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

Primary Purpose

Early Mobilization, Critically Ill, Mechanical Ventilation

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Extracorporeal Diaphragm Pacing

Tilt Table Verticalization

Conventional Physiotherapy

About this trial

This is an interventional treatment trial for Early Mobilization

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control group

experimental group 1

experimental group 2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline on Ventilation mode at 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 Positive End-expiratory Pressure (PEEP) at 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 minute ventilation at 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.

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.

The maximum inspiratory pressures measure the maximal efforts of the respiratory muscles.

Change from Baseline on airway occlusion pressure (P0.1) at 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 transdiaphragmatic pressure at 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 MRC score at 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.

Change from Baseline on Blood oxygen status at 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.

Full Information

NCT ID

NCT05953649

First Posted

June 12, 2023

Last Updated

July 12, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT05953649

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

May 27, 2024 (Anticipated)

Study Completion Date

July 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Mobilization, Critically Ill, Mechanical Ventilation, Diaphragm Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Arm Title

experimental group 1

Arm Type

Experimental

Arm Description

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

Arm Title

experimental group 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Extracorporeal Diaphragm Pacing

Other Intervention Name(s)

External Diaphragm Pacing

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Tilt Table Verticalization

Other Intervention Name(s)

Tilt Table Standing, head-up tilt

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional Physiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Day 4 and Day 7.

Secondary Outcome Measure Information:

Title

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

Description

A ventilator mode is a way of describing how the mechanical ventilator assists the patient with taking a breath.

Time Frame

Baseline, Day 4 and Day 7.

Title

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

Description

Time Frame

Baseline, Day 4 and Day 7.

Title

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

Description

It usually refers to the expired amount and can be calculated using the following equation: minute ventilation (VE)= tidal volume (VT) ×respiratory frequency(f)

Time Frame

Baseline, Day 4 and Day 7.

Title

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

Description

Tidal volume is the amount of air that moves in or out of the lungs with each respiratory cycle.

Time Frame

Baseline, Day 4 and Day 7.

Title

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

Description

The maximum inspiratory pressures measure the maximal efforts of the respiratory muscles.

Time Frame

Baseline, Day 4 and Day 7.

Title

Change from Baseline on airway occlusion pressure (P0.1) at Day 4 and Day 7.

Description

P0.1 is a parameter for the neuro-muscular activation of the respiratory system, which is an important determinant for the work of breathing.

Time Frame

Baseline, Day 4 and Day 7.

Title

Change from Baseline on transdiaphragmatic pressure at Day 4 and Day 7.

Description

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.

Time Frame

Baseline, Day 4 and Day 7.

Title

Change from Baseline on MRC score at Day 4 and Day 7.

Description

Time Frame

Baseline, Day 4 and Day 7.

Title

Change from Baseline on Blood oxygen status at Day 4 and Day 7.

Description

Time Frame

Baseline, Day 4 and Day 7.

Other Pre-specified Outcome Measures:

Title

Day 28 mortality

Description

Short-term mortality was defined as a date of all-cause death within 28 days of the finishing of the trial.

Time Frame

within 28 days of the finishing of the trial.

Title

ventilator free days

Description

It is defined as a date of no ventilation within 28 days of the start of the trial.

Time Frame

within 28 days of the start of the trial

Title

Length of stay in ICU

Description

The patient's length of stay in the ICU since the beginning of inclusion.

Time Frame

up to 28 days.

Title

Ratio of short weaning

Description

It is defined as the first separation attempt resulted in a termination of the weaning process within 24 hours (successful separation or early death).

Time Frame

within 28 days of the start of the trial

Title

Duration of control ventilation

Description

It is defined as the ventilation mode in which the frequency, tidal volume, and inspiratory time of breathing are controlled by a ventilator because the patient has no spontaneous breathing or very weak spontaneous breathing.

Time Frame

within 28 days of the start of the trial

Title

Duration of ventilation

Description

It is defined as a date of ventilation within 28 days of the start of the trial.

Time Frame

within 28 days of the start of the trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhijie He

Phone

011-86-13710898290

hezhijie@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Fangyi Li

Phone

011-86-8615603056533

Lify8@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhijie He

Organizational Affiliation

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Official's Role

Study Director

12. IPD Sharing Statement

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

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