Effects of IMT on Weaning and Diaphragmatic Function in PMV Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: IMT groupExperimental treatment 1 intervention
Group B: sham-IMT groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

weaning success rate

Time frame
From enrollment to the end of treatment at 12 week

Secondary outcomes

1

Diaphragmatic function

DE in centimeter、thickness in millimeter、DTF in proportion

Time frame
from enrollment to the end of the treatment at 12 weeks
2

maximal inspiratory pressure

Time frame
from enrollment to the end of the treatment at 8 weeks
3

EQ-5D-5L

Time frame
From enrollment to the end of the intervention at 12 week
4

FVC(forced vital capacity)

FVC in liters

Time frame
from enrollment to the end of the ventilation at 12 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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