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

Primary Purpose

Respiratory Insufficiency Requiring Mechanical Ventilation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency Requiring Mechanical Ventilation focused on measuring Respiratory Failure, weaning difficulty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Affiliated Hospital of Qingdao University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Acupuncture Group

Electroacupuncture Group

Neuromuscular Electrical Stimulation Group

Arm Description

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)

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

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

Outcomes

Primary Outcome Measures

ventilator-free days at 28 days

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 9, 2022
Last Updated
January 29, 2022
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05221710
Brief Title
Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients
Official Title
Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency Requiring Mechanical Ventilation
Keywords
Respiratory Failure, weaning difficulty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture Group
Arm Type
No Intervention
Arm Description
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)
Arm Title
Electroacupuncture Group
Arm Type
Experimental
Arm Description
On the basis of the above acupuncture treatment,two points that do not cross the joint will be chosen for electrical stimulation
Arm Title
Neuromuscular Electrical Stimulation Group
Arm Type
No Intervention
Arm Description
Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points
Intervention Type
Behavioral
Intervention Name(s)
electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
ventilator-free days at 28 days
Time Frame
up to 28days
Secondary Outcome Measure Information:
Title
Diaphragmatic thickening fraction(DTF)
Description
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
Time Frame
baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Title
Parasternal Intercostal Muscle Ultrasound
Description
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.
Time Frame
baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehua Dong, Dr.
Phone
86-0532-82919386
Email
liuyingwallace@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyan Xing, Dr.
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266555
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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