NCT05953649

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Early Mobilization
• Critically Ill
• Mechanical Ventilation
• Diaphragm Dysfunction

Interventions

Type	Name	Description
DEVICE	Extracorporeal 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.
DEVICE	Tilt Table Verticalization	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.
OTHER	Conventional Physiotherapy	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-05-27
• Completion: 2024-07-27
• First posted: 2023-07-20
• Last updated: 2023-07-20