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Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation

Primary Purpose

Respiratory Insufficiency Requiring Mechanical Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency Requiring Mechanical Ventilation focused on measuring Diaphragm ultrasound, Intercostal muscle ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prolonged MV(>72 h);
  • Written informed consent was obtained from the patients or their relatives

Exclusion Criteria:

  • Previous neuromuscular disease;
  • Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
  • Thoracic or diaphragmatic malformation;
  • Local skin damage and infection;
  • Indwelling a temporary or permanent pacemaker;
  • Severe obesity(BMI>35 kg/m2)
  • Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement;
  • Patients with an expected survival time of less than 7 days or with palliative care

Sites / Locations

  • Neuromuscular electrical stimulationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NMSE Group

CPT group

Arm Description

Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.

The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.

Outcomes

Primary Outcome Measures

diaphragmatic thickening fraction(DTF)
DTF shows varied thickness of the diaphragm at end-expiration and end-inspiration. Te maximum and minimum values of each breathing cycle were taken as the end-inspiratory diaphragm thickness (DTei) and the end-expiratory diaphragm thickness (DTee), respectively. DTF was calculated by DTF=(DTei DTee)/DTee 100%. Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value

Secondary Outcome Measures

Parasternal Intercostal Muscle Ultrasound
A 10- to 15-MHz linear array transducer was positioned perpendicular to the anterior thorax surface in the longitudinal scan, at the level of the second right intercostal space, approximately 6 to 8 cm lateral to the sternal edge with a window visualizing the second and third ribs. . Using M-mode, the ultrasound beam was perpendicularly directed at the midsection of the muscle, where it is the thinnest at end-expiration. The thickness of the parasternal intercostal muscle was measured on frozen images at end expiration and at peak inspiration.

Full Information

First Posted
January 8, 2022
Last Updated
February 14, 2022
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05217511
Brief Title
Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
Official Title
Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency Requiring Mechanical Ventilation
Keywords
Diaphragm ultrasound, Intercostal muscle ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMSE Group
Arm Type
Experimental
Arm Description
Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
Arm Title
CPT group
Arm Type
No Intervention
Arm Description
The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
NMES was performed using a portable machine.The negative electrodes were placed in the motor points of the following muscles: chest muscles (pectoralis major muscle fibres) and rectus abdominis muscles bilaterally. A second (positive) electrode was positioned distally to the first, at a site close to the muscle that was being electrically stimulated, totalling 1 channel with 2 electrodes for each muscle . Each NMES session lasted 30 min. The following parameters were used: 50 Hz frequency, pulse duration 300 ms, rise time 1 s, stimulus time (ON) 3 s, decay time 1 s, and relaxation time (OFF) 10 s. Intensity was increased until muscle contraction was visible or could be identified through palpation. In conscious patients, intensity was adjusted according to their tolerance.
Primary Outcome Measure Information:
Title
diaphragmatic thickening fraction(DTF)
Description
DTF shows varied thickness of the diaphragm at end-expiration and end-inspiration. Te maximum and minimum values of each breathing cycle were taken as the end-inspiratory diaphragm thickness (DTei) and the end-expiratory diaphragm thickness (DTee), respectively. DTF was calculated by DTF=(DTei DTee)/DTee 100%. Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value
Time Frame
baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Secondary Outcome Measure Information:
Title
Parasternal Intercostal Muscle Ultrasound
Description
A 10- to 15-MHz linear array transducer was positioned perpendicular to the anterior thorax surface in the longitudinal scan, at the level of the second right intercostal space, approximately 6 to 8 cm lateral to the sternal edge with a window visualizing the second and third ribs. . Using M-mode, the ultrasound beam was perpendicularly directed at the midsection of the muscle, where it is the thinnest at end-expiration. The thickness of the parasternal intercostal muscle was measured on frozen images at end expiration and at peak inspiration.
Time Frame
baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Other Pre-specified Outcome Measures:
Title
ventilator-free days at 28 days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prolonged MV(>72 h); Written informed consent was obtained from the patients or their relatives Exclusion Criteria: Previous neuromuscular disease; Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites Thoracic or diaphragmatic malformation; Local skin damage and infection; Indwelling a temporary or permanent pacemaker; Severe obesity(BMI>35 kg/m2) Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement; Patients with an expected survival time of less than 7 days or with palliative care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehua Dong, Dr.
Phone
86-0532-82919386
Email
liuyingwallace@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyan Xing, Dr.
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
Neuromuscular electrical stimulation
City
Qingdao
ZIP/Postal Code
266003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehua Dong, Dr.
Phone
18661803112
Email
liuyingwallace@163.com

12. IPD Sharing Statement

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Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation

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