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

Not Applicable

• Conditions: Respiratory Insufficiency Requiring Mechanical Ventilation
• Interventions: Behavioral: Neuromuscular Electrical Stimulation

• Registration Number: NCT05217511
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-08
• Study First Submitted QC: 2022-01-27
• Status Verified: 2022-02
• Study Start: 2022-02-01
• Study First Posted: 2022-02-01
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMSE Group	Neuromuscular Electrical Stimulation	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.

Primary Outcome Measures

Name	Time	Method
diaphragmatic thickening fraction(DTF)	baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation	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

Name	Time	Method
Parasternal Intercostal Muscle Ultrasound	baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation	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.

Trial Locations

Locations (1)

Neuromuscular electrical stimulation; 🇨🇳 Qingdao, China