Clinical trial NCT05953649: Effect of Early Extracorporeal Diaphragm Pacing Combined With Tilt Table in Ventilated Patients.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Mobilization
Critically Ill
Mechanical Ventilation
Diaphragm Dysfunction
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
Secondary outcomes:
measure: Change from Baseline on Ventilation mode at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on minute ventilation at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on tidal volume at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on Maximum Inspiratory Pressure (MIP） at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on airway occlusion pressure (P0.1) at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on transdiaphragmatic pressure at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on MRC score at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
measure: Change from Baseline on Blood oxygen status at Day 4 and Day 7.
timeFrame: Baseline, Day 4 and Day 7.
Other outcomes:
measure: Day 28 mortality
timeFrame: within 28 days of the finishing of the trial.
measure: ventilator free days
timeFrame: within 28 days of the start of the trial
measure: Length of stay in ICU
timeFrame: up to 28 days.
measure: Ratio of short weaning
timeFrame: within 28 days of the start of the trial
measure: Duration of control ventilation
timeFrame: within 28 days of the start of the trial
measure: Duration of ventilation
timeFrame: within 28 days of the start of the trial
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Zhijie He
role: STUDY_DIRECTOR
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