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Completed

NCT Number: NCT03997214

The Impact of Inspiratory Muscle Strength Training

The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.

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Key information

Conditions

Ventilator Dependency

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shinghou Hospital

Kaohsiung City, Fengshan, 830, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >20y/o
  • Vital signs stable
  • MIP <20cmH2O
  • Ventilator FiO2<40%, PEEP <8
  • Ventilator mode:PSV or SIMV

Exclusion criteria

  • Patient or family refuse

Treatment and study plan

Inspiratory Muscle Strength Training

Device

The experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly.

Primary outcomes

  1. Maximal inspiratory pressure

    Time frame: 7 weeks

    a measure of the strength of inspiratory muscles, measurement by cmH2O.

  2. Tidal volume

    Time frame: 7 weeks

    the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration

  3. Minute ventilation volume

    Time frame: 7 weeks

    the quantity of air moved into and out of the lungs in a minute, measurement by l.min

  4. Rapid shallow breathing index

    Time frame: 7 weeks

    the ratio of respiratory frequency to tidal volume (f/VT)

  5. Oxygenation index.

    Time frame: 7 weeks

    Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization

Sponsors and collaborators

Lead sponsor

Fooyin University

Other

Registry information

Official study title

The Impact of Inspiratory Muscle Strength Training on Weaning Parameters Among Ventilator-dependent Patients

Acronym: IMT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 25, 2019
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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