | |
Secondary | Incidence of Adverse Events during stimulation | Adverse Events elicited by the electromagnetic stimulation | approximately 15 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05543980 -
Leg Heat Therapy in Elderly Individuals
|
Phase 2 | |
Enrolling by invitation |
NCT03297632 -
Improving Muscle Strength, Mass and Physical Function in Older Adults
|
N/A | |
Completed |
NCT04207359 -
Effects of Creatine Supplementation in Breast Cancer Survivors
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT04076982 -
Effect of Supplementary Dietary Protein (21g Per Day) on Lean Mass and Strength in Sedentary, Adult Vegetarians
|
N/A | |
Not yet recruiting |
NCT03662555 -
Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function
|
N/A | |
Completed |
NCT02530723 -
Functional Changes and Power Training in Older Women.
|
N/A | |
Completed |
NCT01704976 -
SR-WBV Training for Frail Elderly in the Skilling up Stage
|
N/A | |
Completed |
NCT01743495 -
CAPABLE for Frail Dually Eligible Older Adults
|
N/A | |
Completed |
NCT00183040 -
HORMA: Hormonal Regulators of Muscle and Metabolism in Aging
|
Phase 2 | |
Enrolling by invitation |
NCT06432062 -
Investigation the Effect of Rectus Abdominis and Erector Spinae Muscle Fatigue on the Viscoelastic Properties of Thoracolumbal Fascia
|
||
Recruiting |
NCT05073224 -
Muscle Function After Childbirth
|
N/A | |
Completed |
NCT04956705 -
Vitamin D and Calcium Supplementation at Danish Nursing Homes
|
N/A | |
Recruiting |
NCT03810768 -
Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
|
||
Completed |
NCT00060970 -
Evaluating Muscle Function After Ankle Surgery
|
N/A | |
Completed |
NCT04546048 -
The Early Strength Training Program in Post-transplant Liver Cases
|
N/A | |
Completed |
NCT03628365 -
Can Beta-Hydroxy-beta-Methylbutyrate Supplementation Counteract Muscle Catabolism in Critically Ill Patients?
|
N/A | |
Completed |
NCT05056298 -
Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot
|
N/A | |
Completed |
NCT02739464 -
Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients
|
N/A | |
Completed |
NCT05497960 -
Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes
|
N/A |