Respiratory Insufficiency Requiring Mechanical VentilationNCT05221710
Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients
A study testing electroacupuncture in people with Respiratory Insufficiency Requiring Mechanical Ventilation, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency Requiring Mechanical Ventilation
- What is being tested?
- electroacupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555
About this study
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
- Being tested
- electroacupuncture
- Keywords
- Respiratory Failure, weaning difficulty
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | No intervention | 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) |
| Electroacupuncture Group | Experimental | On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation Receives: Behavioral: electroacupuncture |
| Neuromuscular Electrical Stimulation Group | No intervention | Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-free days at 28 days
Measured: up to 28days
Secondary outcomes (2)
Diaphragmatic thickening fraction(DTF)
DTF shows varied thickness of the diaphragm at end-expiration and end-inspiration. Te maximum and minimum values of each breathing cycle were taken as the end-inspiratory diaphragm thickness (DTei) and the end-expiratory diaphragm thickness (DTee), respectively. DTF was calculated by DTF=(DTei DTee)/DTee 100%. The values for 3 consecutive respiratory cycles were recorded and the average value was taken as the final value
Measured: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Parasternal Intercostal Muscle Ultrasound
A 10-15 MHz linear array transducer was positioned perpendicular to the anterior thorax surface in the longitudinal scan, at the level of the second right intercostal space, approximately 6 to 8 cm lateral to the sternal edge with a window visualizing the second and third ribs. . Using M-mode, the ultrasound beam was perpendicularly directed at the midsection of the muscle, where it is the thinnest at end-expiration. The thickness of the parasternal intercostal muscle was measured on frozen images at end expiration and at peak inspiration.
Measured: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency Requiring Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JinyanXing, The Affiliated Hospital of Qingdao University
- Investigators
- Jinyan Xing, Dr., Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221710
- Sponsor's protocol ID
- QYFYWZLL26719
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients
- ClinicalTrials.gov ID
- NCT05221710
- Acronym / sponsor ID
- QYFYWZLL26719
- Keywords
- Respiratory Failure, weaning difficulty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 3 Feb 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | No intervention | –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) |
| Electroacupuncture Group | Experimental | Behavioral: electroacupunctureOn the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation |
| Neuromuscular Electrical Stimulation Group | No intervention | –Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| electroacupunctureThe 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. | Behavioural | Electroacupuncture Group |
Primary outcome
ventilator-free days at 28 days
Time frame: up to 28days
2 secondary outcomes
Diaphragmatic thickening fraction(DTF)
Time frame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Parasternal Intercostal Muscle Ultrasound
Time frame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jinyan Xing, Dr. study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Respiratory Insufficiency Requiring Mechanical Ventilation, run by The Affiliated Hospital of Qingdao University at 1 site 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 7 inclusion and 13 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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Zehua Dong, Dr. (86-0532-82919386, liuyingwallace@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator-free days at 28 days (time frame: up to 28days). 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 3 Feb 2022.