Critical CareNCT00851617
Does Threshold IMT Influence Weaning?
A study testing Threshold® IMT in people with Critical Care and Mechanical Ventilation, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Patients under threshold IMT show better conditions to weaning from mechanical ventilation than the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Mechanical Ventilation
- What is being tested?
- Threshold® IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2004to Jul 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients included in this study were under MV for more than 48 hours of CMV and ventilated with pressure support ventilation (PSV) between 12 and 15 cmH2O, with positive end-expiratory pressure (PEEP) between 5 and 7 cmH2O, hemodynamically stable without vasoactive drugs (dopamine, dobutamine or norepinephrine) or sedative agents.
Who cannot join
- This study excluded hypotensive patients (systolic blood pressure < 100 mmHg or mean blood pressure < 70 mmHg), severe intracranial disease and sensory reduction, barotrauma, tracheotomy, neuromuscular disease and the use of vasoactive drugs or sedatives.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?
Patients under threshold IMT show better conditions to weaning from mechanical ventilation than the control group.
Read the detailed description
- After at least 48 hours on CMV, the patients in PSV were randomized into two groups: control group and IMT group.
- Before each protocol session, the cardiorespiratory variables such as f, HR, MAP and SpO2, as well as the support ventilatory variables such as PSV, PEEP, FiO2 and trigger sensitivity, were recorded.
- After collecting the first records, the patients were placed in a 45º Fowler position, and variables MIP and MEP were collected with a unidirectional valve, as well as f, VE, Vt and f/Vt.
- The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day. Supplementary oxygen was added if necessary during the protocol. The training was cancelled in the presence of tachyarrhythmia, reduction of SpO2 under 85% and in the presence of fatigue signs or respiratory dysfunction. In this case, the patients returned to MV. All cardiorespiratory variables (f, HR, MAP and SpO2) were recorded again one minute after the end of the protocol. The same data were recorded in the control group before and after the protocol, but the patients were not trained with the threshold IMT device.
- All patients were followed up until weaning. During this period, laboratory tests were recorded, such as: potassium, sodium and magnesium as well as arterial gasometry, calculating the partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio.
- Conditions
- Critical Care, Mechanical Ventilation
- Being tested
- Threshold® IMT
- Keywords
- Mechanical ventilator weaning, Respiratory Muscle Training, Ventilator dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold® IMTDevice
The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day
| Study group | Role | What they receive |
|---|---|---|
| IMT Group | Experimental | The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day Receives: Device: Threshold® IMT |
| Control Group | No intervention | Patients were evaluated until weaning without interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning Acceleration
Measured: Time weaning measured in hours
Secondary outcomes (1)
Strenght and ventilatory variables
Measured: Time weaning measured in hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startAug 2004
- Primary completionMar 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Silvia Vieira, PhD, Principal investigator, Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851617
- Sponsor's protocol ID
- 04-391
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Threshold IMT Useful To Accelerate Weaning From Mechanical Ventilation?
- ClinicalTrials.gov ID
- NCT00851617
- Acronym / sponsor ID
- 04-391
- Conditions
- Critical Care, Mechanical Ventilation
- Keywords
- Mechanical ventilator weaning, Respiratory Muscle Training, Ventilator dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 Feb 2009 (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.
Patients under threshold IMT show better conditions to weaning from mechanical ventilation than the control group.
Detailed description
- After at least 48 hours on CMV, the patients in PSV were randomized into two groups: control group and IMT group.
- Before each protocol session, the cardiorespiratory variables such as f, HR, MAP and SpO2, as well as the support ventilatory variables such as PSV, PEEP, FiO2 and trigger sensitivity, were recorded.
- After collecting the first records, the patients were placed in a 45º Fowler position, and variables MIP and MEP were collected with a unidirectional valve, as well as f, VE, Vt and f/Vt.
- The IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day. Supplementary oxygen was added if necessary during the protocol. The training was cancelled in the presence of tachyarrhythmia, reduction of SpO2 under 85% and in the presence of fatigue signs or respiratory dysfunction. In this case, the patients returned to MV. All cardiorespiratory variables (f, HR, MAP and SpO2) were recorded again one minute after the end of the protocol. The same data were recorded in the control group before and after the protocol, but the patients were not trained with the threshold IMT device.
- All patients were followed up until weaning. During this period, laboratory tests were recorded, such as: potassium, sodium and magnesium as well as arterial gasometry, calculating the partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT Group | Experimental | Device: Threshold® IMTThe IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day |
| Control Group | No intervention | –Patients were evaluated until weaning without interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients included in this study were under MV for more than 48 hours of CMV and ventilated with pressure support ventilation (PSV) between 12 and 15 cmH2O, with positive end-expiratory pressure (PEEP) between 5 and 7 cmH2O, hemodynamically stable without vasoactive drugs (dopamine, dobutamine or norepinephrine) or sedative agents.
Key exclusion criteria (1 listed)
- This study excluded hypotensive patients (systolic blood pressure < 100 mmHg or mean blood pressure < 70 mmHg), severe intracranial disease and sensory reduction, barotrauma, tracheotomy, neuromuscular disease and the use of vasoactive drugs or sedatives.
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 |
|---|---|---|
| Threshold® IMTThe IMT group was trained using the threshold IMT device with a 40% MIP load. Each training session consisted of 5 sets with 10 breaths, twice a day | Device | IMT Group |
Primary outcome
Weaning Acceleration
Time frame: Time weaning measured in hours
1 secondary outcome
Strenght and ventilatory variables
Time frame: Time weaning measured in hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
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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.
Silvia Vieira, PhD principal investigator
Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold® IMT in people with Critical Care and Mechanical Ventilation, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2009. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weaning Acceleration (time frame: Time weaning measured in hours). 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 6 Mar 2009.