Ventilatory DefectSIMTNCT00792441
Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence
A study testing intervention group in people with Ventilatory Defect, run by Saikaew Chuachan at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Ventilatory Defect
- What is being tested?
- intervention group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Respiratory Intensive Care Unit (RICU),Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
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.
Read the 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
- Being tested
- intervention group
- Keywords
- Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupDevice
Also called BreatheMax v.1, water pressure threshold breathing (WPTB)
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | No intervention | Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University Receives: Device: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Negative Inspiratory Pressure (PNIP)
Measured: every 7 day for 28 days
Secondary outcomes (11)
Lung compliance
Measured: every 7 day for 28 days
Vital capacity
Measured: every 7 day for 28 days
Rate perceived breathlessness
Measured: every 7 day for 28 day
Airway resistance
Measured: every 7 day for 28 days.
Tidal volume
Measured: every 7 day for 28 days.
Minute ventilation
Measured: every 7 day for 28 days.
End tidal carbondioxide (PetCO2)
Measured: every 7 day for 28 days.
SpO2
Measured: every 7 day for 28 days.
Heart rate
Measured: every 7 day for 28 days.
Respiratory rate
Measured: every 7 day for 28 days.
Weaning success
Measured: every 7 day for 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2009
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saikaew Chuachan
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University
- Responsible party
- Sponsor-investigator, Saikaew Chuachan, Khon Kaen University
- Investigators
- Reechaipichitkul Wipa, MD, Study director, Department of medicine, Faculty of medicine, Khon Kaen universityChulee CU Jones, Philosophy, Study director, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen universitySaikaew Chuachan, Bachelor, Study chair, Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792441
- Sponsor's protocol ID
- KKU4950900071
- Other IDs
- HE501034
- Acronym
- SIMT
- Status last verified
- Apr 2015
- First submitted
- 17 Nov 2008
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
- ClinicalTrials.gov ID
- NCT00792441
- Acronym / sponsor ID
- SIMT / KKU4950900071
- Conditions
- Ventilatory Defect
- Keywords
- Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Saikaew ChuachanUniversity, hospital or other
- Collaborators
- Khon Kaen University
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention group | No intervention | Device: intervention groupPatients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Persistent homodynamic instability.
- Severe breathlessness at rest when spontaneous breathing.
- Coronary heart disease with angina.
- Life threatening arrhythmia (VF, VT).
- Sedation Ramsay scale > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention groupAlso: BreatheMax v.1, water pressure threshold breathing (WPTB)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. | Device | intervention group |
Primary outcome
Peak Negative Inspiratory Pressure (PNIP)
Time frame: every 7 day for 28 days
11 secondary outcomes
Lung compliance
Time frame: every 7 day for 28 days
Vital capacity
Time frame: every 7 day for 28 days
Rate perceived breathlessness
Time frame: every 7 day for 28 day
Airway resistance
Time frame: every 7 day for 28 days.
Tidal volume
Time frame: every 7 day for 28 days.
Minute ventilation
Time frame: every 7 day for 28 days.
End tidal carbondioxide (PetCO2)
Time frame: every 7 day for 28 days.
SpO2
Time frame: every 7 day for 28 days.
Heart rate
Time frame: every 7 day for 28 days.
Respiratory rate
Time frame: every 7 day for 28 days.
Weaning success
Time frame: every 7 day for 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reechaipichitkul Wipa, MD study director
Department of medicine, Faculty of medicine, Khon Kaen university
Chulee CU Jones, Philosophy study director
Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Saikaew Chuachan, Bachelor study chair
Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Ventilatory Defect, run by Saikaew Chuachan at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Negative Inspiratory Pressure (PNIP) (time frame: every 7 day for 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.