ElectroacupunctureNCT05019079
Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
A study testing electroacupuncture in people with Electroacupuncture and Lung Injury, Ventilator Induced, run by Lingling Ding.
Trial summary
Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Electroacupuncture, Lung Injury, Ventilator Induced
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing general anesthesia in our hospital;
- Ages 18-60;
- American Society of Anesthesiologists (ASA) grade ⅱ ~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
- Expected duration of operation >2h;
- Surgical grade 2-4;
- No serious lung infection and lung disease;
- Body mass index (BMI) 18~30 kg/m2; There are no contraindications for electroacupuncture stimulation.
Who cannot join
- Patients with severe circulatory or other system dysfunction;
- Patients with pulmonary and one-lung ventilation;
- Unwilling to cooperate with the patient;
- Patients with low compliance.
Trial locations and contacts
No sites are listed yet.
About this study
Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia
Read the detailed description
Randomized parallel control study. From September 1, 2021 to December 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. The blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical ventilation.
- Being tested
- electroacupuncture
- Keywords
- Electroacupuncture, Lung protection, ventilator induced lung injury
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation will be stopped 30min later.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture group | Experimental | In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation was stopped 30min later. Receives: Other: electroacupuncture |
| control group | No intervention | The patient underwent routine anesthesia without acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation index
record oxygenation index
Measured: Before anesthesia
oxygenation index
record oxygenation index
Measured: 2 hours after tracheal intubation
oxygenation index
record oxygenation index
Measured: 5 minutes after tracheal intubation removal
Secondary outcomes (19)
Postoperative comfort score
Assess the quality of recovery during recovery
Measured: during anesthesia recovery period
sedation score (Ramsay)
Assess the quality of recovery during recovery
Measured: during anesthesia recovery period
restfulness score (DRS)
Assess the quality of recovery during recovery
Measured: during anesthesia recovery period
visual analogue scale (VAS)
Assess the quality of recovery during recovery
Measured: during anesthesia recovery period
Length of stay
Assess the quality of postoperative recovery
Measured: 1 week after discharge, the patient's length of stay will be recorded through medical record system
postoperative time in hospital
Assess the quality of postoperative recovery
Measured: 1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system
postoperative complications of major organs
Assess the quality of postoperative recovery
Measured: Major organ complications during hospitalization，assessed up to 30 days after surgery
mortality within 30 days
Assess the quality of postoperative recovery
Measured: mortality within 30 days will be recorded
Expression of IL-18 in serum
The perioperative inflammation level will be assessed
Measured: Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Expression of IL-18 in serum
The perioperative inflammation level will be assessed
Measured: 5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Expression of IL-1β in serum
The perioperative inflammation level will be assessed
Measured: Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Expression of IL-1β in serum
The perioperative inflammation level will be assessed
Measured: 5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Expression of IL-10 in serum
The perioperative inflammation level will be assessed
Measured: Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Expression of IL-10 in serum
The perioperative inflammation level will be assessed
Measured: 5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Mean arterial pressure
Intraoperative vital signs will be recorded
Measured: Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
heart rate
Intraoperative vital signs will be recorded
Measured: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
BIS
Intraoperative vital signs will be recorded
Measured: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
extubation time
Intraoperative vital signs will be recorded
Measured: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
anesthesia dosage
Intraoperative vital signs will be recorded
Measured: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingling Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingling Ding, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019079
- Sponsor's protocol ID
- LDing
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT05019079
- Acronym / sponsor ID
- LDing
- Keywords
- Electroacupuncture, Lung protection, ventilator induced lung injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lingling DingUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Aug 2021 (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.
Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia
Detailed description
Randomized parallel control study. From September 1, 2021 to December 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. The blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Other: electroacupunctureIn the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation was stopped 30min later. |
| control group | No intervention | –The patient underwent routine anesthesia without acupuncture treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients undergoing general anesthesia in our hospital;
- Ages 18-60;
- American Society of Anesthesiologists (ASA) grade ⅱ ~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
- Expected duration of operation >2h;
- Surgical grade 2-4;
Key exclusion criteria (4 listed)
- Patients with severe circulatory or other system dysfunction;
- Patients with pulmonary and one-lung ventilation;
- Unwilling to cooperate with the patient;
- Patients with low compliance.
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 |
|---|---|---|
| electroacupunctureIn the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation will be stopped 30min later. | Other | electroacupuncture group |
Primary outcome
oxygenation index
Time frame: Before anesthesia
record oxygenation index
oxygenation index
Time frame: 2 hours after tracheal intubation
record oxygenation index
oxygenation index
Time frame: 5 minutes after tracheal intubation removal
record oxygenation index
19 secondary outcomes
Postoperative comfort score
Time frame: during anesthesia recovery period
sedation score (Ramsay)
Time frame: during anesthesia recovery period
restfulness score (DRS)
Time frame: during anesthesia recovery period
visual analogue scale (VAS)
Time frame: during anesthesia recovery period
Length of stay
Time frame: 1 week after discharge, the patient's length of stay will be recorded through medical record system
postoperative time in hospital
Time frame: 1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system
postoperative complications of major organs
Time frame: Major organ complications during hospitalization，assessed up to 30 days after surgery
mortality within 30 days
Time frame: mortality within 30 days will be recorded
Expression of IL-18 in serum
Time frame: Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Expression of IL-18 in serum
Time frame: 5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Expression of IL-1β in serum
Time frame: Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Expression of IL-1β in serum
Time frame: 5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Expression of IL-10 in serum
Time frame: Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Expression of IL-10 in serum
Time frame: 5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Mean arterial pressure
Time frame: Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
heart rate
Time frame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
BIS
Time frame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
extubation time
Time frame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
anesthesia dosage
Time frame: Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Electroacupuncture and Lung Injury, Ventilator Induced, run by Lingling Ding.
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 7 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingling Ding, Doctor (+86 010 52176647, dinglingling301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation index (time frame: Before anesthesia). The study lists 3 primary outcomes in all. 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 24 Aug 2021.