Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events

NCT06772961 | Recruiting DMC

• 1 other identifier: KY20240613-06-KS-01
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to investigate the effect of combined acupoint electrical stimulation at Taiyuan (LU9) and Hegu (LI4) on improving the incidence of respiratory adverse events after extubation in patients during the recovery period from general anesthesia. The main content of this study involves selecting patients who have undergone general anesthesia and are admitted to the Post Anesthesia Care Unit (PACU), with an expected 236 participants. The researchers will randomly assign participants to either the TEAS group or the control group using a random number table. In the TEAS group, electrodes will be applied to the upper limbs at the Taiyuan and Hegu acupoints, without intravenous infusion, and connected to a stimulation device. The stimulation will use a frequency of 2/100 Hz with sparse-dense waves, and the intensity will be adjusted to the maximum current that the patient can tolerate, starting at the time of extubation and continuing for 30 minutes. The control group will receive routine care. Throughout the process, no invasive procedures will be performed. In the PACU, the participants will: Be positioned in a 30° head-up tilt position, with continuous ECG monitoring. The SpO2 alarm on the monitor will be set to 95%. The same anesthesiologist will perform extubation according to the extubation criteria. After extubation, participants will receive routine oxygen therapy via a nasal cannula at 3L/min with a CO2 end-expiratory monitoring module attached to the other end of the cannula. Simultaneously, the TEAS group will undergo transcutaneous electrical stimulation for 30 minutes, or the control group will receive routine care. Participants will be observed in the PACU for at least 30 minutes. If no adverse events occur and the Steward score is ≥4, the patient will be deemed ready for discharge and escorted back to the ward. If there is any significant change in the patient's condition, they will be transferred to the ICU . If any respiratory-related adverse events occur, measures such as awakening the patient, supporting the jaw, increasing oxygen flow, or administering mask oxygen will be taken to ensure patient safety, and these events will be recorded in the "PACU Postoperative General Anesthesia Patient Condition Observation and Nursing Record."

Conditions

Extubation; Respiratory Depression; Acupuncture Points; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Respiratory adverse events

  In this study, the respiratory status of patients was monitored using PetCO2 in conjunction with SpO2, and adverse respiratory events such as apnea, respiratory depression, desaturation, hypoxemia, and severe hypoxia were recorded during the recovery period of general anesthesia. Based on other studies, apnea in this study is defined as the cessation of the end-tidal CO2 waveform for a duration exceeding 20-30 seconds; respiratory depression is characterized by a respiratory rate of ≤5 breaths per minute, PetCO2 ≤15mmHg (1mmHg=0.133kPa) or ≥55mmHg, a change of ≥10mmHg from the baseline, or the absence of the end-tidal CO2 waveform for ≥30 seconds; desaturation refers to a decrease in SpO2, specifically when SpO2 drops to a range of 95% to 90% and persists for over 15 seconds; hypoxemia is indicated by an arterial oxygen partial pressure below 60mmHg or when SpO2 is between 90% and 85%; and severe hypoxia is defined as SpO2 falling below 85%.

  After the patient enters the PACU from general anesthesia

Secondary Outcomes (1)

• General adverse events other than hypoxia

  After the patient enters the PACU from general anesthesia

Other Outcomes (1)

• Adverse events related to transcutaneous electrical stimulation

  After the patient enters the PACU from general anesthesia

Study Arms (2)

TEAS group

EXPERIMENTAL

Transcutaneous electrical acupoint stimulation (TEAS) merges transcutaneous electrical nerve stimulation with acupoint therapy. It has its roots in acupuncture and shares similar effects, while being distinguished by its simplicity, safety, non-invasiveness, and reduced complications. TEAS functions by stimulating nerve fiber endings, which generates action potentials that are transmitted to the spinal cord and brain, subsequently triggering the release of related chemical mediators and producing corresponding physiological effects. In this study, the traditional acupoints Taiyuan on the lung meridian and Hegu on the large intestine meridian were selected. The lung and large intestine meridians are interconnected, so the combined application of Taiyuan and Hegu acupoints with TEAS can produce a synergistic effect. This combination enhances the replenishment of lung qi, promotes the flow of meridians, regulates qi, and disseminates lung functions. It can stimulate effective

Other: Transcutaneous electrical acupoint stimulation

Control group

PLACEBO COMPARATOR

conventional care plan

Other: Conventional care plan

Interventions

Transcutaneous electrical acupoint stimulation OTHER

In this study, the traditional acupoints Taiyuan (LU9) on the lung meridian and Hegu (LI4) on the large intestine meridian were selected. The lung and large intestine meridians are interconnected, so the combined application of Taiyuan and Hegu acupoints with TEAS can produce a synergistic effect. This combination enhances the replenishment of lung qi, promotes the flow of meridians, regulates qi, and disseminates lung functions. It can stimulate effective breathing in patients, thus positively influencing the improvement of their oxygen saturation levels.

TEAS group

Conventional care plan OTHER

Conventional care plan

Control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Age \>18 years old.
• : ASA I-III
• : Patients undergoing elective general anesthesia surgery who are extubated upon arrival to the PACU

You may not qualify if:

• : Preoperative comorbidities include severe cardiovascular or respiratory diseases
• : Serious reflux aspiration during the perioperative period
• : Concurrent psychiatric disorders
• : Local skin infections or nerve damage at the upper limb Taiyuan and Hegu acupoints

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (2)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 221006, China

NOT YET RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• xiaoliang wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

hua guan

CONTACT

+8618951670974; 821278639@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 14, 2025
• Study Start: January 25, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 25, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)