Inspiratory Muscle Training in Prolonged Mechanical Ventilation
inspiratory muscle training
Treatment Study
Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.This study focuses on a method called inspiratory muscle training (IMT), which is used to help patients who are on ventilators regain their ability to breathe on their own. These patients often struggle to be "weaned off" the ventilators, meaning they have difficulty transitioning to breathing independently after using a machine for an extended period. IMT involves exercises that strengthen the muscles used for breathing, particularly the diaphragm. This strength training can potentially shorten the time patients need mechanical ventilation and improve the overall success rate of weaning, thereby enhancing their quality of life. Participants in this study engage in specific breathing exercises designed to strengthen their inspiratory muscles. The effectiveness of this training is evaluated by comparing the time it takes for patients to be weaned from the ventilator with those not receiving the training. The study also uses ultrasound to examine various aspects of diaphragm function, such as its movement and thickness. Though the study does not report specific risks, the exercises are considered safe and feasible for patients. The potential benefit is a quicker recovery and improved ability to breathe independently, which is crucial for patients with prolonged mechanical ventilation dependency.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Patients who received therapy in the HDU of the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital Affiliated to Capital Medical University and met the PMV criteria clearly recommended by the NAMDRC consensus in 2005, which is "mechanical ventilation for at least 6 hours a day for 21 consecutive days". * The patients' conditions were relatively stable, they were conscious, had no intellectual disability, no mental illness, no cognitive impairment, and gave informed consent. * They had spontaneous breathing and could tolerate short periods of being off the ventilator to complete the training. * The ventilator parameters met the following requirements: PEEP ≤ 10 cmH2O, FiO2 \< 0.60, RR \< 25. Exclusion Criteria: 1\) brain injuries, pulmonary contusions and lacerations, rib fractures, unhealed wounds in the chest and abdomen, etc. The condition is severe, and inspiratory muscle training and diaphragm ultrasound assessment cannot be performed. 2) No spontaneous breathing, completely dependent on mechanical ventilation; 3) Pre-existing pulmonary infection or severe heart, lung or kidney diseases before clinical trials, with unstable hemodynamics; 4) Poor cognitive function, poor compliance, and non-cooperation with treatment.-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives