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

NCT ID: NCT05217511

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

JinyanXing

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinyan Xing, Dr.

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

Neuromuscular electrical stimulation

Qingdao, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zehua Dong, Dr.

Role: CONTACT

liuyingwallace@163.com

86-0532-82919386

Facility Contacts

Zehua Dong, Dr.

Role: primary

liuyingwallace@163.com

18661803112

Other Identifiers

DZH20220104

Identifier Type: -

Identifier Source: org_study_id