Effect of Early Extracorporeal Diaphragm Pacing Combined With Tilt Table in Ventilated Patients.

Not Applicable

Not yet recruiting

• Conditions: Diaphragm Dysfunction; Early Mobilization; Critically Ill; Mechanical Ventilation
• Interventions: Device: Extracorporeal Diaphragm Pacing; Other: Conventional Physiotherapy; Device: Tilt Table Verticalization

• Registration Number: NCT05953649
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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).

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20
• Study Start: 2023-08-01
• Primary Completion: 2024-05-27
• Study Completion: 2024-07-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group 1	Extracorporeal Diaphragm Pacing	the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group.
Control group	Conventional Physiotherapy	In the control condition, patients received conventional physiotherapy (CPT) according to standard clinic procedures.
experimental group 2	Extracorporeal Diaphragm Pacing	the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.
experimental group 2	Conventional Physiotherapy	the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.
experimental group 2	Tilt Table Verticalization	the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.
experimental group 1	Conventional Physiotherapy	the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group.

Primary Outcome Measures

Name	Time	Method
Change from Baseline on Diaphragm Thickening Fraction at Day 4 and Day 7.	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline on transdiaphragmatic pressure at Day 4 and Day 7.	Baseline, 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.
Change from Baseline on minute ventilation at Day 4 and Day 7.	Baseline, 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)
Change from Baseline on tidal volume at Day 4 and Day 7.	Baseline, Day 4 and Day 7.	Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.
Change from Baseline on Maximum Inspiratory Pressure (MIP） at Day 4 and Day 7.	Baseline, Day 4 and Day 7.	The maximum inspiratory pressures measure the maximal efforts of the respiratory muscles.
Change from Baseline on Blood oxygen status at Day 4 and Day 7.	Baseline, 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.
Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7.	Baseline, 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.
Change from Baseline on Ventilation mode at Day 4 and Day 7.	Baseline, Day 4 and Day 7.	A ventilator mode is a way of describing how the mechanical ventilator assists the patient with taking a breath.
Change from Baseline on airway occlusion pressure (P0.1) at Day 4 and Day 7.	Baseline, 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.
Change from Baseline on MRC score at Day 4 and Day 7.	Baseline, 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.