Electroacupuncture to Assist Ventilator Weaning in Severe Stroke

Electroacupuncture Clinical Trial

Official title:

Electroacupuncture to Assist Ventilator Weaning in Severe Stroke: a Randomized, Sham-controlled Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816201
• Other study ID #: ZF2021-035
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: Fang Yuan, PhD
• Phone: +86-20-81887233
• Email: yuanfang[@]gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke

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. 100 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. age = 18 years and = 75 years ;

2. 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;

3. GCS on admission = 12 or NIHSS on admission = 11 or APACHE? = 15;

4. received mechanical ventilation;

5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations.

Exclusion Criteria:

1. expected to be ventilated for < 24 h;

2. already ventilated for > 72 h;

3. GCS <5;

4. with unstable vital signs and requiring the use of vasoactive agents;

5. concomitant medical illness that would interfere with the outcome assessments and/or follow-up;

6. 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;

7. had acute skin injury on the selected acupoints;

8. currently participating in other investigational trials.

Related Conditions & MeSH terms

• Electroacupuncture
• Severe Stroke
• Stroke

Intervention

Other:
• Electroacupuncture
Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilation duration	hours	within 21 days after enrollment
Secondary	rate of successful ventilator weaning	percentage	within 21 days after enrollment
Secondary	diaphragm muscle thickness	mm	on day 7, day 14 and day 21
Secondary	diaphragm thickening fraction	percentage	on day 7, day 14 and day 21
Secondary	diaphragm excursion	mm	on day 7, day 14 and day 21
Secondary	rate of death	percentage	within 21 days after enrollment