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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Critically Ill; Early Mobilization; Mechanical Ventilation; Diaphragm Dysfunction

Treatments: Other: Conventional Physiotherapy; Device: Tilt Table Verticalization; Device: Extracorporeal Diaphragm Pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT05953649

SYSKY-2023-376-02

Details and patient eligibility

About

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).

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control group

Active Comparator group

Description:

In the control condition, patients received conventional physiotherapy (CPT) according to standard clinic procedures.

Treatment:

Other: Conventional Physiotherapy

experimental group 1

Experimental group

Description:

the experimental group uses Extracorporeal Diaphragm Pacing (EDP) on the basis of the control group.

Treatment:

Other: Conventional Physiotherapy

Device: Extracorporeal Diaphragm Pacing

experimental group 2

Experimental group

Description:

the experimental group used Extracorporeal Diaphragm Pacing (EDP) combined with Tilt Table Verticalization (TTV) on the basis of the control group.

Treatment:

Other: Conventional Physiotherapy

Device: Extracorporeal Diaphragm Pacing

Device: Tilt Table Verticalization