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

Ventilatory Defect Clinical Trial

— SIMT  

Official title:

Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00792441
• Other study ID #: KKU4950900071
• Secondary ID: HE501034
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2008
• Last updated: April 1, 2015
• Start date: January 2007
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Aspiration
• Ventilatory Defect

Intervention

Device:
• intervention group
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.

Locations

Country	Name	City	State
Thailand	Respiratory Intensive Care Unit (RICU),Srinagarind Hospital	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Saikaew Chuachan	Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Negative Inspiratory Pressure (PNIP)		every 7 day for 28 days	Yes
Secondary	Lung compliance		every 7 day for 28 days	Yes
Secondary	Vital capacity		every 7 day for 28 days	Yes
Secondary	Rate perceived breathlessness		every 7 day for 28 day	Yes
Secondary	Airway resistance		every 7 day for 28 days.	Yes
Secondary	Tidal volume		every 7 day for 28 days.	Yes
Secondary	Minute ventilation		every 7 day for 28 days.	Yes
Secondary	End tidal carbondioxide (PetCO2)		every 7 day for 28 days.	Yes
Secondary	SpO2		every 7 day for 28 days.	Yes
Secondary	Heart rate		every 7 day for 28 days.	Yes
Secondary	Respiratory rate		every 7 day for 28 days.	Yes
Secondary	Weaning success		every 7 day for 28 days.	Yes