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Study on the therapeutic effect of electroacupuncture at Tianshu Point on acute lung injury of sepsis

Registration number：

ITMCTR2025000064

Date of Last Refreshed on：

2025-01-10

Date of Registration：

2025-01-10

Registration Status：

Retrospective registration

Public title：

Study on the therapeutic effect of electroacupuncture at Tianshu Point on acute lung injury of sepsis

English Acronym：

Scientific title：

Study on the therapeutic effect of electroacupuncture at Tianshu Point on acute lung injury of sepsis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Wu Zhiyang

Study leader：

Wu Zhiyang

Applicant telephone：

+86 185 6181 2387

Study leader's telephone：

+86 185 6181 2387

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wzy838983646@126.com

Study leader's E-mail：

wzy838983646@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

758 Hefei Road Shibei District Qingdao Shandong

Study leader's address：

758 Hefei Road Shibei District Qingdao Shandong

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Qilu Hospital of Shandong University (Qingdao)

Approved by ethic committee：

Approved No. of ethic committee：

KYLL-2024028

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Qilu Hospital of Shandong University (Qingdao)

Date of approved by ethic committee：

2024/8/29 0:00:00

Contact Name of the ethic committee：

Zhang Zengfang

Contact Address of the ethic committee：

758 Hefei Road Shibei District Qingdao Shandong

Contact phone of the ethic committee：

+86 532 6685 0502

Contact email of the ethic committee：

qlyyqdky@126.com

Primary sponsor：

Qilu Hospital of Shandong University (Qingdao)

Primary sponsor's address：

758 Hefei Road Shibei District Qingdao Shandong

Secondary sponsor：

Country：

China

Province：

Shandong

City：

Qingdao

Institution
hospital：

Qilu Hospital of Shandong University (Qingdao)

Address：

758 Hefei Road Shibei District

Source(s) of funding：

self-raised

Target disease：

Acute lung injury due to sepsis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To explore the therapeutic effect of electroacupuncture at Tianshu point on acute lung injury of sepsis

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Voluntarily sign informed consent; 2. Adult patients (≥18 years old); 3. No gender restriction; 4. Meet the diagnostic criteria of sepsis and acute lung injury (ALI/ARDS).

Exclusion criteria：

1. Patients with malignant tumors end-stage patients extremely severe craniocerebral injury poor prognosis or possible death in the short term; 2. Local skin infection can not be stimulated; 3. Patients with permanent cardiac pacemaker installation; 4. Pregnant and lactating women; 5. Unable to maintain a resting state (such as epilepsy Parkinson's disease); 6. Patients or their family members do not agree to sign the test informed consent; 7. Refuse to actively treat patients who give up halfway.

Study execute time：

From 2024-09-01

To      2026-09-01

Recruiting time：

From 2024-11-15

To      2026-09-01

Interventions：

20

Group：

Electroacupuncture group

Sample size：

Intervention：

To receive the stimulation of Tianshu electroacupuncture all needles will be twisted lifted and inserted during use for at least 30 seconds in order to achieve "qi" (including acid numbness swelling pain comprehensive feeling).Electroacupuncture parameters: The density wave of 2/100 Hz is selected and the current intensity is gradually increased until the needle vibrates slightly but does not cause discomfort to the patient.

Intervention code：

20

Group：

Sham Electroacupuncture group

Sample size：

Intervention：

Superficial skin puncture (depth of 2 to 3 mm) is performed at non-Tianshu points, and no qi acupuncture operation is performed; The location of non-Tianshu points is far away from the traditional Tianshu points or meridians

Intervention code：

Total sample size ： 40

Countries of recruitment
and research settings：

Country：

China

Province：

Shandong

City：

Qingdao

Institution/hospital：

Qilu Hospital of Shandong University (Qingdao)

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Oxygenation index (P/F)

Type：

Primary indicator

Measure time point of outcome：

Day 0 day 5 after enrollment

Measure method：

Outcome：

Safety Indicators: Side Effects and Adverse Reactions of Electroacupuncture Treatment: Document any adverse events related to electroacupuncture.

Type：

Secondary indicator

Measure time point of outcome：

Within 28 days after enrollment

Measure method：

Outcome：

Clinical Symptoms and Signs: Degree of Dyspnea: Assessed using a subjective scoring scale to evaluate the patient's level of breathlessness.

Type：

Secondary indicator

Measure time point of outcome：

Day 1 3 5 7 after enrollment

Measure method：

Outcome：

ICU stay

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Vital Signs: Including heart rate, blood pressure, and body temperature

Type：

Secondary indicator

Measure time point of outcome：

Day 1 3 5 7 after enrollment

Measure method：

Outcome：

Respiratory function: lung compliance respiratory rate tidal volume mechanical ventilation time

Type：

Secondary indicator

Measure time point of outcome：

Day 0, day 1,day 2,day 3,day 5 and day 7 after enrollment

Measure method：

Outcome：

28 day mortality

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Bronchoalveolar lavage fluid inflammatory indicators

Type：

Secondary indicator

Measure time point of outcome：

Day 0, day 1 and day 7 after enrollment

Measure method：

Outcome：

SOFA score and APACHE II score

Type：

Secondary indicator

Measure time point of outcome：

Day 1,3,5,7 after enrollment

Measure method：

Outcome：

Chest X-ray or CT image

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum inflammatory factor levels

Type：

Secondary indicator

Measure time point of outcome：

Day 0, day 1,day 2,day 3,day 5 and day 7 after enrollment

Measure method：

Outcome：

Ventilator parameters: HR, MAP, RR and other vital signs; PaO2, PaCO2, Lac and other blood gas indicators

Type：

Secondary indicator

Measure time point of outcome：

Day 0, day 1,day 2,day 3,day 5 and day 7 after enrollment

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Bronchoalveolar lavage fluid

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Stool

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
100
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Patients meeting the inclusion/exclusion criteria will be randomly entered into the electroacupuncture group and the fake electroacupuncture group by the specialized staff of the research group in a 1:1 ratio according to the random number method.

Blinding：

Single blind

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

http://www.medresman.org.cn/uc/index.aspx

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF table was used for data collection and single entry with manual review was used for data management.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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