NCT06772961

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

Recruiting now NA Last updated 10 February 2025

What this trial tests

NA trial testing Transcutaneous electrical acupoint stimulation in Extubation in 236 participants. Currently enrolling.

Timeline

25 January 2025

Primary endpoint
20 November 2025

25 December 2025

Quick facts

Lead sponsor	Nanjing First Hospital, Nanjing Medical University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	236
Start date	25 January 2025
Primary completion	20 November 2025
Estimated completion	25 December 2025
Sites	2 locations across China

Drugs / interventions tested

• Transcutaneous electrical acupoint stimulation
• Conventional care plan

Conditions studied

• Extubation — all drugs for Extubation →
• Respiratory Depression — all drugs for Respiratory Depression →
• Acupuncture Points — all drugs for Acupuncture Points →
• Hypoxia — all drugs for Hypoxia →

Sponsor

Nanjing First Hospital, Nanjing Medical University

Who can join

Adults 18 to 100, any sex, with Extubation or Respiratory Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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."

Publications & conference data

No peer-reviewed publications indexed yet for this trial.