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

Primary Purpose

Ventilatory Defect

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

intervention group

About this trial

This is an interventional treatment trial for Ventilatory Defect focused on measuring Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Respiratory Intensive Care Unit (RICU),Srinagarind Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

Peak Negative Inspiratory Pressure (PNIP)

Secondary Outcome Measures

Lung compliance

Vital capacity

Rate perceived breathlessness

Airway resistance

Tidal volume

Minute ventilation

End tidal carbondioxide (PetCO2)

SpO2

Heart rate

Respiratory rate

Weaning success

Full Information

NCT ID

NCT00792441

First Posted

November 17, 2008

Last Updated

April 1, 2015

Sponsor

Saikaew Chuachan

Collaborators

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT00792441

Brief Title

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

Acronym

SIMT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Saikaew Chuachan

Collaborators

Khon Kaen University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilatory Defect

Keywords

Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

intervention group

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Peak Negative Inspiratory Pressure (PNIP)

Time Frame

every 7 day for 28 days

Secondary Outcome Measure Information:

Title

Lung compliance

Time Frame

every 7 day for 28 days

Title

Vital capacity

Time Frame

every 7 day for 28 days

Title

Rate perceived breathlessness

Time Frame

every 7 day for 28 day

Title

Airway resistance

Time Frame

every 7 day for 28 days.

Title

Tidal volume

Time Frame

every 7 day for 28 days.

Title

Minute ventilation

Time Frame

every 7 day for 28 days.

Title

End tidal carbondioxide (PetCO2)

Time Frame

every 7 day for 28 days.

Title

SpO2

Time Frame

every 7 day for 28 days.

Title

Heart rate

Time Frame

every 7 day for 28 days.

Title

Respiratory rate

Time Frame

every 7 day for 28 days.

Title

Weaning success

Time Frame

every 7 day for 28 days.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reechaipichitkul Wipa, MD

Organizational Affiliation

Department of medicine, Faculty of medicine, Khon Kaen university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chulee CU Jones, Philosophy

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Saikaew Chuachan, Bachelor

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Respiratory Intensive Care Unit (RICU),Srinagarind Hospital

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

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

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