Effects of IMT on Weaning and Diaphragmatic Function in PMV Patients

NCT07200037 | Not Yet Recruiting

• 1 other identifier: 20250817001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prolonged mechanical ventilation (PMV) and weaning failure can lead to extended hospital stays, as well as increased morbidity and mortality during hospitalization. Therefore, PMV not only increases the economic burden on patients and their families, but also adds to the societal economic burden and consumes critical care medical resources. Inspiratory muscle training (IMT) is widely used by physical therapists in critically ill patients to improve respiratory function and enhance quality of life. IMT helps improve diaphragmatic function, and the improvement of diaphragmatic function in turn promotes better respiratory function, which is clinically significant for accelerating weaning. However, most studies on the effects of IMT on weaning success rates and the duration of mechanical ventilation have limitations such as small sample sizes, homogeneous patient populations, and short intervention periods. As a result, there is still no unified, high-quality evidence-based consensus. The purpose of this study is to further clarify the role of IMT in improving diaphragmatic function and increasing weaning success rates in patients with prolonged weaning, through clinical treatment and the collection and analysis of relevant data.

Conditions

Prolonged Mechanical Ventilation

Keywords

Inspiratory muscle training; Prolonged mechanical ventilation; weaning

Outcome Measures

Primary Outcomes (1)

• weaning success rate

  From enrollment to the end of treatment at 12 week

Secondary Outcomes (4)

• Diaphragmatic function

  from enrollment to the end of the treatment at 12 weeks

• maximal inspiratory pressure

  from enrollment to the end of the treatment at 8 weeks

• EQ-5D-5L

  From enrollment to the end of the intervention at 12 week

• FVC(forced vital capacity)

  from enrollment to the end of the ventilation at 12 week

Study Arms (2)

IMT group

EXPERIMENTAL

In this group, external load, initially 50%MIP , was daily adjusted to the highest tolerable load. The training is carried out 5 days a week for 8 weeks. The patient's MIP is measured every two weeks to adjust the training parameters in a timely manner to suit the patient's condition.

Behavioral: inspiratory muscle training

sham-IMT group

SHAM COMPARATOR

In this group, external load and maximal 10% MIP remained unadjusted. The training is carried out 5 days a week. The patient's MIP is measured every two weeks to adjust the training parameters in a timely manner to suit the patient's condition.

Behavioral: inspiratory muscle training

Interventions

inspiratory muscle training BEHAVIORAL

This intervention will include a long term program of 8 weeks IMT in PMV patients who these patients who have required at least 6h of mechanical ventilation for 21 consecutive days.

IMT group; sham-IMT group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• \) 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.-

Sponsors & Collaborators

• Capital Medical University: lead

Study Design

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

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-08