Transcutaneous Auricular Vagus Nerve Stimulation for Reducing Postoperative Hypoxemia

ConditionHypoxemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAffiliated Hospital of Nantong University

About this trial

Hypoxemia is a common complication in the post-anesthesia care unit (PACU) and represents one of the most meaningful factors associated with poor patient prognosis. Obese patients have a relatively higher incidence of hypoxemia. This may be partly attributable to their unique physiological characteristics. In addition, surgical trauma triggers a systemic inflammatory response with the release of pro-inflammatory factors such as tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). These mediators increase pulmonary capillary permeability, induce pulmonary edema, and further impair gas exchange. Surgically-induced stress elevates sympathetic tone and reduces vagal activity, which alters bronchial tone and respiratory rhythm and consequently compromises pulmonary function.Postoperative hypoxemia not only prolongs recovery time and increases the likelihood of ICU admission, but severe episodes may also lead to arrhythmia, myocardial ischemia, long-term cognitive and psychiatric disorders, and even cardiac arrest and death. These outcomes impair postoperative recovery and long-term prognosis, prolong hospital stay, and raise healthcare costs.

Although strategies such as postoperative semi-recumbent positioning and intraoperative protective ventilation have been explored, there are currently no preferred interventions or clear clinical guidelines for the prevention of postoperative hypoxemia.

As a non-invasive technique, transcutaneous auricular vagus nerve stimulation (taVNS) activates the auricular branch of the vagus nerve by stimulating the cymba conchae. Vagal activation suppresses macrophage activity and reduces the release of pro-inflammatory cytokines including TNF-α, IL-1β, IL-6 and IL-18, thereby attenuating pulmonary inflammation and edema and improving oxygenation. Afferent vagal signals project to the nucleus tractus solitarius, modulating the medullary respiratory center, respiratory rate and ventilation efficiency. taVNS is easy to perform, safe, applicable in the perioperative period, and has shown promising effects in regulating inflammatory conditions.

This study aims to investigate whether perioperative taVNS reduces the incidence of hypoxemia in the PACU by attenuating excessive sympathetic activation and mitigating pulmonary and systemic inflammatory responses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulator

    Device

    Intervention Timing of Transcutaneous Auricular Vagus Nerve Stimulator: The intervention will begin 30 minutes before anesthesia induction and continue until the end of the surgery, terminating after the removal of the endotracheal tube in the PACU. The stimulation parameters are set as follows: frequency 20 Hz, pulse width 200 μs, 30 seconds on / 30 seconds off, with the current intensity set to the maximum amplitude the patient can tolerate (just below the pain threshold).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Transcutaneous auricular vagus nerve stimulation(taVNS group)Experimental treatment 1 intervention
Group B: Sham transcutaneous auricular vagus nerve stimulation(Sham taVNS group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Postoperative Hypoxemia in the PACU

Numerous clinical studies and consensus statements define hypoxemia as either peripheral oxygen saturation (SpO₂) less than 90% lasting for more than 10 seconds, or a partial pressure of arterial oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratio less than 300 mmHg during PACU stay.

Time frame
Within 30 minutes in the PACU postoperatively

Secondary outcomes

1

Incidence and First Onset Time of Moderate Hypoxemia in the PACU

Moderate hypoxemia is defined as SpO₂ less than 85% lasting for more than 10 seconds during PACU stay.The first onset time was defined as the time interval from extubation to the first onset of severe hypoxemia.

Time frame
Within 30 minutes in the PACU postoperatively
2

Incidence of Airway Rescue

Airway rescue was defined as the implementation of non-invasive mask ventilation or re-intubation for respiratory support.

Time frame
Within 30 minutes in the PACU postoperatively
3

Time to Extubation and PACU Length of Stay

The time interval from the end of surgical procedure to tracheal extubation. The time interval from PACU admission to PACU discharge.

Time frame
Within 30 minutes in the PACU postoperatively
4

Postoperative Respiratory Comfort Score

Respiratory comfort was evaluated using a 0-10 numerical rating scale, with higher scores indicating better respiratory comfort and lower scores indicating more severe respiratory discomfort.

Time frame
Within 30 minutes in the PACU postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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