Using electrical stimulation to improve breathing after surgery
Feasibility and Acceptability of Transcutaneous Electrical Stimulation for Apnea Detected by Capnography (TESCapno): A Pilot Randomized Controlled Trial
NA · University of Toronto · NCT06823661
This study is testing whether using electrical stimulation can help patients breathe better after surgery when they are recovering in the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Toronto (other) |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT06823661 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of transcutaneous electrical nerve stimulation (TENS) in patients recovering from elective surgeries in the Post Anesthesia Care Unit (PACU). The study employs capnography to monitor carbon dioxide levels in exhaled breath, allowing for early detection of respiratory depression caused by pain medications. If breathing slows, TENS will be applied to stimulate deeper breaths, potentially enhancing patient recovery and safety. The goal is to assess the effectiveness of this approach compared to standard monitoring methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective surgeries with general anesthesia who are recovering in the PACU.
Not a fit: Patients with severe preoperative conditions (ASA grade V-VI) or those undergoing urgent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve respiratory function and safety in patients recovering from surgery.
How similar studies have performed: While the use of TENS for respiratory issues is a novel approach, similar studies have shown promise in improving patient outcomes in related areas.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females at least 18 years old * Adults undergoing an elective (General, Plastics, Urology, Gynecologic Oncology, Vascular, Otolaryngology, Transplant) surgery with general anesthesia who are recovering in the PACU * American Society of Anesthesiologists (ASA) grade I-IV * Scheduled to be seen at the Pre-Admission Clinic or Surgery Inpatient Unit * Able to complete questionnaires with or without assistance * Able to understand the study protocol, its requirements, risks, and discomforts * Able to provide written informed consent Exclusion Criteria: * A) Preoperative exclusion criteria: * American Society of Anesthesiologists (ASA) grade V-VI * Urgent or emergent surgical procedures that there is insufficient time prior to anticipated commencement of the procedure for participation in the study * Patients with implantable medical electronic devices (eg, pacemaker, implantable cardioverter defibrillator, catheter, and so on.) * Patients with febrile illnesses or acute infectious diseases * Pregnancy * Epilepsy. * B) Postoperative exclusion criteria: * Surgery that would preclude the use of a nasal cannula or face mask used for capnography monitoring (e.g., facial reconstruction) * Postoperative mental status precludes application of study equipment, including a nasal cannula/face mask and/or the stimulation pads (e.g., delirium or agitation during recovering from anesthesia, repeated removal of cannula) * Postoperative admission to the ICU or any site other than the PACU * Need for postoperative assisted ventilation via an endotracheal tube or tracheostomy * An abnormal respiratory tract identified during or immediately after surgery can lead to severe respiratory obstruction * Patients with cardiac arrhythmia (history of atrial fibrillation or bundle branch block) * Skin conditions such as open sores preventing proper application of electrodes * Presence of metal implants in both arms * Lack of access to upper extremities following surgery for application of the stimulation pads
Where this trial is running
Toronto, Ontario and 1 other locations
- Toronto General Hospital — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
- Toronto General Hospital — Toronto, Canada (RECRUITING)
Study contacts
- Study coordinator: Mohammad Goudarzi-Rad, PhD Candidate
- Email: mohammad.goudarzirad@mail.utoronto.ca
- Phone: 647-830-5832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Depression, Opioids, respiratory depression, Capnography, sedation, Transcutaneous electrical nerve stimulation