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

Sponsor

Saikaew Chuachan (Other)

Overall Status

Unknown status

CT.gov ID

NCT00792441

Collaborator

Khon Kaen University (Other)

Enrollment

Location

Arm

107

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Condition or Disease	Intervention/Treatment	Phase
Ventilatory Defect	Device: intervention group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: intervention group Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University	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. Other Names: BreatheMax v.1 water pressure threshold breathing (WPTB)

Arm

Intervention/Treatment

No Intervention: intervention group

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

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.

Other Names:

BreatheMax v.1

water pressure threshold breathing (WPTB)

Outcome Measures

Primary Outcome Measures

Peak Negative Inspiratory Pressure (PNIP) [every 7 day for 28 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Respiratory Intensive Care Unit (RICU),Srinagarind Hospital	Khon Kaen		Thailand	40002

Sponsors and Collaborators

Saikaew Chuachan
Khon Kaen University

Investigators

Study Director: Reechaipichitkul Wipa, MD, Department of medicine, Faculty of medicine, Khon Kaen university
Study Director: Chulee CU Jones, Philosophy, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Study Chair: Saikaew Chuachan, Bachelor, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university