Effects of Transcutaneous Electrical Phrenic Nerve Stimulation and Transcutaneous Electrical Diaphragmatic Stimulation
- Conditions
- Diaphragm
- Interventions
- Other: Transcutaneous electrical diaphragm stimulation (TEDS)Other: Transcutaneous electrical phrenic nerve stimulation (TEPNS)
- Registration Number
- NCT06339632
- Lead Sponsor
- Hospital Sirio-Libanes
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Transcutaneous electrical diaphragm stimulation (TEDS) Transcutaneous electrical diaphragm stimulation (TEDS) The technique will be performed by applying transcutaneous neuromuscular electrical stimulation with the electrodes positioned bilaterally in the parasternal region adjacent to the xiphoid process, and the other electrode placed in the intercostal space. Transcutaneous electrical phrenic nerve stimulation (TEPNS) Transcutaneous electrical phrenic nerve stimulation (TEPNS) The technique will be performed by applying transcutaneous neuromuscular electrical stimulation to the phrenic nerve pathway in the cervical region.
- Primary Outcome Measures
Name Time Method Diaphragm thickness At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation. 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).
Thickening fraction At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation. 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.
Diaphragm mobility At baseline, between the fourth and fifth minutes and between the ninth and tenth minutes after the start of stimulation. 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.
- Secondary Outcome Measures
Name Time Method Safety of TEPNS and TEDS application The events will be monitored throughout the entire period 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.
Evaluation of sensory discomfort At baseline, five and 10 minutes the start of stimulation. 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."
Trial Locations
- Locations (1)
Hospital Sírio Libanês
🇧🇷São Paulo, Brazil