Actively Recruiting
Transcutaneous Electrical Stimulation for Apnea Detected by Capnography
Led by University of Toronto · Updated on 2025-05-01
60
Participants Needed
2
Research Sites
89 weeks
Total Duration
On this page
Sponsors
U
University of Toronto
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Electrical Stimulation for Apnea Detected by Capnography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females at least 18 years old
- Adults undergoing elective general anesthesia surgeries (General, Plastics, Urology, Gynecologic Oncology, Vascular, Otolaryngology, Transplant)
- Recovering in the Post Anesthesia Care Unit (PACU)
- American Society of Anesthesiologists (ASA) grade I to IV
- Scheduled for Pre-Admission Clinic or Surgery Inpatient Unit visit
- Able to complete questionnaires with or without assistance
- Able to understand study protocol, risks, and provide written informed consent
You will not qualify if you...
- American Society of Anesthesiologists (ASA) grade V or VI
- Urgent or emergent surgeries without time for study participation
- Presence of implantable electronic medical devices (e.g., pacemaker, defibrillator, catheter)
- Febrile illnesses or acute infections
- Pregnancy
- Epilepsy
- Surgery preventing use of nasal cannula or face mask for capnography (e.g., facial reconstruction)
- Postoperative mental status preventing use of study equipment (e.g., delirium, agitation)
- Postoperative admission to ICU or outside PACU
- Need for assisted ventilation via endotracheal tube or tracheostomy
- Abnormal respiratory tract causing severe obstruction
- Cardiac arrhythmia history (atrial fibrillation or bundle branch block)
- Skin conditions preventing electrode placement
- Metal implants in both arms
- Lack of access to upper extremities after surgery for electrode placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Toronto General Hospital
Toronto, Ontario, Canada, M4Y 1R6
Active, Not Recruiting
2
Toronto General Hospital
Toronto, Canada
Actively Recruiting
Research Team
M
Mohammad Goudarzi-Rad, PhD Candidate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here