Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06339632
Other study ID # AVAP-NG 3363
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date March 1, 2025

Study information

Verified date March 2024
Source Hospital Sirio-Libanes
Contact RENATO F RIGHETTI, PhD
Phone 11987496664
Email refragar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Transcutaneous electrical phrenic nerve stimulation (TEPNS) and transcutaneous electrical diaphragm stimulation (TEDS) are modalities that use surface electrodes placed on the patients' skin to generate action potentials and contractions of the muscle fibers of the diaphragm. The primary objective will be to evaluate the efficacy of TEPNS and TEDS in healthy adult individuals. Secondary objectives will be to assess the feasibility, safety, and level of discomfort reported by the individual resulting from the application of TEPNS and TEDS.


Description:

This crossover trial, single-blind, bicentric study will be conducted at two hospitals. Adult volunteers aged 18 to 60 years, healthy, with a body mass index between 18.5 and 24.9 kg/m2, without a history of previous respiratory diseases, and without contraindications to undergo evaluation or application of the proposed electrical stimulation modalities will be included. Participants' diaphragm muscle will be assessed using ultrasound for variables such as thickness, thickness fraction, and diaphragm mobility. Patients will be randomized using opaque envelope draw prior to evaluation into two distinct experimental moments: 1) "TEPNS" moment - application of the TEPNS protocol; or 2) "TEDS" moment - application of the TEDS protocol. Additionally, data regarding the feasibility and safety of the application of electrical stimulation modalities will be collected.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date March 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age between 18 and 60 years; - Normal pulmonary function test, without alterations, assessed through spirometry; - Body Mass Index (BMI) between 18.5 and 24.9 kg/m2. Exclusion Criteria: - Smokers or former smokers; - Individuals with previously known cardiopulmonary diseases (restrictive lung diseases, chronic obstructive pulmonary disease - COPD, asthma, cystic fibrosis, among other pathologies); - Presence of implanted electrical devices (pacemaker, implantable cardioverter-defibrillator, among others); - Individuals who have contraindications to undergo evaluation and/or application of transcutaneous electrical stimulation of the diaphragm muscle, such as: altered sensitivity, wounds at the site of application, deformities, among other conditions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transcutaneous electrical phrenic nerve stimulation (TEPNS)
The characteristics of the electrical current: biphasic waves, set at a stimulation frequency of 10 Hz, pulse width of 200 µs, rise time of 1.0 second, on time of 1.0 second, fall time of 1.0 second, and off time of 2 seconds, resulting in 12 stimuli per minute. The application of "TEPNS" will initially be performed by defining the trajectory of the phrenic nerve in the cervical region. The negative pole (active point), a stick with a spherical tip for micro-current of 2 mm will be positioned with slight pressure in the region of the phrenic nerve pathway between the two heads of the sternocleidomastoid muscle. Additionally, at the positive pole (passive point), a self-adhesive electrode sized (2.0 x 2.0 cm) will be positioned on the skin in the shoulder region. The intensity, measured in milliamperes (mA), will be adjusted to the maximum tolerated by the patient. The total stimulation time will be 10 minutes, applied continuously in a single session.
Transcutaneous electrical diaphragm stimulation (TEDS)
The characteristics of the electrical current are: biphasic waves, set at a stimulation frequency of 30 Hz, pulse width of 400 µs, rise time of 1.0 second, on time of 1.0 second, fall time of 1.0 second, and off time of 2 seconds, resulting in 12 stimuli per minute. Two self-adhesive electrodes sized (5.0 x 5.0 cm) will be used, positioned in the bilateral parasternal region next to the xiphoid process and the other electrode in the intercostal space between the 6th and 7th ribs bilaterally, at the mid-axillary line. The intensity, measured in milliamperes (mA), will be adjusted to the maximum intensity tolerated by the patient until diaphragmatic contraction is observed with the naked eye, without contraction of other muscles in the abdominal region. The total stimulation time will be 10 minutes, applied continuously in a single session.

Locations

Country Name City State
Brazil Hospital Sírio Libanês São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Hospital Sirio-Libanes Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Boon AJ, Harper CJ, Ghahfarokhi LS, Strommen JA, Watson JC, Sorenson EJ. Two-dimensional ultrasound imaging of the diaphragm: quantitative values in normal subjects. Muscle Nerve. 2013 Jun;47(6):884-9. doi: 10.1002/mus.23702. Epub 2013 Apr 29. — View Citation

Cancelliero-Gaiad KM, Ike D, Pantoni CB, Mendes RG, Borghi-Silva A, Costa D. Acute effects of transcutaneous electrical diaphragmatic stimulation on respiratory pattern in COPD patients: cross-sectional and comparative clinical trial. Braz J Phys Ther. 2013 Nov-Dec;17(6):547-55. doi: 10.1590/S1413-35552012005000121. Epub 2013 Nov 14. — View Citation

Canella C, Demondion X, Delebarre A, Moraux A, Cotten H, Cotten A. Anatomical study of phrenic nerve using ultrasound. Eur Radiol. 2010 Mar;20(3):659-65. doi: 10.1007/s00330-009-1579-z. Epub 2009 Sep 2. — View Citation

Carrillo-Esper R, Perez-Calatayud AA, Arch-Tirado E, Diaz-Carrillo MA, Garrido-Aguirre E, Tapia-Velazco R, Pena-Perez CA, Espinoza-de Los Monteros I, Meza-Marquez JM, Flores-Rivera OI, Zepeda-Mendoza AD, de la Torre-Leon T. Standardization of Sonographic Diaphragm Thickness Evaluations in Healthy Volunteers. Respir Care. 2016 Jul;61(7):920-4. doi: 10.4187/respcare.03999. Epub 2016 Apr 12. — View Citation

Hedenstierna G, Tokics L, Lundquist H, Andersson T, Strandberg A, Brismar B. Phrenic nerve stimulation during halothane anesthesia. Effects of atelectasis. Anesthesiology. 1994 Apr;80(4):751-60. doi: 10.1097/00000542-199404000-00006. — View Citation

Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020. — View Citation

Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diaphragm mobility The assessment of diaphragmatic mobility will use a "convex" type transducer (2-6 MHz), positioned in the right subcostal space, at the midclavicular line, tilted in the cephalic direction. The B-mode visualization window will initially be used to locate the diaphragmatic hemi-dome. Upon acquiring a good quality image, respiratory excursions will be measured in M-mode, using the inferior vena cava and the gallbladder as anatomical parameters. Diaphragmatic mobility measurement will be considered as the distance, in centimeters, between the baseline at expiration and its greatest vertical displacement at inspiration produced by diaphragmatic movement. At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation.
Primary Diaphragm thickness Diaphragm thickness (Tdi) will be obtained using a high-frequency "linear" type transducer (7-13 MHz), positioned over the zone of apposition (ZA) of the diaphragm muscle. The approximate location is between the 8th and 9th intercostal space, between the anterior axillary line and the midaxillary line, 0.5 to 2.0 cm below the costophrenic angle. The depth will be 1.5 to 3.0 cm, and the diaphragm muscle will be identified as the innermost portion of the hypoechoic muscular layer bounded by two hyperechoic membranes, the pleura - superficial line, and the peritoneum - deeper line. "Tdi" will be measured from the inner edge of the pleural line to the inner edge of the peritoneal line at the end of expiration (Tdi-exp); and at the end of inspiration (Tdi-insp). At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation.
Primary Thickening fraction The thickening fraction will be obtained using a high-frequency "linear" type transducer (7-13 MHz), positioned over the zone of apposition (ZA) of the diaphragm muscle. The approximate location is between the 8th and 9th intercostal space, between the anterior axillary line and the midaxillary line, 0.5 to 2.0 cm below the costophrenic angle. The depth will be 1.5 to 3.0 cm, and the diaphragm muscle will be identified as the innermost portion of the hypoechoic muscular layer bounded by two hyperechoic membranes, the pleura - superficial line, and the peritoneum - deeper line. The localization of structures and measurements will be performed in B-mode. The diaphragm thickening fraction will be calculated as the percentage of thickness increment during inspiration relative to the thickness at the end of expiration. At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation.
Secondary Evaluation of sensory discomfort The assessment of reported sensory discomfort will be measured through the application of the horizontal numerical scale of sensory discomfort. The numerical scale will be presented to participants in its printed version, on standardized paper measuring 10 centimeters in length. The value "0" (zero) will be assigned to the concept of "absence of discomfort," and the value "10" (ten) will be assigned to the concept of "greatest imaginable discomfort." At baseline, five and 10 minutes the start of stimulation.
Secondary Safety of TEPNS and TEDS application Safety criteria will be measured through the occurrence of the number of adverse events, including: Mean arterial pressure < 65 mmHg; heart rate > 140 bpm or < 50 bpm; arrhythmias occurrence; oxygen saturation dropping below 88%; temperature increase (above 37.7°C); presence of reported pain above 7 on the visual analog pain scale; presence of burns at the site where electrodes were placed for electrostimulation. The numbers of adverse events will be recorded, along with their classification according to the World Health Organization Patient Safety Document as follows: no harm, minor, moderate, severe, and death. The events will be monitored throughout the entire period of TEPNS and TEDS application.
See also
  Status Clinical Trial Phase
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Completed NCT02801058 - Ultrasound Evaluation of Changes in Diaphragm Induced by Osteopathic Manipulative Techniques N/A
Completed NCT03688724 - Perioperative Diaphragm Point of Care Ultrasound
Completed NCT04052230 - Evolution of Diaphragm Thickness Under Veno-arterial ECMO
Recruiting NCT03827538 - Endobronchial Valves Positioning Effects On Diaphragm Function In Patients With Lung Hyperinflation
Recruiting NCT05965830 - Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
Completed NCT06086769 - High Flow Oxygen Therapy Effect on Healthy Subjects N/A
Completed NCT03129386 - Defining the Normal Range for Maximal Sniff Diaphragm Thickening Fraction
Completed NCT05670327 - Diaphragmatic Ultrasound and Weaning After Lung Transplant.
Recruiting NCT06009731 - Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial
Recruiting NCT01053182 - Esophagectomy Associated Respiratory Complications: Ivor-Lewis Versus Sweet Approaches Phase 3
Completed NCT04333186 - Expiratory Muscle Function in Critically Ill Ventilated Patients
Recruiting NCT05529641 - Effects of Diaphragmatic Resistance Training in People With Chronic Neck Pain. N/A
Completed NCT06347549 - The Impact of Diaphragmatic Breathing Instructions and Inspiratory Pressures on Diaphragm Contraction in Healthy Adults
Completed NCT02725190 - Effects of Sleep Deprivation on Diaphragm Command During an Inspiratory Endurance Trial in Healthy Volunteers. N/A
Recruiting NCT03114384 - Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography N/A
Not yet recruiting NCT06348745 - Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma. N/A