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The aim of this study is to test the effect of 1week of extracorporeal diaphragm pacing (EDP) combined either with or without tilt table verticalization (TTV) on diaphragm function in patients with mechanical ventilation compared to conventional physiotherapy (CPT).
In order to explore whether extracorporeal diaphragm pacing (EDP) combined with tilt table verticalization (TTV) improves diaphragm function in mechanically ventilated patients, the investigators conducted a three-arms randomized controlled trial of 90 ventilated patients in the ICU of a general hospital in the southern China state of Guangzhou. After assessment of inclusion and exclusion criteria, patients were randomly assigned to one of the following three groups: (1) EDP with TTV and with conventional physiotherapy (CPT) (n = 30), (2) EDP without TTV and with CPT (n = 30), and (3) conventional physiotherapy (CPT; n = 30).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | In the control condition, patients received conventional physiotherapy (CPT) according to standard clinic procedures. |
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| experimental group 1 | Experimental | the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group. |
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| experimental group 2 | Experimental | the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Diaphragm Pacing | Device | In the EDP group, a pacer using the extracorporeal diaphragm pacemaker provided by Guangzhou Xueliang Biotechnology Developing Co., Ltd., the pacing electrode is pasted on the body surface closest to the phrenic nerve at the outer edge of the lower end of the sternocleidomastoid muscle under ultrasound guidance, and the auxiliary electrode is placed between the second intercostal of the midline of the clavicle. The intensity of treatment parameters was set from low to high, and the intensity of treatment was increased when the patient could tolerate it, pacing 12-18 times/min at a frequency of 40 hertz (Hz)/30min/time, and performed every 12 hours for a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7. | The Diaphragm thickening fraction-DTf (%) was calculated as the difference between end-expiration and end-inspiration divided by end-inspiration × 100.Diaphragm thickening fraction (DTf) less than 20% is a measure of ultrasonographic diaphragmatic dysfunction in patients on mechanical ventilation. | Baseline, Day 4 and Day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline on Ventilation mode at Day 4 and Day 7. | A ventilator mode is a way of describing how the mechanical ventilator assists the patient with taking a breath. | Baseline, Day 4 and Day 7. |
| Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Day 28 mortality | Short-term mortality was defined as a date of all-cause death within 28 days of the finishing of the trial. | within 28 days of the finishing of the trial. |
| ventilator free days | It is defined as a date of no ventilation within 28 days of the start of the trial. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijie He | Contact | 011-86-13710898290 | hezhijie@mail.sysu.edu.cn | |
| Fangyi Li | Contact | 011-86-8615603056533 | Lify8@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhijie He | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27030815 | Background | Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9. | |
| 20046120 | Background | Powers SK, Kavazis AN, Levine S. Prolonged mechanical ventilation alters diaphragmatic structure and function. Crit Care Med. 2009 Oct;37(10 Suppl):S347-53. doi: 10.1097/CCM.0b013e3181b6e760. |
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| Tilt Table Verticalization | Device | VitalGo bed (VitalGo Systems Ltd., Fort Lauderdale） is used for verticalization. Verticalization was set to minimum 30°, depending on cardiopulmonary parameters (respiratory rate, heart rate, blood pressure, oxygen saturation), vertical position was gradually increased (in 5° steps) to a maximum of 90°, as long as the above-named cardiopulmonary parameters of the patient remained stable and remain this position for 30 minutes simultaneously with extracorporeal diaphragm pacing for a week. |
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| Conventional Physiotherapy | Other | Patients receive early mobilization, which refers to a series of clinical intervention protocols (such as passive movement or active exercises, etc.) that confers physical benefits at an early period in collaboration with a multidisciplinary team (intensive care physicians, rehabilitation physicians, physical therapists, occupational therapists, respiratory therapists, and nurses). The study intervention take place during working time between 8 a.m. and 17 p.m. Patients of all three study groups receive this rehabilitation program until they transfer out of ICU. |
|
Positive end-expiratory pressure (PEEP) is the positive pressure that will remain in the airways at the end of the respiratory cycle (end of exhalation) that is greater than the atmospheric pressure in mechanically ventilated patients. |
| Baseline, Day 4 and Day 7. |
| Change from Baseline on minute ventilation at Day 4 and Day 7. | It usually refers to the expired amount and can be calculated using the following equation: minute ventilation (VE)= tidal volume (VT) ×respiratory frequency(f) | Baseline, Day 4 and Day 7. |
| Change from Baseline on tidal volume at Day 4 and Day 7. | Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle. | Baseline, Day 4 and Day 7. |
| Change from Baseline on Maximum Inspiratory Pressure (MIP） at Day 4 and Day 7. | The maximum inspiratory pressures measure the maximal efforts of the respiratory muscles. | Baseline, Day 4 and Day 7. |
| Change from Baseline on airway occlusion pressure (P0.1) at Day 4 and Day 7. | P0.1 is a parameter for the neuro-muscular activation of the respiratory system, which is an important determinant for the work of breathing. | Baseline, Day 4 and Day 7. |
| Change from Baseline on transdiaphragmatic pressure at Day 4 and Day 7. | Transdiaphragmatic pressure (Pdi) represents the pressure across the diaphragm, which can be expressed as the difference between abdominal pressure (Pab) and pleural pressure (Ppl):Pdi = Ppl- Pab. | Baseline, Day 4 and Day 7. |
| Change from Baseline on MRC score at Day 4 and Day 7. | Medical Research Council (MRC)-sum score evaluates global muscle strength. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using MRC scale. Summation of scores gives MRC-sum score, ranging from 0 to 60. | Baseline, Day 4 and Day 7. |
| Change from Baseline on Blood oxygen status at Day 4 and Day 7. | Oxygenation Index = (FiO2× Mean Airway Pressure) / partial pressure of oxygen in arterial blood (PaO2) The oxygenation index is used to assess the intensity of ventilatory support required to maintain oxygenation. | Baseline, Day 4 and Day 7. |
| within 28 days of the start of the trial |
| Length of stay in ICU | The patient's length of stay in the ICU since the beginning of inclusion. | up to 28 days. |
| Ratio of short weaning | It is defined as the first separation attempt resulted in a termination of the weaning process within 24 hours (successful separation or early death). | within 28 days of the start of the trial |
| Duration of control ventilation | It is defined as the ventilation mode in which the frequency, tidal volume, and inspiratory time of breathing are controlled by a ventilator because the patient has no spontaneous breathing or very weak spontaneous breathing. | within 28 days of the start of the trial |
| Duration of ventilation | It is defined as a date of ventilation within 28 days of the start of the trial. | within 28 days of the start of the trial |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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