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

NCT05953649 | Unknown DMC

• 1 other identifier: SYSKY-2023-376-02
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Early Mobilization; Critically Ill; Mechanical Ventilation; Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 4 and Day 7.

Secondary Outcomes (9)

• Change from Baseline on Ventilation mode at Day 4 and Day 7.

  Baseline, Day 4 and Day 7.

• Change from Baseline on Positive End-expiratory Pressure (PEEP) at Day 4 and Day 7.

  Baseline, Day 4 and Day 7.

• Change from Baseline on minute ventilation at Day 4 and Day 7.

  Baseline, Day 4 and Day 7.

• Change from Baseline on tidal volume at Day 4 and Day 7.

  Baseline, Day 4 and Day 7.

• Change from Baseline on Maximum Inspiratory Pressure (MIP） at Day 4 and Day 7.

  Baseline, Day 4 and Day 7.

Other Outcomes (6)

• Day 28 mortality

  within 28 days of the finishing of the trial.

• ventilator free days

  within 28 days of the start of the trial

• Length of stay in ICU

  up to 28 days.

Study Arms (3)

Control group

ACTIVE COMPARATOR

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

Other: Conventional Physiotherapy

experimental group 1

EXPERIMENTAL

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

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.

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

Interventions

Extracorporeal Diaphragm Pacing DEVICE

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.

Also known as: External Diaphragm Pacing

experimental group 1; experimental group 2

Tilt Table Verticalization DEVICE

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.

Also known as: Tilt Table Standing, head-up tilt

experimental group 2

Conventional Physiotherapy OTHER

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.

Control group; experimental group 1; experimental group 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

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MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhijie He

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Zhijie He

CONTACT

011-86-13710898290; hezhijie@mail.sysu.edu.cn

Fangyi Li

CONTACT

011-86-8615603056533; Lify8@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 20, 2023
• Study Start: August 1, 2023
• Primary Completion: May 27, 2024
• Study Completion: July 27, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-05