Effects of phrenic nerve electrical stimulation on diaphragm function and weaning outcomes
| ISRCTN | ISRCTN17616237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17616237 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 20200200106-11 |
| Sponsor | Sir Run Run Shaw Hospital |
| Funder | Sir Run Run Shaw Hospital |
- Submission date
- 20/06/2021
- Registration date
- 02/07/2021
- Last edited
- 25/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
The diaphragm is the main respiratory (breathing) muscle and plays an important role in ventilation, airway clearance and speech. Mechanical ventilation is a form of life support where a machine takes over the work of breathing when a person is not able to breathe enough on their own. As ICU patients on mechanical ventilation can rapidly develop diaphragmatic weakness, strategies to improve diaphragmatic function are urgently needed. Currently, no drugs have been proven to improve diaphragm function. External diaphragm pacing (EDP) may be a non-invasive treatment, especially for critically patients who are susceptible to diaphragmatic weakness. EDP is inexpensive and easy to operate, and has been used in patients with other diseases. The aim of this study is to find out whether early intervention with EDP in mechanically ventilated patients with mechanical ventilation improves diaphragm function.
Who can participate?
Patients over 18 years old with acute respiratory failure requiring invasive mechanical ventilation
What does the study involve?
Participants will be randomly allocated to receive sham treatment or EDP treatment. Treatment will begin at the time of enrolment of patients until they are weaned from mechanical ventilation. The maximum follow-up is 28 days.
What are the possible benefits and risks of participating?
The patient's condition may improve and this study may help develop a new treatment for other mechanically ventilated patients. Sputum discharge may increase during treatment. If it is not discharged in time, it may increase the risk of aspiration. The researchers will pay close attention to and timely aspirate sputum for patients during treatment. In addition, when the EDP intensity is too high the patient may experience discomfort, and the researchers will continuously help to adjust the intensity to help the patient feel comfortable.
Where is the study run from?
Sir Run Run Shaw Hospital affiliated to the Medical College of Zhejiang University (China)
When is the study starting and how long is it expected to run for?
January 2020 to December 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Ding Yuejia
ding_yuejia@zju.edu.cn
Contact information
Public
3 Qingchun East Road
Jianggan District
HangZhou
310016
China
| Phone | +86 (0)18268113280 |
|---|---|
| ding_yuejia@zju.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | External phrenic nerve pacing to preserve diaphragm function and improve weaning outcomes: a feasibility study |
| Study objectives | Early intervention with EDP in severe mechanical ventilated patients can improve their diaphragm function and weaning outcomes, and EDP is feasible for patients with severe mechanical ventilation. |
| Ethics approval(s) | Approved 01/06/2020, Medical Ethics Committee of Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine (3 Qingchun East Road, Jianggan District, Hangzhou; +86 (0)57186006811; xumingsrrsh@foxmail.com), ref: 20200106-11 |
| Health condition(s) or problem(s) studied | Patients with acute respiratory failure requiring invasive mechanical ventilation |
| Intervention | After the candidates or their family members sign the informed consent, the research staff contacts the liaison of the lead center for central randomization by specially assigned staff. Sham treatment group: ICU standard care is prescribed by the attending physician according to the relevant program/guideline. For EDP treatment, the stimulation intensity will be set to 1 unit (no obvious contraction of the diaphragm). Treatment group: EDP treatment will be performed on the basis of ICU standard care (30 minutes, twice a day, 7 days a week). The small electrode pieces are placed in the outer edge of the sternocleidomastoid muscle, at the lower 1/3 junction (flat cartilage level), and the large electrode piece is placed at the inner edge of the midclavicular line and the second intercostal space. Set parameters (pulse frequency: 40 Hz, pacing times: 9 times/minute, if the EDP and the patient's breathing are not synchronized, adjust the pacing times). The intensity of the stimulus gradually increases from 0 to the maximum intensity that the patient can tolerate. Awakened patients can respond to intensity while sedated patients need to assess whether the intensity is appropriate based on facial expressions, physical movements, blood pressure, and heart rate. Painful facial expressions include frowning, brow reduction, tight eyelids, contraction of the diaphragm and closure of the eyelids; painful movements of the body may be slow, cautious movement, touching the pain, and seeking attention through movement. For patients with internal jugular vein catheterization, if the electrode piece is too close to the puncture point, the electrode piece is cut to ensure a distance of 1 cm away from the puncture point. Another option is unilateral stimulation. Treatment will begin at the time of enrolment of patients until they are weaned. The maximum follow-up is 28 days. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Enrollment rate: number of enrolled patients divided by total number of patients meeting the criteria of this study at 48 hours after the establishment of an artificial airway |
| Key secondary outcome measure(s) |
1. Diaphragm thickness: at the end of exhalation and inspiration the thickness of the right diaphragm will be measured using diaphragm ultrasound during tidal breathing to calculate the muscle thickening score. Measured at baseline, every other day, for the first SBT (under EDP) and on day 28 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Patients with acute respiratory failure requiring invasive mechanical ventilation *Incorporated within 48 hours after the establishment of the artificial airway 2. Estimated mechanical ventilation time >72 hours 3. Aged over 18 years old |
| Key exclusion criteria | 1. Pneumothorax or mediastinal emphysema 2. Acute myocarditis, severe arrhythmia 3. Neuromuscular diseases that may affect weaning, including myasthenia gravis, motor neuron disease, and congenital myopathy 4. Hemodynamic instability (mean arterial pressure <60 mmHg and norepinephrine >0.2 ug/kg/min) 5. Paroxysmal sympathetic hyperactivity syndrome 6. Even chest 7. Pregnancy 8. Fitted with a pacemaker/implantable defibrillator 9. Applying neuromuscular blockers (NMBAs) within the past 6 hours 10. History of neck radiation therapy or neck surgery 11. Cancer of the neck and lung 12. Unable to obtain accurate diaphragm ultrasound results |
| Date of first enrolment | 01/07/2020 |
| Date of final enrolment | 01/12/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Jianggan District
HangZhou
310016
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from ding_yuejia@zju.edu.cn after article publication. The data will be available beginning 9 months and ending 36 months following article publication. Anyone with any purpose who wishes to access the data is OK. Consent from participants was obtained and the data is anonymous. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/06/2021: Trial's existence confirmed by Medical Ethics Committee of Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine.
