Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients

NCT ID: NCT05221710

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-08-31

Brief Summary

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Acupuncture is a treatment intervention used globally for a wide variety of disorders. Its efficacy has been established over the course of 3000 years, originating in Asia and diversifying worldwide.The scientific basis for acupuncture remains unclear. Nonetheless, acupuncture releases neurochemical substrates, such as endorphins, serotonin, and norepinephrine.Acupuncture is considered to be a safe treatment when applied by a certified acupuncturist.Acupuncture has already been deployed in the treatment of sepsis or muscle weakness.Studies have revealed that acupuncture significantly improved grip strength and respiratory muscle strength in chronic obstructive pulmonary disease participates.Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.The investigators designed a study to compare the effects of acupuncture, electroacupuncture, and neuromuscular electrical stimulation on mechanical ventilation patients with weaning difficulties

Detailed Description

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Conditions

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Respiratory Insufficiency Requiring Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupuncture Group

The acupuncture treatment will be performed by the technique of lifting, thrusting, twirling and rotating the needle until the patient is being "De-qi" (getting a numbness or other acupuncture feeling)

Group Type NO_INTERVENTION

No interventions assigned to this group

Electroacupuncture Group

On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type BEHAVIORAL

The acupuncture treatment will be performed by the technique of lifting, thrusting, twirling and rotating the needle until the patient is being "De-qi" (getting a numbness or other acupuncture feeling).The needle will be kept in place for approximately 30 minutes. The point of acupuncture is determined by a traditional Chinese medicine doctor.

Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points.

On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation in electroacupuncture group.

Neuromuscular Electrical Stimulation Group

Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electroacupuncture

The acupuncture treatment will be performed by the technique of lifting, thrusting, twirling and rotating the needle until the patient is being "De-qi" (getting a numbness or other acupuncture feeling).The needle will be kept in place for approximately 30 minutes. The point of acupuncture is determined by a traditional Chinese medicine doctor.

Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points.

On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation in electroacupuncture group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Prolonged mechanical ventilation duration (\>72 h)
* stable oxygen saturation, fraction of inspired oxygen≤55%, and positive end expiratory pressure (PEEP)≤8 cmH2O
* dose of dopamine\<10 μg/kg/min and dose of epinephrine\<0.4 μg/kg/min;
* mean arterial pressure\>75 mmHg and urine output\>1 mL/kg/h
* good healing of the incision after surgery;
* normal cognitive function
* no history of chronic mental illness or chronic obstructive pulmonary disease

Exclusion Criteria

* Inability to perform physical activities
* long-term MV prior to admission
* neurological comorbidities involving muscles
* irreversible disorders with a 6-month mortality rate of\>50% according to Acute Physiology and Chronic Health Evaluation II (APACHEII)
* unsound limbs or unstable fractures
* administration of glucocorticoids (prednisone or other corticosteroid dose equivalents\>20 mg/day) for at least 20 days prior to admission
* cardiopulmonary resuscitation before admission to the ICU
* radiotherapy or chemotherapy within the previous 6 months
* presence of comorbidities, including acute myocarditis, deep venous thrombosis/embolism, and cerebrovascular accident
* Patients with implanted pacemakers or defibrillators
* Pregnancy and lactation patients
* Patients with active bleeding or bleeding tendency
* Skin infection or injury at the acupuncture site
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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JinyanXing

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinyan Xing, Dr.

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Central Contacts

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Zehua Dong, Dr.

Role: CONTACT

86-0532-82919386

Other Identifiers

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QYFYWZLL26719

Identifier Type: -

Identifier Source: org_study_id

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