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High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation

Primary Purpose

Prolonged Mechanical Ventilation, Protein Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
UC + high protein diet (HP)
UC + HP + core muscle rehabilitation
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prolonged Mechanical Ventilation

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age ≥ 20 year old using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube) stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability) maximal inspiratory pressure (MIP) < 30mmHg under enteral nutrition (EN) via NG tube. Exclusion Criteria: Acute infection and sepsis (fever up to 38.5 degree) Severe neuromuscular disease, or uncontrolled epilepsy Bony fracture or DVT history Wound over the abdomen Congestive heart failure with EF < 40% or using pacemaker BMI>35 kg/M2, or severe edema Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded. Under parenteral nutrition (PN) Use pacemaker

Sites / Locations

  • Department of Thoracic Medicine, Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Usual care

UC + high protein diet (HP)

UC + HP + core muscle rehabilitation

UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

Arm Description

Usual care as RCC protocol in Chang Gung Memorial hospital

The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.

NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA].

Outcomes

Primary Outcome Measures

Weaning rate
weaning success defined as weaning from ventilator for 5 consecutive days

Secondary Outcome Measures

In hospital mortality
Mortality event in this admission
Length of mechanical ventilator usage
total ventilator use days in this admission
Length of ICU stay and total length of hospitalization
total ICU stay and hospitalization days

Full Information

First Posted
April 26, 2023
Last Updated
October 23, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05932134
Brief Title
High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation
Official Title
The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients With Prolonged Mechanical Ventilation (PMV〕
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
March 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are: High protein formula intake benefit in successful weaning from ventilator Core muscle rehabilitation benefit in successful weaning from ventilator neuromuscular electric stimulation benefit in successful weaning from ventilator Participants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (NMES). Researchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
Detailed Description
The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator: High protein formula intake benefit in successful weaning from ventilator Core muscle rehabilitation benefit in successful weaning from ventilator neuromuscular electric stimulation benefit in successful weaning from ventilator Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES). Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Mechanical Ventilation, Protein Deficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES). Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care as RCC protocol in Chang Gung Memorial hospital
Arm Title
UC + high protein diet (HP)
Arm Type
Experimental
Arm Description
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
Arm Title
UC + HP + core muscle rehabilitation
Arm Type
Experimental
Arm Description
Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.
Arm Title
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Arm Type
Experimental
Arm Description
NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA].
Intervention Type
Dietary Supplement
Intervention Name(s)
UC + high protein diet (HP)
Intervention Description
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
Intervention Type
Behavioral
Intervention Name(s)
UC + HP + core muscle rehabilitation
Intervention Description
Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks
Intervention Type
Device
Intervention Name(s)
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Intervention Description
NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA].
Primary Outcome Measure Information:
Title
Weaning rate
Description
weaning success defined as weaning from ventilator for 5 consecutive days
Time Frame
3 months
Secondary Outcome Measure Information:
Title
In hospital mortality
Description
Mortality event in this admission
Time Frame
6 months
Title
Length of mechanical ventilator usage
Description
total ventilator use days in this admission
Time Frame
3 months
Title
Length of ICU stay and total length of hospitalization
Description
total ICU stay and hospitalization days
Time Frame
6 momnths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 20 year old using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube) stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability) maximal inspiratory pressure (MIP) < 30mmHg under enteral nutrition (EN) via NG tube. Exclusion Criteria: Acute infection and sepsis (fever up to 38.5 degree) Severe neuromuscular disease, or uncontrolled epilepsy Bony fracture or DVT history Wound over the abdomen Congestive heart failure with EF < 40% or using pacemaker BMI>35 kg/M2, or severe edema Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded. Under parenteral nutrition (PN) Use pacemaker
Facility Information:
Facility Name
Department of Thoracic Medicine, Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horng-Chyuan Lin
Phone
+8863281200
Ext
8470
Email
Lin53424@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36297079
Citation
Huang SW, Lin HC, Chou YF, Lin TY, Lo CY, Huang HY, Fang YF, Hsieh MH, Lin SM, Lo YL, Hsieh MJ, Kao KC, Lin CY, Huang CC. The Impact of Higher Protein Intake in Patients with Prolonged Mechanical Ventilation. Nutrients. 2022 Oct 20;14(20):4395. doi: 10.3390/nu14204395.
Results Reference
result

Learn more about this trial

High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation

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