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

NCT ID: NCT00792441

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Ventilatory Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

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

Group Type: NO_INTERVENTION

intervention group

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

BreatheMax v.1; water pressure threshold breathing (WPTB)

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: collaborator

Saikaew Chuachan

OTHER

Sponsor Role: lead

Responsible Party

Saikaew Chuachan

Associated Medical Science

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Reechaipichitkul Wipa, MD

Role: STUDY_DIRECTOR

Department of medicine, Faculty of medicine, Khon Kaen university

Chulee CU Jones, Philosophy

Role: STUDY_DIRECTOR

Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university

Saikaew Chuachan, Bachelor

Role: STUDY_CHAIR

Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university

Locations

Respiratory Intensive Care Unit (RICU),Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

Other Identifiers

HE501034

Identifier Type: OTHER

Identifier Source: secondary_id

KKU4950900071

Identifier Type: -

Identifier Source: org_study_id