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Search / Trial NCT06823661

Transcutaneous Electrical Stimulation for Apnea Detected by Capnography

Launched by UNIVERSITY OF TORONTO · Feb 6, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Respiratory Depression Capnography Sedation Transcutaneous Electrical Nerve Stimulation (Tens)

ClinConnect Summary

This clinical trial is studying a new way to help patients breathe better after surgery, especially when they're receiving pain medications like opioids that can slow down their breathing. In the Post Anesthesia Care Unit (PACU), where patients recover, nurses usually monitor breathing and oxygen levels. This study introduces a tool called capnography that measures the carbon dioxide patients exhale to detect if their breathing slows down or stops. If that happens, the study will test a technique called transcutaneous electrical stimulation (TES), which uses a gentle electrical pulse to safely encourage patients to take deeper breaths.

To be eligible for this study, participants need to be adults aged 18 and older who had general anesthesia during elective surgeries and are currently recovering in the PACU. They should be able to understand the study and provide consent. If someone joins the study, they can expect to have this new monitoring system in place, which may help ensure their breathing stays safe while they recover. This research aims to make recovery from surgery safer and more comfortable by reducing the risks associated with opioid use.

Gender

ALL

Eligibility 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

About University Of Toronto

The University of Toronto, a prestigious research institution, serves as a leading sponsor of clinical trials dedicated to advancing medical knowledge and improving patient care. With a commitment to innovation and excellence, the university fosters a collaborative environment that brings together multidisciplinary teams of experts in medicine, pharmacology, and public health. Through rigorous research methodologies and ethical standards, the University of Toronto aims to explore new therapies, assess treatment efficacy, and address critical health challenges, ultimately contributing to the global body of scientific knowledge and enhancing healthcare outcomes.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported