Transcutaneous Electrical Stimulation for Slow Breathing

(TESCapno Trial)

Overseen By Mohammad Goudarzi-Rad, PhD Candidate

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Opioids

Disqualifiers: Implantable devices, Epilepsy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to an hour after PACU admission

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to make breathing safer for patients after surgery. A device provides a gentle electrical nudge if the patient's breathing slows excessively, encouraging deeper breaths. Known as Transcutaneous Electrical Stimulation, this method aims to evaluate its effectiveness and gather patient feedback. Adults who have undergone surgery with general anesthesia and pain medication may be suitable participants, especially if recovering at Toronto General Hospital. The goal is to reduce breathing issues linked to pain medications, making recovery smoother and safer. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance post-surgical recovery for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves monitoring breathing after surgery, it's important to discuss your medications with the study team to ensure they don't interfere with the trial.

What prior data suggests that this transcutaneous electrical stimulation is safe for patients recovering from surgery?

Research has shown that transcutaneous electrical stimulation (TES) is generally safe and well-tolerated. For example, a study involving individuals with chronic obstructive pulmonary disease found TES to be safe and caused minimal discomfort. Participants did not report any serious side effects.

In another study, patients using TES experienced positive results, with more than a third showing improved symptoms. Although this study examined different conditions, it suggests that TES is unlikely to cause harm.

Specific safety data for the exact TES device used in this study is not available, but TES technology has been safely applied in many other medical contexts. Therefore, it is reasonable to expect it to be safe in this study as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Stimulation (TES) for slow breathing because it offers a unique approach by using mild electrical pulses to prompt breathing after detecting an apnea episode. Unlike traditional treatments that might involve medications or mechanical ventilation, TES is non-invasive and directly stimulates the body's natural breathing reflexes. This method could provide a quicker response to apnea episodes, enhancing patient safety and comfort without the need for more intrusive interventions. By continuously monitoring end-tidal carbon dioxide (ETCO2) levels, TES can deliver timely stimulation to help maintain normal breathing patterns, offering a promising new avenue for managing slow breathing.

What evidence suggests that transcutaneous electrical stimulation is effective for encouraging normal breathing after surgery?

This trial will compare Transcutaneous Electrical Stimulation (TES) with a placebo (Monitor-Only mode) to assess its effectiveness in addressing slow breathing. Research has shown that TES can help with breathing problems by improving chest movement and lung function in patients after certain surgeries. This suggests it might aid in breathing recovery when opioids slow it down. In studies on sleep disorders, TES has also helped keep airways open and improved oxygen levels. Although direct data on using TES for breathing after surgery is limited, these findings suggest it could help restore normal breathing. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are recovering from elective surgery with general anesthesia at Toronto General Hospital. They must be able to understand and consent to the study, complete questionnaires, and have an ASA grade I-IV.

Inclusion Criteria

I can fill out questionnaires by myself or with help.

I understand what participating in this study involves.

I can sign and understand the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to an hour after PACU admission

Treatment

Participants are monitored using capnography and receive transcutaneous electrical stimulation (TES) if apnea is detected

Up to an hour after PACU admission

Continuous monitoring during PACU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to an hour after PACU admission

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Stimulation

Trial Overview

The study tests a new system that uses transcutaneous electrical stimulation (TES) when capnography detects breathing issues in patients post-surgery. It aims to see if this automated device can safely encourage normal breathing in the PACU.

How Is the Trial Designed?

Group I: Transcutaneous Electrical Stimulation (TES) Experimental Treatment 1 Intervention

All patients assigned to the intervention group will be continuously monitored by capnography, which is attached to the TES device. This monitoring will continuously track end-tidal carbon dioxide (ETCO2) levels. A mild electrical stimulation will be initiated when the episode of apnea ≥10 seconds is detected by the capnography. Patients in the intervention group will receive TES applied to the ventral surface of the forearm via electrodes in response to the apnea lasting for more than or equal to 10 seconds. When apnea persists for more than or equal 10 seconds, a pre-determined, patient-specific mA current stimulus will be administered for one second. If the patient has not taken a breath after the first stimulation, a second stimulus of similar intensity will be administered for three seconds. Subsequently, all stimuli will be administered for three seconds until the apnea criteria have ceased.

Group II: Placebo (Monitor-Only mode) Active Control 1 Intervention

The control group will be monitored by capnography attached to the TES device. The TES electrode will be placed on the ventral surface of the wrist, but no stimulus will be applied (Monitor-Only mode). Participants in the control group will be checked during the PACU stay to make sure that they are still comfortable, and any adverse events will be documented.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Transcranial electrical stimulation (tES), including tDCS and MHF-tPCS, was found to be well tolerated in healthy subjects over a six-week period, with common side effects being mild skin sensations like tingling and itching, which were less frequent than in the sham-tDCS group.

The MHF-tPCS group showed significantly higher compliance in completing sessions compared to the sham-tDCS group, indicating that this waveform may be more acceptable for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. Paneri, B., Adair, D., Thomas, C., et al.[2018]

Transcutaneous electrical muscle stimulation (TEMS) was found to be safe and well-tolerated in 19 patients with acute exacerbations of chronic obstructive pulmonary disease (COPD), who participated in an average of 15 training sessions during hospitalization.

The study suggests that TEMS could be a promising intervention for COPD patients, paving the way for future research to explore its specific benefits when combined with other treatments like nutrition and medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of transcutaneous electrical muscle stimulation in acute exacerbation of COPD. Meglic, U., Sorli, J., Kosnik, M., et al.[2021]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

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Transcutaneous Electrical Stimulation for Slow Breathing

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Electrical Stimulation Treatment for OSA Supported by Low ...

The trial, which involved 46 participants showed that HNS increased the mean (SD) AHI from 7.4 (6.1) to 25.5 (15.2) events/hour and that AHI ...