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

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Electrical Stimulation for Slow Breathing?

Transcutaneous electrical stimulation has been shown to improve chest expansion and mobility in patients after thoracotomy surgery, which suggests it might help with breathing issues. Additionally, electrical stimulation has been used successfully to restore breathing in patients with severe respiratory problems, indicating potential benefits for slow breathing. ^{1 2 3 4 5}

Is transcutaneous electrical stimulation generally safe for humans?

Transcutaneous electrical stimulation, including its use in various forms like transcranial direct current stimulation (tDCS), is generally considered safe for humans. Over 18,000 sessions have shown no serious adverse events, with only mild issues like headaches or skin sensations reported, and these are similar in both healthy and clinical populations. ^{3 6 7 8 9}

How does transcutaneous electrical stimulation differ from other treatments for slow breathing?

Transcutaneous electrical stimulation is unique because it is a non-invasive treatment that uses electrical currents applied through the skin to stimulate muscles, unlike other treatments that may involve medication or invasive procedures. This method is often used in other conditions like obstructive sleep apnea, where it aims to improve muscle function without the need for surgery or drugs. ^{9 10 11 12 13}

What is the purpose of this trial?

After surgery, patients often recover in a special area called the Post Anesthesia Care Unit (PACU). Patients may receive pain medications either during the surgery or afterward in the PACU. While these medications are important for controlling pain, some of them can slow down breathing. To ensure patients' breathing remains safe, the nurses in the PACU monitor respiratory rate (how many breaths a patient takes per minute) and oxygen levels using standard monitoring equipment. This is the usual way they check for breathing concerns. If these monitors show that a patient's breathing has slowed down too much, nurses may wake the patient up or stimulate them using their voice or gentle physical touch to encourage deeper breaths. What is this study about? This research is testing a new approach that uses an additional monitor called capnography. Capnography helps detect slowing or stopping of breathing by measuring the carbon dioxide (CO2) exhaled by patients. If the monitor shows slowed or stopped breathing (called apnea, lasting at least 10 seconds), this study will test using a technology called transcutaneous electrical stimulation (TES) to encourage normal breathing. How does TES work? TES provides a slight, annoying sensation on the patient's skin-enough to wake them up without causing pain. This has been used in other studies to safely restore breathing after surgery. In this study, the researchers are testing whether a new automated device can deliver TES when the capnography monitor detects breathing issues. The goal is to test the feasibility (can this system work in the PACU?) and acceptability (how do patients feel about this approach?) of this technology. Who can join this study? Adults aged 18 or older who received general anesthesia and medications (opioids) for pain control during or after surgery are eligible. Patients recovering from surgery in the PACU at Toronto General Hospital may be invited to participate. Why is this study important? The study aims to reduce the risk of opioid-related breathing problems after surgery, making recovery safer and more comfortable for patients.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Feasibility of transcutaneous electrical muscle stimulation in acute exacerbation of COPD. [2021]

2. Brazil pubmed.ncbi.nlm.nih.gov

Short-duration transcutaneous electrical nerve stimulation in the postoperative period of cardiac surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation to restore respiration. [2007]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of chest wall transcutaneous electrical nerve stimulation on dyspnoea. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Postoperative thoracotomy. Effect of transcutaneous electrical nerve stimulation on forced vital capacity. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety evaluation of a new setup for transcranial electric stimulation during magnetic resonance imaging. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Electrodes for high-definition transcutaneous DC stimulation for applications in drug delivery and electrotherapy, including tDCS. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The effect of electrical stimulation on obstructive sleep apnea syndrome. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

[Submental transcutaneous electrical stimulation for obstructive sleep apnea]. [2018]

13. China pubmed.ncbi.nlm.nih.gov

[The effects of transcutaneous electrical stimulation during sleep on obstructive sleep apnea]. [2006]