This trial is active, not recruiting.

Condition ventilatory defect
Treatment intervention group
Sponsor Saikaew Chuachan
Collaborator Khon Kaen University
Start date January 2007
End date December 2009
Trial size 20 participants
Trial identifier NCT00792441, HE501034, KKU4950900071


Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning failure,the investigators hypothesize that

1. Specific inspiratory muscle training (SIMT) using threshold loaded breathing device (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle strength

2. SIMT will improve lung function in patients with ventilatory dependence.

3. SIMT will improve weaning success in patients with ventilatory dependence.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
(No Intervention)
Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University
intervention group BreatheMax v.1
inspiratory muscle training at 50% of peak negative inspiratory muscle training (PNIP)will be performed with 6 breathe/set, 10 set/day, once a day for 28 days.

Primary Outcomes

Peak Negative Inspiratory Pressure (PNIP)
time frame: every 7 day for 28 days

Secondary Outcomes

Lung compliance
time frame: every 7 day for 28 days
Vital capacity
time frame: every 7 day for 28 days
Rate perceived breathlessness
time frame: every 7 day for 28 day
Airway resistance
time frame: every 7 day for 28 days.
Tidal volume
time frame: every 7 day for 28 days.
Minute ventilation
time frame: every 7 day for 28 days.
End tidal carbondioxide (PetCO2)
time frame: every 7 day for 28 days.
time frame: every 7 day for 28 days.
Heart rate
time frame: every 7 day for 28 days.
Respiratory rate
time frame: every 7 day for 28 days.
Weaning success
time frame: every 7 day for 28 days.

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: - Patient who have been mechanically ventilated > 72 hours and start to weaning from medical order or ventilator dependent patients who have failed to wean prior to study. - Normal arterial blood gas (PaCO2 < 50mmHg, PaO2 > 60 mmHg on FiO2 <0.5 or SaO2 > 90%, PH 7.35-7.45). - Cardiovascular stability (HR ≤ 140 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg, with no or minimal vasopressors) - Good consciousness, cooperation and can sit in an upright position > 30 minutes Exclusion Criteria: - Persistent homodynamic instability. - Severe breathlessness at rest when spontaneous breathing. - Coronary heart disease with angina. - Life threatening arrhythmia (VF, VT). - Sedation Ramsay scale > 2 - Severity of disease APACHE II score > 29

Additional Information

Official title Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
Description Prolonged mechanical ventilation cause detrimental effects on lung function and high risk of lung complications and standard weaning protocols are not successful in a number of patients. The strength of the inspiratory muscles is important factors in the success of weaning. Although, the inspiratory muscles are trained by manipulating the ventilator sensitivity and made of ventilation in the traditional protocol, the muscle function might not improved sufficiently to sustain independent and spontaneous breathing. Consequently, specific inspiratory muscle training is indicated and has been studied in patient with weaning failure. However, there is little evidence available and no firm conclusion can be drown. Therefore, the purpose of this study is to determine whether specific IMT training using the local made loaded threshold IMT device can improve lung function and accelerate the weaning process.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Khon Kaen University.