Back to resultsElectroacupuncture to Assist Ventilator Weaning in Severe Stroke
Primary Purpose
Severe Stroke, Electroacupuncture
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Severe Stroke focused on measuring ventilator weaning, severe stroke, electroacupuncture
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years and ≤ 75 years ;
- within 7 days after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain;
- GCS on admission ≤ 12 or NIHSS on admission ≥ 11 or APACHEⅡ ≥ 15;
- received mechanical ventilation;
- written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.
Exclusion Criteria:
- expected to be ventilated for < 24 h;
- already ventilated for > 72 h;
- GCS <5;
- with unstable vital signs and requiring the use of vasoactive agents;
- concomitant medical illness that would interfere with the outcome assessments and/or follow-up;
- had spinal cord injury above T8 level, or lower motor neuron impairment, or neuromuscular junction impairment，or chest wall deformities, or chest wall injuries within 6 months, or chest or abdominal surgery within 4 week, or were pregnant;
- had acute skin injury on the selected acupoints;
- currently participating in other investigational trials.
Sites / Locations
- The Second Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electroacupuncture
Sham electroacupuncture
Arm Description
Participants in the electroacupuncture group received acupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36). After skin disinfection, sterile adhesive pads were placed on these acupoints, and acupuncture needles were inserted through the adhesive pads approximately 50 to 60 mm into the skin. Paired electrodes from the electroacupuncture apparatus were attached to the needle handles of Xuanji (CV21) and Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), bilateral Liangmen (ST21), and bilateral Zusanli (ST36). The electroacupuncture stimulation lasted for 30 minutes with an intermittent wave of 50 Hz and a current intensity of 1 to 5mA (preferably with the skin around the acupoints shivering mildly without pain). Participants received 1 treatment session per day until the success of ventilator weaning (up to 21 days).
Participants in the sham electroacupuncture group received sham electroacupuncture with a pragmatic placebo needle on sham acupoints. The sham Xuanji (CV21) point was 1 cun (≈20 mm) above to Xuanji (CV21), the sham Danzhong (CV27) point was 1 cun(≈20mm) above to Danzhong (CV27), the sham Qihai (CV06) point was 1 cun(≈20mm) above to Qihai (CV06), the sham Guanyuan (CV04) point was 1 cun(≈20mm) above to Guanyuan (CV04), the sham Liangmen (ST21) point was 1 cun(≈20mm) lateral to Liangmen (ST21), and the sham Zusanli (ST36) point was 1 cun(≈20mm) lateral to Zusanli (ST36). Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no skin penetration or electricity output.
Outcomes
Primary Outcome Measures
ventilation duration
hours
Secondary Outcome Measures
rate of successful ventilator weaning
percentage
diaphragm muscle thickness
mm
diaphragm thickening fraction
percentage
diaphragm excursion
mm
rate of death
percentage
Full Information
NCT ID
NCT04816201
First Posted
March 23, 2021
Last Updated
July 17, 2023
Sponsor
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04816201
Brief Title
Electroacupuncture to Assist Ventilator Weaning in Severe Stroke
Official Title
Electroacupuncture to Assist Ventilator Weaning in Severe Stroke: a Randomized, Sham-controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke
Detailed Description
Disuse atrophy of the major respiratory muscles and diaphragmatic dysfunction often develop during mechanical ventilation, and cause difficulties in ventilator weaning. Electroacupuncture was indicated to promote activities of diaphragm and improve diaphragmatic function. Our aim is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke. Sixties eligible patients will be randomly assigned to receive electroacupuncture or sham electroacupuncture treatment one session per day until the success of ventilator weaning (up to 21 days). The primay outcome is the ventilation duration within 21 days after enrollment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Stroke, Electroacupuncture
Keywords
ventilator weaning, severe stroke, electroacupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
Participants in the electroacupuncture group received acupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36). After skin disinfection, sterile adhesive pads were placed on these acupoints, and acupuncture needles were inserted through the adhesive pads approximately 50 to 60 mm into the skin. Paired electrodes from the electroacupuncture apparatus were attached to the needle handles of Xuanji (CV21) and Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), bilateral Liangmen (ST21), and bilateral Zusanli (ST36). The electroacupuncture stimulation lasted for 30 minutes with an intermittent wave of 50 Hz and a current intensity of 1 to 5mA (preferably with the skin around the acupoints shivering mildly without pain). Participants received 1 treatment session per day until the success of ventilator weaning (up to 21 days).
Arm Title
Sham electroacupuncture
Arm Type
Sham Comparator
Arm Description
Participants in the sham electroacupuncture group received sham electroacupuncture with a pragmatic placebo needle on sham acupoints. The sham Xuanji (CV21) point was 1 cun (≈20 mm) above to Xuanji (CV21), the sham Danzhong (CV27) point was 1 cun(≈20mm) above to Danzhong (CV27), the sham Qihai (CV06) point was 1 cun(≈20mm) above to Qihai (CV06), the sham Guanyuan (CV04) point was 1 cun(≈20mm) above to Guanyuan (CV04), the sham Liangmen (ST21) point was 1 cun(≈20mm) lateral to Liangmen (ST21), and the sham Zusanli (ST36) point was 1 cun(≈20mm) lateral to Zusanli (ST36). Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no skin penetration or electricity output.
Intervention Type
Other
Intervention Name(s)
Electroacupuncture
Intervention Description
Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).
Primary Outcome Measure Information:
Title
ventilation duration
Description
hours
Time Frame
within 21 days after enrollment
Secondary Outcome Measure Information:
Title
rate of successful ventilator weaning
Description
percentage
Time Frame
within 21 days after enrollment
Title
diaphragm muscle thickness
Description
mm
Time Frame
on day 7, day 14 and day 21
Title
diaphragm thickening fraction
Description
percentage
Time Frame
on day 7, day 14 and day 21
Title
diaphragm excursion
Description
mm
Time Frame
on day 7, day 14 and day 21
Title
rate of death
Description
percentage
Time Frame
within 21 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 years and ≤ 75 years ;
within 7 days after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain;
GCS on admission ≤ 12 or NIHSS on admission ≥ 11 or APACHEⅡ ≥ 15;
received mechanical ventilation;
written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.
Exclusion Criteria:
expected to be ventilated for < 24 h;
already ventilated for > 72 h;
GCS <5;
with unstable vital signs and requiring the use of vasoactive agents;
concomitant medical illness that would interfere with the outcome assessments and/or follow-up;
had spinal cord injury above T8 level, or lower motor neuron impairment, or neuromuscular junction impairment，or chest wall deformities, or chest wall injuries within 6 months, or chest or abdominal surgery within 4 week, or were pregnant;
had acute skin injury on the selected acupoints;
currently participating in other investigational trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Yuan, PhD
Phone
+86-20-81887233
Email
yuanfang@gzucm.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin Wang, PhD
Organizational Affiliation
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Yuan, PhD
Phone
+86-20-81887233
Email
plawlx@gzucm.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The detailed datasets used and/or analyzed during the current study are available upon reasonable request.
Citations:
PubMed Identifier
23720268
Citation
Tobin MJ, Laghi F, Jubran A. Ventilatory failure, ventilator support, and ventilator weaning. Compr Physiol. 2012 Oct;2(4):2871-921. doi: 10.1002/cphy.c110030.
Results Reference
background
PubMed Identifier
28698263
Citation
Kim WY, Lim CM. Ventilator-Induced Diaphragmatic Dysfunction: Diagnosis and Role of Pharmacological Agents. Respir Care. 2017 Nov;62(11):1485-1491. doi: 10.4187/respcare.05622. Epub 2017 Jul 11.
Results Reference
background
PubMed Identifier
28867413
Citation
Chen YJ, Hwang SL, Li CR, Yang CC, Huang KL, Lin CY, Lee CY. Vagal withdrawal and psychological distress during ventilator weaning and the related outcomes. J Psychosom Res. 2017 Oct;101:10-16. doi: 10.1016/j.jpsychores.2017.07.012. Epub 2017 Jul 29.
Results Reference
background
PubMed Identifier
32426748
Citation
Ataya A, Silverman EP, Bagchi A, Sarwal A, Criner GJ, McDonagh DL. Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1). Crit Care Explor. 2020 Apr 29;2(4):e0106. doi: 10.1097/CCE.0000000000000106. eCollection 2020 Apr.
Results Reference
background
PubMed Identifier
31107378
Citation
Essouri S, Baudin F, Mortamet G, Beck J, Jouvet P, Emeriaud G. Relationship Between Diaphragmatic Electrical Activity and Esophageal Pressure Monitoring in Children. Pediatr Crit Care Med. 2019 Jul;20(7):e319-e325. doi: 10.1097/PCC.0000000000001981.
Results Reference
background
PubMed Identifier
30904733
Citation
Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.
Results Reference
background
PubMed Identifier
30389829
Citation
Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176.
Results Reference
background
PubMed Identifier
31340846
Citation
McCaughey EJ, Jonkman AH, Boswell-Ruys CL, McBain RA, Bye EA, Hudson AL, Collins DW, Heunks LMA, McLachlan AJ, Gandevia SC, Butler JE. Abdominal functional electrical stimulation to assist ventilator weaning in critical illness: a double-blinded, randomised, sham-controlled pilot study. Crit Care. 2019 Jul 24;23(1):261. doi: 10.1186/s13054-019-2544-0.
Results Reference
background
PubMed Identifier
26047468
Citation
McCaughey EJ, Berry HR, McLean AN, Allan DB, Gollee H. Abdominal Functional Electrical Stimulation to Assist Ventilator Weaning in Acute Tetraplegia: A Cohort Study. PLoS One. 2015 Jun 5;10(6):e0128589. doi: 10.1371/journal.pone.0128589. eCollection 2015.
Results Reference
background
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Electroacupuncture to Assist Ventilator Weaning in Severe Stroke
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