Early MobilizationNCT05953649
Effect of Early Extracorporeal Diaphragm Pacing Combined With Tilt Table in Ventilated Patients.
A study testing Extracorporeal Diaphragm Pacing, Tilt Table Verticalization and Conventional Physiotherapy in people with Early Mobilization and Critically Ill, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Early Mobilization, Critically Ill, Mechanical Ventilation
- What is being tested?
- Extracorporeal Diaphragm Pacing, Tilt Table Verticalization and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 27 Jul 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of mechanical ventilation prior to enrollment≤ 72 hours.
- Expected duration of mechanical ventilation≥72 hours.
- Participants (or their legal representatives) have signed informed consent.
Who cannot join
- Pregnancy or breast-feeding.
- Prone ventilation or current extracorporeal membrane oxygenation.
- Hemodynamic instability: mean arterial pressure is less than 65 millimeters of mercury (mmHg) or higher than 85 millimeters of mercury (mmHg), heart rate > 150 beats / minute, intravenous use of larger doses of vasopressors (such as dopamine > 10 mg/ (kg· min) or norepinephrine/epinephrine >0.1 mg/ (kg· min)) or aortic balloon counter pulsation; respiratory rate< 5 breaths per minute; Oxygen saturation< 88%.
- New-onset myocardial ischemia.
- Unstable cervical spine fracture and spinal cord injury.
- Deterioration of neurological function, requiring intracranial pressure monitoring and ventricular drainage, or active control of intracranial hypertension.
Show all 12Show fewer
- Current neuromuscular block treatment or pre-existing neuromuscular disease or neuromuscular junction disease affecting respiratory muscle (such as myasthenia gravis, Guillain-Barré syndrome, etc.).
- There are contraindications to diaphragmatic pacing (local skin, tissue incompleteness or infection, chest X-ray examination shows pneumothorax or pleural effusion accounting for 1/3 of bilateral chest cavity).
- Body mass index (BMI) ⩾40 kg/m2.
- Known / suspected phrenic nerve palsy.
- Patients who refuse active treatment or are in the terminal stage of malignant tumors, have an expected life expectancy of < 6 months, etc.
- Participated in other clinical studies related to mechanical ventilation within 2 months prior to the start of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Early Extracorporeal Diaphragm Pacing （EDP） Combined With Tilt Table Verticalization （TTV) on Diaphragm Function in Critically Ill Patients With Mechanical Ventilation: a Randomized Controlled Trial.
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).
Read the detailed description
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).
- Being tested
- Extracorporeal Diaphragm Pacing, Tilt Table Verticalization, Conventional Physiotherapy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Diaphragm PacingDevice
Also called External Diaphragm Pacing
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.
Tilt Table VerticalizationDevice
Also called Tilt Table Standing, head-up tilt
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.
Conventional PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | In the control condition, patients received conventional physiotherapy (CPT) according to standard clinic procedures. Receives: Other: Conventional Physiotherapy |
| experimental group 1 | Experimental | the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group. Receives: Device: Extracorporeal Diaphragm Pacing; Other: Conventional Physiotherapy |
| 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. Receives: Device: Extracorporeal Diaphragm Pacing; Device: Tilt Table Verticalization; Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 4 and Day 7.
Secondary outcomes (9)
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.
Measured: Baseline, Day 4 and Day 7.
Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 4 and Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion27 May 2024 (estimated)
- Study completion27 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Early MobilizationStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijie He, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953649
- Sponsor's protocol ID
- SYSKY-2023-376-02
- Status last verified
- May 2023
- First submitted
- 12 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27030815Powers 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.
PubMed 20046120Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
PubMed 23786764Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
PubMed 27310484Zergeroglu MA, McKenzie MJ, Shanely RA, Van Gammeren D, DeRuisseau KC, Powers SK. Mechanical ventilation-induced oxidative stress in the diaphragm. J Appl Physiol (1985). 2003 Sep;95(3):1116-24. doi: 10.1152/japplphysiol.00824.2002. Epub 2003 May 30.
PubMed 12777408Maes K, Stamiris A, Thomas D, Cielen N, Smuder A, Powers SK, Leite FS, Hermans G, Decramer M, Hussain SN, Gayan-Ramirez G. Effects of controlled mechanical ventilation on sepsis-induced diaphragm dysfunction in rats. Crit Care Med. 2014 Dec;42(12):e772-82. doi: 10.1097/CCM.0000000000000685.
PubMed 25402297Powers SK, Hudson MB, Nelson WB, Talbert EE, Min K, Szeto HH, Kavazis AN, Smuder AJ. Mitochondria-targeted antioxidants protect against mechanical ventilation-induced diaphragm weakness. Crit Care Med. 2011 Jul;39(7):1749-59. doi: 10.1097/CCM.0b013e3182190b62.
PubMed 21460706Tang H, Shrager JB. The Signaling Network Resulting in Ventilator-induced Diaphragm Dysfunction. Am J Respir Cell Mol Biol. 2018 Oct;59(4):417-427. doi: 10.1165/rcmb.2018-0022TR.
PubMed 29768017Dridi H, Yehya M, Barsotti R, Reiken S, Angebault C, Jung B, Jaber S, Marks AR, Lacampagne A, Matecki S. Mitochondrial oxidative stress induces leaky ryanodine receptor during mechanical ventilation. Free Radic Biol Med. 2020 Jan;146:383-391. doi: 10.1016/j.freeradbiomed.2019.11.019. Epub 2019 Nov 19.
PubMed 31756525van den Berg M, Hooijman PE, Beishuizen A, de Waard MC, Paul MA, Hartemink KJ, van Hees HWH, Lawlor MW, Brocca L, Bottinelli R, Pellegrino MA, Stienen GJM, Heunks LMA, Wust RCI, Ottenheijm CAC. Diaphragm Atrophy and Weakness in the Absence of Mitochondrial Dysfunction in the Critically Ill. Am J Respir Crit Care Med. 2017 Dec 15;196(12):1544-1558. doi: 10.1164/rccm.201703-0501OC.
PubMed 28787181Aslan GK, Huseyinsinoglu BE, Oflazer P, Gurses N, Kiyan E. Inspiratory Muscle Training in Late-Onset Pompe Disease: The Effects on Pulmonary Function Tests, Quality of Life, and Sleep Quality. Lung. 2016 Aug;194(4):555-61. doi: 10.1007/s00408-016-9881-4. Epub 2016 Apr 22.
PubMed 27106274Vorona S, Sabatini U, Al-Maqbali S, Bertoni M, Dres M, Bissett B, Van Haren F, Martin AD, Urrea C, Brace D, Parotto M, Herridge MS, Adhikari NKJ, Fan E, Melo LT, Reid WD, Brochard LJ, Ferguson ND, Goligher EC. Inspiratory Muscle Rehabilitation in Critically Ill Adults. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Jun;15(6):735-744. doi: 10.1513/AnnalsATS.201712-961OC.
PubMed 29584447Hearn E, Gosselink R, Freene N, Boden I, Green M, Bissett B. Inspiratory muscle training in intensive care unit patients: An international cross-sectional survey of physiotherapist practice. Aust Crit Care. 2022 Sep;35(5):527-534. doi: 10.1016/j.aucc.2021.08.002. Epub 2021 Sep 8.
PubMed 34507849Dres M, de Abreu MG, Merdji H, Muller-Redetzky H, Dellweg D, Randerath WJ, Mortaza S, Jung B, Bruells C, Moerer O, Scharffenberg M, Jaber S, Besset S, Bitter T, Geise A, Heine A, Malfertheiner MV, Kortgen A, Benzaquen J, Nelson T, Uhrig A, Moenig O, Meziani F, Demoule A, Similowski T; RESCUE-2 Study Group Investigators. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients. Am J Respir Crit Care Med. 2022 May 15;205(10):1169-1178. doi: 10.1164/rccm.202107-1709OC.
PubMed 35108175
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Extracorporeal Diaphragm Pacing （EDP） Combined With Tilt Table Verticalization （TTV) on Diaphragm Function in Critically Ill Patients With Mechanical Ventilation: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05953649
- Acronym / sponsor ID
- SYSKY-2023-376-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 27 May 2024 (estimated)
- Study completion
- 27 Jul 2024 (estimated)
- First posted
- 20 Jul 2023 (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.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventional PhysiotherapyIn the control condition, patients received conventional physiotherapy (CPT) according to standard clinic procedures. |
| experimental group 1 | Experimental | Device: Extracorporeal Diaphragm Pacing, Other: Conventional Physiotherapythe experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group. |
| experimental group 2 | Experimental | Device: Extracorporeal Diaphragm Pacing, Device: Tilt Table Verticalization, Other: Conventional Physiotherapythe experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duration of mechanical ventilation prior to enrollment≤ 72 hours.
- Expected duration of mechanical ventilation≥72 hours.
- Participants (or their legal representatives) have signed informed consent.
Key exclusion criteria (12 listed)
- Pregnancy or breast-feeding.
- Prone ventilation or current extracorporeal membrane oxygenation.
- Hemodynamic instability: mean arterial pressure is less than 65 millimeters of mercury (mmHg) or higher than 85 millimeters of mercury (mmHg), heart rate > 150 beats / minute, intravenous use of larger doses of vasopressors (such as dopamine > 10 mg/ (kg· min) or norepinephrine/epinephrine >0.1 mg/ (kg· min)) or aortic balloon counter pulsation; respiratory rate< 5 breaths per minute; Oxygen saturation< 88%.
- New-onset myocardial ischemia.
- Unstable cervical spine fracture and spinal cord injury.
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 |
|---|---|---|
| Extracorporeal Diaphragm PacingAlso: External Diaphragm PacingIn 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. | Device | experimental group 1, experimental group 2 |
| Tilt Table VerticalizationAlso: Tilt Table Standing, head-up tiltVitalGo 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. | Device | experimental group 2 |
| Conventional PhysiotherapyPatients 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. | Other | Control group, experimental group 1, experimental group 2 |
Primary outcome
Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7.
Time frame: Baseline, 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.
9 secondary outcomes
Change from Baseline on Ventilation mode at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on minute ventilation at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on tidal volume at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on Maximum Inspiratory Pressure (MIP） at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on airway occlusion pressure (P0.1) at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on transdiaphragmatic pressure at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on MRC score at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Change from Baseline on Blood oxygen status at Day 4 and Day 7.
Time frame: Baseline, Day 4 and Day 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 27030815Berger 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.
- Background: PubMed 20046120Powers 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.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Background: PubMed 23786764Supinski GS, Callahan LA. Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.
- Background: PubMed 27310484Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
- Background: PubMed 12777408Zergeroglu MA, McKenzie MJ, Shanely RA, Van Gammeren D, DeRuisseau KC, Powers SK. Mechanical ventilation-induced oxidative stress in the diaphragm. J Appl Physiol (1985). 2003 Sep;95(3):1116-24. doi: 10.1152/japplphysiol.00824.2002. Epub 2003 May 30.
- Background: PubMed 25402297Maes K, Stamiris A, Thomas D, Cielen N, Smuder A, Powers SK, Leite FS, Hermans G, Decramer M, Hussain SN, Gayan-Ramirez G. Effects of controlled mechanical ventilation on sepsis-induced diaphragm dysfunction in rats. Crit Care Med. 2014 Dec;42(12):e772-82. doi: 10.1097/CCM.0000000000000685.
- Background: PubMed 21460706Powers SK, Hudson MB, Nelson WB, Talbert EE, Min K, Szeto HH, Kavazis AN, Smuder AJ. Mitochondria-targeted antioxidants protect against mechanical ventilation-induced diaphragm weakness. Crit Care Med. 2011 Jul;39(7):1749-59. doi: 10.1097/CCM.0b013e3182190b62.
- Background: PubMed 29768017Tang H, Shrager JB. The Signaling Network Resulting in Ventilator-induced Diaphragm Dysfunction. Am J Respir Cell Mol Biol. 2018 Oct;59(4):417-427. doi: 10.1165/rcmb.2018-0022TR.
- Background: PubMed 31756525Dridi H, Yehya M, Barsotti R, Reiken S, Angebault C, Jung B, Jaber S, Marks AR, Lacampagne A, Matecki S. Mitochondrial oxidative stress induces leaky ryanodine receptor during mechanical ventilation. Free Radic Biol Med. 2020 Jan;146:383-391. doi: 10.1016/j.freeradbiomed.2019.11.019. Epub 2019 Nov 19.
- Background: PubMed 28787181van den Berg M, Hooijman PE, Beishuizen A, de Waard MC, Paul MA, Hartemink KJ, van Hees HWH, Lawlor MW, Brocca L, Bottinelli R, Pellegrino MA, Stienen GJM, Heunks LMA, Wust RCI, Ottenheijm CAC. Diaphragm Atrophy and Weakness in the Absence of Mitochondrial Dysfunction in the Critically Ill. Am J Respir Crit Care Med. 2017 Dec 15;196(12):1544-1558. doi: 10.1164/rccm.201703-0501OC.
- Background: PubMed 27106274Aslan GK, Huseyinsinoglu BE, Oflazer P, Gurses N, Kiyan E. Inspiratory Muscle Training in Late-Onset Pompe Disease: The Effects on Pulmonary Function Tests, Quality of Life, and Sleep Quality. Lung. 2016 Aug;194(4):555-61. doi: 10.1007/s00408-016-9881-4. Epub 2016 Apr 22.
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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.
Zhijie He study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Diaphragm Pacing, Tilt Table Verticalization and Conventional Physiotherapy in people with Early Mobilization and Critically Ill, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 3 inclusion and 12 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Zhijie He (011-86-13710898290, hezhijie@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7. (time frame: Baseline, Day 4 and Day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953649, which also lists 29 linked publications.
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 20 Jul 2023.