Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence

Not Applicable

• Conditions: Ventilatory Defect
• Interventions: Device: intervention group

• Registration Number: NCT00792441
• Lead Sponsor: Saikaew Chuachan

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Primary Completion: 2009-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention group	intervention group	Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University

Primary Outcome Measures

Name	Time	Method
Peak Negative Inspiratory Pressure (PNIP)	every 7 day for 28 days

Secondary Outcome Measures

Name	Time	Method
Tidal volume	every 7 day for 28 days.
End tidal carbondioxide (PetCO2)	every 7 day for 28 days.
Heart rate	every 7 day for 28 days.
Airway resistance	every 7 day for 28 days.
Rate perceived breathlessness	every 7 day for 28 day
SpO2	every 7 day for 28 days.
Weaning success	every 7 day for 28 days.
Vital capacity	every 7 day for 28 days
Minute ventilation	every 7 day for 28 days.
Lung compliance	every 7 day for 28 days
Respiratory rate	every 7 day for 28 days.

Trial Locations

Locations (1)

Respiratory Intensive Care Unit (RICU),Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand