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

NCT05217511 | Unknown

• 1 other identifier: DZH20220104
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency Requiring Mechanical Ventilation

Keywords

Diaphragm ultrasound; Intercostal muscle ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parasternal Intercostal Muscle Ultrasound

  baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation

Other Outcomes (1)

• ventilator-free days at 28 days

  28 days

Study Arms (2)

NMSE Group

EXPERIMENTAL

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

CPT group

NO INTERVENTION

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.

Interventions

Neuromuscular Electrical Stimulation BEHAVIORAL

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.

NMSE Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Neuromuscular electrical stimulation

Qingdao, 266003, China

RECRUITING

Study Officials

• Jinyan Xing, Dr.

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Central Study Contacts

Zehua Dong, Dr.

CONTACT

86-0532-82919386; liuyingwallace@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

CN (1)