Clinical trial NCT00792441: Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence
Official title: Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilatory Defect
Keywords: Specific inspiratory muscle training(SIMT)
Loaded deep breathing
Weaning
Mechanical ventilation
Respiratory muscle
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
First posted: 2008-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Negative Inspiratory Pressure (PNIP)
timeFrame: every 7 day for 28 days
Secondary outcomes:
measure: Lung compliance
timeFrame: every 7 day for 28 days
measure: Vital capacity
timeFrame: every 7 day for 28 days
measure: Rate perceived breathlessness
timeFrame: every 7 day for 28 day
measure: Airway resistance
timeFrame: every 7 day for 28 days.
measure: Tidal volume
timeFrame: every 7 day for 28 days.
measure: Minute ventilation
timeFrame: every 7 day for 28 days.
measure: End tidal carbondioxide (PetCO2)
timeFrame: every 7 day for 28 days.
measure: SpO2
timeFrame: every 7 day for 28 days.
measure: Heart rate
timeFrame: every 7 day for 28 days.
measure: Respiratory rate
timeFrame: every 7 day for 28 days.
measure: Weaning success
timeFrame: every 7 day for 28 days.
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Respiratory Intensive Care Unit (RICU),Srinagarind Hospital
Study officials:
affiliation: Department of medicine, Faculty of medicine, Khon Kaen university
name: Reechaipichitkul Wipa, MD
role: STUDY_DIRECTOR
affiliation: Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
name: Chulee CU Jones, Philosophy
role: STUDY_DIRECTOR
affiliation: Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
name: Saikaew Chuachan, Bachelor
role: STUDY_CHAIR
References: