Respiratory Insufficiency Requiring Mechanical VentilationNCT05217511
Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
A study testing Neuromuscular Electrical Stimulation in people with Respiratory Insufficiency Requiring Mechanical Ventilation, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems… 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?
- Neuromuscular Electrical Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Aug 2022
- 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 MV(>72 h);
- Written informed consent was obtained from the patients or their relatives
Who cannot join
- Previous neuromuscular disease;
- Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
- Thoracic or diaphragmatic malformation;
- Local skin damage and infection;
- Indwelling a temporary or permanent pacemaker;
- Severe obesity(BMI>35 kg/m2)
- Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement;
- Patients with an expected survival time of less than 7 days or with palliative care
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Neuromuscular electrical stimulation
Qingdao, 266003
Zehua Dong, Dr., 18661803112, liuyingwallace@163.com
About this study
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. 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.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.
- Being tested
- Neuromuscular Electrical Stimulation
- Keywords
- Diaphragm ultrasound, Intercostal muscle ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Electrical StimulationBehavioural
NMES was performed using a portable machine.The negative electrodes were placed in the motor points of the following muscles: chest muscles (pectoralis major muscle fibres) and rectus abdominis muscles bilaterally. A second (positive) electrode was positioned distally to the first, at a site close to the muscle that was being electrically stimulated, totalling 1 channel with 2 electrodes for each muscle . Each NMES session lasted 30 min. The following parameters were used: 50 Hz frequency, pulse duration 300 ms, rise time 1 s, stimulus time (ON) 3 s, decay time 1 s, and relaxation time (OFF) 10 s. Intensity was increased until muscle contraction was visible or could be identified through palpation. In conscious patients, intensity was adjusted according to their tolerance.
| Study group | Role | What they receive |
|---|---|---|
| NMSE Group | Experimental | Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU. Receives: Behavioral: Neuromuscular Electrical Stimulation |
| CPT group | No intervention | The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%. Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value
Measured: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Secondary outcomes (1)
Parasternal Intercostal Muscle Ultrasound
A 10- to 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 posted1 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (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
- 47 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
- NCT05217511
- Sponsor's protocol ID
- DZH20220104
- Status last verified
- Feb 2022
- First submitted
- 8 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05217511
- Acronym / sponsor ID
- DZH20220104
- Keywords
- Diaphragm ultrasound, Intercostal muscle ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 1 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.
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. 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.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMSE Group | Experimental | Behavioral: Neuromuscular Electrical StimulationNeuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU. |
| CPT group | No intervention | –The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prolonged MV(>72 h);
- Written informed consent was obtained from the patients or their relatives
Key exclusion criteria (8 listed)
- Previous neuromuscular disease;
- Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
- Thoracic or diaphragmatic malformation;
- Local skin damage and infection;
- Indwelling a temporary or permanent pacemaker;
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 |
|---|---|---|
| Neuromuscular Electrical StimulationNMES was performed using a portable machine.The negative electrodes were placed in the motor points of the following muscles: chest muscles (pectoralis major muscle fibres) and rectus abdominis muscles bilaterally. A second (positive) electrode was positioned distally to the first, at a site close to the muscle that was being electrically stimulated, totalling 1 channel with 2 electrodes for each muscle . Each NMES session lasted 30 min. The following parameters were used: 50 Hz frequency, pulse duration 300 ms, rise time 1 s, stimulus time (ON) 3 s, decay time 1 s, and relaxation time (OFF) 10 s. Intensity was increased until muscle contraction was visible or could be identified through palpation. In conscious patients, intensity was adjusted according to their tolerance. | Behavioural | NMSE Group |
Primary outcome
diaphragmatic thickening fraction(DTF)
Time frame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
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%. Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value
1 secondary outcome
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 2 Mar 2022.
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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 Neuromuscular Electrical Stimulation 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 2 inclusion and 8 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 2 Mar 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?
diaphragmatic thickening fraction(DTF) (time frame: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation). 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 2 Mar 2022.