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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation
• Intervention / Treatment: Behavioral: Neuromuscular Electrical Stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 47
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zehua Dong, Dr.; Phone Number: 86-0532-82919386; Email: liuyingwallace@163.com

Study Locations

• China
  • Qingdao, China, 266003
    • Recruiting
    • Neuromuscular electrical stimulation
    • Contact: Zehua Dong, Dr.; Phone Number: 18661803112; Email: liuyingwallace@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMSE Group; 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.	Behavioral: Neuromuscular Electrical Stimulation; 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.
No Intervention: CPT group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation

Other Outcome Measures

Outcome Measure	Time Frame
ventilator-free days at 28 days	28 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Study Director: Jinyan Xing, Dr., The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: January 8, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Diaphragm ultrasound; Intercostal muscle ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: DZH20220104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No