ExtubationNCT06772961
Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events
A study testing Transcutaneous electrical acupoint stimulation and Conventional care plan in people with Extubation and Respiratory Depression, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Extubation, Respiratory Depression, Acupuncture Points
- What is being tested?
- Transcutaneous electrical acupoint stimulation and Conventional care plan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jan 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1: Age >18 years old.
- 2: ASA I-III
- 3: Patients undergoing elective general anesthesia surgery who are extubated upon arrival to the PACU
Who cannot join
- 1: Preoperative comorbidities include severe cardiovascular or respiratory diseases
- 2: Serious reflux aspiration during the perioperative period
- 3: Concurrent psychiatric disorders
- 4: Local skin infections or nerve damage at the upper limb Taiyuan and Hegu acupoints
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
zhang ying, Master degree, 86+15380998716, 1070434273@qq.com
wang xiao liang, Doctor, 86+13776615743
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 221006
Xiaoliang Wang, +8613776615743, wxl145381@njmu.edu.cn
About this study
Official title: Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events in the Emergence Period From General Anesthesia After Tracheal Extubation: A Single-center Randomized Controlled Study
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.
Read more
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."
Read the detailed description
According to domestic and international studies, apnea, respiratory depression, desaturation, hypoxemia, and severe hypoxia are documented as adverse respiratory events during the recovery period. The post-anesthesia recovery phase is a high-risk period for hypoxemia. A brief decrease in SpO2 may indicate the onset of respiratory adverse events such as hypoxemia and severe hypoxia. Patients in the Post Anesthesia Care Unit (PACU) are in the early stages of awakening from general anesthesia, where their spontaneous breathing function gradually recovers. However, some patients may still experience residual effects of muscle relaxants or analgesics that lead to respiratory depression. After the removal of mechanical ventilation, patients often experience a decrease in SpO2. In an analysis by Wu Qiao et al. on the incidence of respiratory adverse events during the recovery period after extubation in gastrointestinal oncology patients under general anesthesia, the incidence of apnea was 50.85%, and respiratory depression occurred in 42.8% of cases. Notably, extubation in the PACU after general anesthesia marks a critical point in the transition from assisted to spontaneous breathing. Therefore, the incidence of respiratory adverse events in the early post-extubation period in the PACU is high. Desaturation, hypoxemia, and severe hypoxia in many patients are secondary to apnea or respiratory depression, and if not intervened in time, hypoxemia can occur and potentially endanger the patient's life. Hence, how to effectively reduce the incidence of respiratory adverse events in patients after general anesthesia extubation has become a focus of research in both academic and clinical practice.
Moreover, as China's aging population grows and medical technology continues to advance, the number of patients at risk for post-anesthesia hypoxemia is increasing. In the face of a significant rise in the workload of post-anesthesia recovery rooms, the capacity of PACU medical staff to anticipate and manage respiratory adverse events has not yet met clinical demands.
Transcutaneous electrical acupoint stimulation (TEAS) merges transcutaneous electrical nerve stimulation with acupoint therapy. Rooted in acupuncture, it offers similar effects and is characterized by its simplicity, safety, non-invasiveness, and fewer complications. TEAS functions by stimulating nerve fiber endings to generate action potentials, which are then transmitted to the spinal cord and brain, leading to the release of related chemical mediators and producing corresponding physiological effects. This study selected the primary acupoint Taiyuan (LU9) on the lung meridian and Hegu (LI4) on the large intestine meridian. The lung and large intestine meridians are interconnected, and the combined use of Taiyuan and Hegu acupoints with TEAS can have a synergistic effect, enhancing the replenishment of lung qi, promoting the flow of meridians, regulating qi, and disseminating lung functions. It can effectively stimulate patients' breathing, thereby improving oxygen saturation. However, there are currently few prospective studies on the role of TEAS with Taiyuan and Hegu in reducing the incidence of respiratory adverse events after extubation in patients during the recovery period of general anesthesia, and further in-depth exploration is needed.
Therefore, this study will employ the combined acupoint TEAS stimulation of Taiyuan and Hegu as an intervention method, aiming to explore its role in improving the incidence of respiratory adverse events after extubation in patients during the post-anesthesia recovery period. The goal is to provide more reliable scientific evidence for clinical practice. This study aims to offer new theoretical support for the nursing care of patients after extubation during the post-anesthesia recovery period and provide new ideas and methods for further improving patients' quality of life and surgical treatment outcomes.
- Conditions
- Extubation, Respiratory Depression, Acupuncture Points, Hypoxia
- Being tested
- Transcutaneous electrical acupoint stimulation, Conventional care plan
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationOther
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.
Conventional care planOther
Conventional care plan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Transcutaneous electrical acupoint stimulation |
| Control group | Placebo comparator | conventional care plan Receives: Other: Conventional care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: After the patient enters the PACU from general anesthesia
Secondary outcomes (1)
General adverse events other than hypoxia
Including vomiting, regurgitation, aspiration, bronchospasm, choking,
Measured: After the patient enters the PACU from general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start25 Jan 2025
- Primary completion20 Nov 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaoliang wang, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772961
- Sponsor's protocol ID
- KY20240613-06-KS-01
- Status last verified
- Feb 2025
- First submitted
- 1 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the privacy of participants, researchers decided not to make the data public. To obtain relevant data, researchers can be contacted if necessary.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events in the Emergence Period From General Anesthesia After Tracheal Extubation: A Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06772961
- Acronym / sponsor ID
- KY20240613-06-KS-01
- Conditions
- Extubation, Respiratory Depression, Acupuncture Points, Hypoxia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Detailed description
According to domestic and international studies, apnea, respiratory depression, desaturation, hypoxemia, and severe hypoxia are documented as adverse respiratory events during the recovery period. The post-anesthesia recovery phase is a high-risk period for hypoxemia. A brief decrease in SpO2 may indicate the onset of respiratory adverse events such as hypoxemia and severe hypoxia. Patients in the Post Anesthesia Care Unit (PACU) are in the early stages of awakening from general anesthesia, where their spontaneous breathing function gradually recovers. However, some patients may still experience residual effects of muscle relaxants or analgesics that lead to respiratory depression. After the removal of mechanical ventilation, patients often experience a decrease in SpO2. In an analysis by Wu Qiao et al. on the incidence of respiratory adverse events during the recovery period after extubation in gastrointestinal oncology patients under general anesthesia, the incidence of apnea was 50.85%, and respiratory depression occurred in 42.8% of cases. Notably, extubation in the PACU after general anesthesia marks a critical point in the transition from assisted to spontaneous breathing. Therefore, the incidence of respiratory adverse events in the early post-extubation period in the PACU is high. Desaturation, hypoxemia, and severe hypoxia in many patients are secondary to apnea or respiratory depression, and if not intervened in time, hypoxemia can occur and potentially endanger the patient's life. Hence, how to effectively reduce the incidence of respiratory adverse events in patients after general anesthesia extubation has become a focus of research in both academic and clinical practice.
Moreover, as China's aging population grows and medical technology continues to advance, the number of patients at risk for post-anesthesia hypoxemia is increasing. In the face of a significant rise in the workload of post-anesthesia recovery rooms, the capacity of PACU medical staff to anticipate and manage respiratory adverse events has not yet met clinical demands.
Transcutaneous electrical acupoint stimulation (TEAS) merges transcutaneous electrical nerve stimulation with acupoint therapy. Rooted in acupuncture, it offers similar effects and is characterized by its simplicity, safety, non-invasiveness, and fewer complications. TEAS functions by stimulating nerve fiber endings to generate action potentials, which are then transmitted to the spinal cord and brain, leading to the release of related chemical mediators and producing corresponding physiological effects. This study selected the primary acupoint Taiyuan (LU9) on the lung meridian and Hegu (LI4) on the large intestine meridian. The lung and large intestine meridians are interconnected, and the combined use of Taiyuan and Hegu acupoints with TEAS can have a synergistic effect, enhancing the replenishment of lung qi, promoting the flow of meridians, regulating qi, and disseminating lung functions. It can effectively stimulate patients' breathing, thereby improving oxygen saturation. However, there are currently few prospective studies on the role of TEAS with Taiyuan and Hegu in reducing the incidence of respiratory adverse events after extubation in patients during the recovery period of general anesthesia, and further in-depth exploration is needed.
Therefore, this study will employ the combined acupoint TEAS stimulation of Taiyuan and Hegu as an intervention method, aiming to explore its role in improving the incidence of respiratory adverse events after extubation in patients during the post-anesthesia recovery period. The goal is to provide more reliable scientific evidence for clinical practice. This study aims to offer new theoretical support for the nursing care of patients after extubation during the post-anesthesia recovery period and provide new ideas and methods for further improving patients' quality of life and surgical treatment outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Other: Transcutaneous electrical acupoint stimulationTranscutaneous 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 |
| Control group | Placebo comparator | Other: Conventional care planconventional care plan |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1: Age >18 years old.
- 2: ASA I-III
- 3: Patients undergoing elective general anesthesia surgery who are extubated upon arrival to the PACU
Key exclusion criteria (4 listed)
- 1: Preoperative comorbidities include severe cardiovascular or respiratory diseases
- 2: Serious reflux aspiration during the perioperative period
- 3: Concurrent psychiatric disorders
- 4: Local skin infections or nerve damage at the upper limb Taiyuan and Hegu acupoints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulationIn 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. | Other | TEAS group |
| Conventional care planConventional care plan | Other | Control group |
Primary outcome
Respiratory adverse events
Time frame: After the patient enters the PACU from general anesthesia
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%.
1 secondary outcome
General adverse events other than hypoxia
Time frame: After the patient enters the PACU from general anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. In order to protect the privacy of participants, researchers decided not to make the data public. To obtain relevant data, researchers can be contacted if necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
xiaoliang wang study director
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation and Conventional care plan in people with Extubation and Respiratory Depression, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hua guan (+8618951670974, 821278639@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory adverse events (time frame: After the patient enters the PACU from general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.