Respiration, ArtificialNCT02932189
Use of a New Isokinetic Device for Inspiratory Muscle Training
A study testing Inspiratory muscle training in people with Respiration, Artificial, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
Introduction: It is well established that physical fitness improves muscle performance either in sedentary people or in athletes. In this regard, specific exercises for respiratory muscles can result in better functional performance in hospitalized individuals, especially in critically ill patients in prolonged… Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to 15 Sep 2020
- 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 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals over the age of 18 on mechanical ventilation
- Able to initiate ventilator weaning.
Who cannot join
- Positive serology for HIV
- Other immunesupressive conditions
- Life expectancy less than 12 months
- Spinal cord injury above T8
- Mechanical ventilation started at another institution
- Body mass index >35 kg/m2.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Naval Marcilio Dias
Rio de Janeiro, Rio de Janeiro, 20725-090
About this study
Official title: Use of a New Isokinetic Device Oriented by Software for Inspiratory Muscle Training in Prolonged Weaning
Introduction:
It is well established that physical fitness improves muscle performance either in sedentary people or in athletes. In this regard, specific exercises for respiratory muscles can result in better functional performance in hospitalized individuals, especially in critically ill patients in prolonged weaning.
Read more
Objectives:
To compare the following variables between intervention and control patients: success in weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the use of the inspiratory muscle training (IMT).
Patients and methods:
Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary endpoint will be successful weaning. In addition, other variables such as free time off ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality in the ICU, inside the hospital and after discharge will be followed for one year after study entrance.
Expected results:
According to the working hypothesis, it is expected that the performance of patients undergoing IMT will be superior to the conventional treatment. Also, their time to mortality is expected to be longer.
Read the detailed description
The control group only performed inspiratory muscle training (IMT) with the use of the T-piece. From the first day of prolonged weaning, patients would remain in spontaneous breathing progressing their stay time each day, respecting the criteria already mentioned for interruption and return to mechanical ventilation in support pressure mode.
The intervention group, in addition to the protocol described above, would undergo inspiratory muscle training with the POWER breathe K-5 (UK) device. POWER breathe K-5 will be employed once a day, with an initial loading of 40% of maximal inspiratory strength in a schedule of 30 repetitions. This number of repetitions could be reached in one to 6 sessions depending on the respiratory muscle force of the patient. Most of the times more than one session were required. Typically, subjects performed two to six sessions of 5 to 15 breaths per day, with two minutes rest in ventilation pressure support mode. When the patient was unable to comply with the schedule, the training session was interrupted at a total of 3 minutes. The load was planned to be adjusted weekly with a 5 to 10% increase until 60% of the maximal inspiratory strength was reached with a total time of 10 minutes or 100 breaths. After training with POWER breathe K-5 (UK), the patient would return to mechanical ventilation in support pressure mode for 30-60 minutes, and then follow the conventional T-piece protocol. The IMT was conducted normally between 08h and 10h, Monday through Friday.
All study subjects would be under continuous surveillance through the multi-parameter DX 2010 monitor (Dixtal, São Paulo, SP, Brazil), which records the electrocardiogram, heart rate, peripheral oxygen saturation and systemic arterial pressure. At any sign of instability, the IMT was interrupted and the patient returned to the ventilatory support and/or supplemental oxygen therapy for recovery.
The trial was stopped if at least one of the following intolerance criteria was present: SaO2<90% or PaO2 <60 mm Hg with FIO2 >0.4; PaCO2 > 50 mm Hg or increased by > 8 mm Hg; arterial pH < 7.33 or decreased by 0.07 or more; breathing frequency > 35 breaths/min or increased by 50% for 5 min or longer; heart rate > 140 beats/min or a sustained increase or decrease of > 20%; mean blood pressure > 130 or < 70 mm Hg; or presence of agitation, diaphoresis, disorientation, or depressed mental status.
- Conditions
- Respiration, Artificial
- Being tested
- Inspiratory muscle training
- Keywords
- Mechanical Ventilator Weaning, Respiratory Muscle Training, Mortality Rate
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
For the inspiratory muscle training, an isokinetic device (K5 Power Breath, United Kingdom) will be attached to the artificial airway.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Procedure: Ventilator weaning in the conventional way with a tracheal collar. |
| Intervention | Experimental | Procedure: Ventilator weaning with a tracheal collar after inspiratory muscle training with an isokinetic device.
Device: K5 Power Breath Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful weaning
defined by 48 hours on spontaneous ventilation after ventilator withdrawal
Measured: one year
Secondary outcomes (3)
Change in maximal inspiratory strength in cm H2O as measured by the digital manovacuometer MVD300 for 60 seconds
Assessment of inspiratory strength by the maximal inspiratory pressure and the timed inspiratory effort index
Measured: one year
Change in the timed inspiratory effort index in cm H2O/sec as calculated by the ratio of the maximal inspiratory pressure and time demanded to reach it as measured by the digital manovacuometer MVD300 for 60 seconds
Assessment of inspiratory strength by the maximal inspiratory pressure and the timed inspiratory effort index
Measured: one year
Time off the ventilator in the ICU in days.
Assessment of the time the patients are kept in the ICU after the successful weaning,
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocemir Ronaldo Lugon, MD, Universidade Federal Fluminense
- Investigators
- Jocemir R Lugon, MD, PhD, Principal investigator, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932189
- Sponsor's protocol ID
- isokinetic device
- Status last verified
- Aug 2021
- First submitted
- 19 Sep 2016
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
da Silva Guimaraes B, de Souza LC, Cordeiro HF, Regis TL, Leite CA, Puga FP, Alvim SH, Lugon JR. Inspiratory Muscle Training With an Electronic Resistive Loading Device Improves Prolonged Weaning Outcomes in a Randomized Controlled Trial. Crit Care Med. 2021 Apr 1;49(4):589-597. doi: 10.1097/CCM.0000000000004787.
PubMed 33332819
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a New Isokinetic Device Oriented by Software for Inspiratory Muscle Training in Prolonged Weaning
- ClinicalTrials.gov ID
- NCT02932189
- Acronym / sponsor ID
- isokinetic device
- Conditions
- Respiration, Artificial
- Keywords
- Mechanical Ventilator Weaning, Respiratory Muscle Training, Mortality Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 13 Oct 2016 (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.
Introduction:
It is well established that physical fitness improves muscle performance either in sedentary people or in athletes. In this regard, specific exercises for respiratory muscles can result in better functional performance in hospitalized individuals, especially in critically ill patients in prolonged weaning.
Objectives:
To compare the following variables between intervention and control patients: success in weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the use of the inspiratory muscle training (IMT).
Patients and methods:
Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary endpoint will be successful weaning. In addition, other variables such as free time off ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality in the ICU, inside the hospital and after discharge will be followed for one year after study entrance.
Expected results:
According to the working hypothesis, it is expected that the performance of patients undergoing IMT will be superior to the conventional treatment. Also, their time to mortality is expected to be longer.
Detailed description
The control group only performed inspiratory muscle training (IMT) with the use of the T-piece. From the first day of prolonged weaning, patients would remain in spontaneous breathing progressing their stay time each day, respecting the criteria already mentioned for interruption and return to mechanical ventilation in support pressure mode.
The intervention group, in addition to the protocol described above, would undergo inspiratory muscle training with the POWER breathe K-5 (UK) device. POWER breathe K-5 will be employed once a day, with an initial loading of 40% of maximal inspiratory strength in a schedule of 30 repetitions. This number of repetitions could be reached in one to 6 sessions depending on the respiratory muscle force of the patient. Most of the times more than one session were required. Typically, subjects performed two to six sessions of 5 to 15 breaths per day, with two minutes rest in ventilation pressure support mode. When the patient was unable to comply with the schedule, the training session was interrupted at a total of 3 minutes. The load was planned to be adjusted weekly with a 5 to 10% increase until 60% of the maximal inspiratory strength was reached with a total time of 10 minutes or 100 breaths. After training with POWER breathe K-5 (UK), the patient would return to mechanical ventilation in support pressure mode for 30-60 minutes, and then follow the conventional T-piece protocol. The IMT was conducted normally between 08h and 10h, Monday through Friday.
All study subjects would be under continuous surveillance through the multi-parameter DX 2010 monitor (Dixtal, São Paulo, SP, Brazil), which records the electrocardiogram, heart rate, peripheral oxygen saturation and systemic arterial pressure. At any sign of instability, the IMT was interrupted and the patient returned to the ventilatory support and/or supplemental oxygen therapy for recovery.
The trial was stopped if at least one of the following intolerance criteria was present: SaO2<90% or PaO2 <60 mm Hg with FIO2 >0.4; PaCO2 > 50 mm Hg or increased by > 8 mm Hg; arterial pH < 7.33 or decreased by 0.07 or more; breathing frequency > 35 breaths/min or increased by 50% for 5 min or longer; heart rate > 140 beats/min or a sustained increase or decrease of > 20%; mean blood pressure > 130 or < 70 mm Hg; or presence of agitation, diaphoresis, disorientation, or depressed mental status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Procedure: Ventilator weaning in the conventional way with a tracheal collar. |
| Intervention | Experimental | Device: Inspiratory muscle trainingProcedure: Ventilator weaning with a tracheal collar after inspiratory muscle training with an isokinetic device. Device: K5 Power Breath |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals over the age of 18 on mechanical ventilation
- Able to initiate ventilator weaning.
Key exclusion criteria (6 listed)
- Positive serology for HIV
- Other immunesupressive conditions
- Life expectancy less than 12 months
- Spinal cord injury above T8
- Mechanical ventilation started at another institution
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 |
|---|---|---|
| Inspiratory muscle trainingFor the inspiratory muscle training, an isokinetic device (K5 Power Breath, United Kingdom) will be attached to the artificial airway. | Device | Intervention |
Primary outcome
Successful weaning
Time frame: one year
defined by 48 hours on spontaneous ventilation after ventilator withdrawal
3 secondary outcomes
Change in maximal inspiratory strength in cm H2O as measured by the digital manovacuometer MVD300 for 60 seconds
Time frame: one year
Change in the timed inspiratory effort index in cm H2O/sec as calculated by the ratio of the maximal inspiratory pressure and time demanded to reach it as measured by the digital manovacuometer MVD300 for 60 seconds
Time frame: one year
Time off the ventilator in the ICU in days.
Time frame: one year
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 5 Aug 2021.
- Derived from this study: PubMed 33332819da Silva Guimaraes B, de Souza LC, Cordeiro HF, Regis TL, Leite CA, Puga FP, Alvim SH, Lugon JR. Inspiratory Muscle Training With an Electronic Resistive Loading Device Improves Prolonged Weaning Outcomes in a Randomized Controlled Trial. Crit Care Med. 2021 Apr 1;49(4):589-597. doi: 10.1097/CCM.0000000000004787.
- Individual participant dataSharing planned: No
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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.
Jocemir R Lugon, MD, PhD principal investigator
Universidade Federal Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Respiration, Artificial, run by Universidade Federal Fluminense 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 2 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: finished, as of the sponsor's last update on 5 Aug 2021. 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?
Successful weaning (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932189, which also lists 1 linked publication.
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 5 Aug 2021.