Weaning FailureNCT04347317
Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?
A study testing Low Intensity IMT and High Intensity IMT in people with Weaning Failure, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial summary
Introduction: It has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longer duration of mechanical ventilation and increased risk of complications and death. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Low Intensity IMT and High Intensity IMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical patients aged ≥ 18 years hospitalized in the ICU.
- Patients ventilated by tracheostomy and who have failed ≥ 1 spontaneous breathing test.
- Being ventilated in assisted-controlled, assisted or pressure support modes.
- PEEP ≤ 10 cmH2O
- Richmond Agitation-Sedation Scale between -1 and 0.
- Confusion Assessment Method for the Intensive Care Unit negative.
Show all 10Show fewer
- Cardiorespiratory and hemodynamic stability in the absence of vasopressor support or with minimal requirement (dobutamine or dopamine ≤ 5 μg / kg / min, phenylephrine ≤ 1 μg / kg / min).
- FiO2 ≤ 0,6
- PaO2/FiO2 ratio > 200
- Blood lactate levels < 4 mmol/L
Who cannot join
- Progressive neuromuscular disease
- Thoraco-abdominal surgery in a period <30 days from the beginning of the study.
- Diseases that cause hemodynamic instability (cardiac arrhythmia, decompensated heart failure, unstable ischemic heart disease).
- Hemoptysis
- Unstable chest wall.
- Not drained pneumothorax
Show all 16Show fewer
- Phrenic nerve injury
- Spinal cord injury above T8
- Clinical signs of respiratory distress (paradoxal breathing, use of accessory respiratory muscles)
- Body mass index > 40 kg / m2
- Use domiciliary ventilator support prior to hospitalization.
- Skeletal disorder of the rib cage that impairs its biomechanics (severe kyphoscoliosis, congenital deformities).
- Body temperature > 38ºC
- Pregnancy
- Receive therapy with nitric oxide or nebulized prostacyclin.
- Medical order.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, 08035
Bernat Planas Pascual, PT, MSc, +34934892465, bplanas@vhebron.net
Esther Batlle Borraz, PT, +34697964618, esther.batlle.borraz@gmail.com
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Bernat Planas Pascual, MSc
About this study
Official title: Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning Admitted in the Intensive Care Unit?
Introduction: It has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longer duration of mechanical ventilation and increased risk of complications and death. Consequently, the duration of stay in ICU is longer and the costs in ICU increase.
Objectives: To determine the effects of a high intensity inspiratory muscle training (IMT) on inspiratory muscle strength, weaning outcomes, complications and length of stay in the ICU in medical patients with difficulty on weaning and admitted in the ICU.
Read more
Methodology: In a single blind randomized clinical trial, 40 tracheotomy ventilated medical patients in which spontaneous breathing trial has failed ≥ 1 time, will be selected and randomized into two equitable groups. In the intervention group, IMT will be performed at 60% of the maximum inspiratory pressure (which will increase by 10% every week) while in the control group it will be performed at 30%. In both groups, 5 sets of 6 breaths will be performed, once a day, 5 days a week, for a maximum of 28 days or until the patient is successfully weaned. The main outcome will be the maximum inspiratory pressure, while the maximum expiratory pressure, weaning duration process, weaning success, duration of mechanical ventilation, length of stay in the ICU, complications and the rapid shallow breathing index will be analyzed as secondary outcomes.
t-student test for independent samples will be used to analyze quantitative outcomes. For qualitative outcomes will be used X2 test. A value of p<0.05 will be assumed as an indicator of statistically significant results.
Future contributions: Our collect results can be useful for the updating of the clinical practice guidelines and promote its implementation in the clinical practice.
- Conditions
- Weaning Failure
- Being tested
- Low Intensity IMT, High Intensity IMT
- Keywords
- mechanical ventilator weaning, mechanical ventilation, difficult weaning, intensive care unit, inspiratory muscle training, ventilator-induced diaphragmatic dysfunction, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity IMTProcedure or surgery
The control group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 30% of the MIP and will be increased by 10% of the initial MIP weekly.
The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity.
High Intensity IMTProcedure or surgery
The experimental group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 60% of the MIP and will be increased by 10% of the initial MIP weekly.
The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity IMT | Active comparator | Not described Receives: Procedure: Low Intensity IMT |
| High Intensity IMT | Experimental | Not described Receives: Procedure: High Intensity IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Measured with MIP (Maximal Inspiratory Pressure)
Assessments:
Baseline, after the intervention period
Measured: Through study completion, an average of 28 days
Secondary outcomes (7)
Expiratory muscle strength
Measured with MEP (Maximal Expiratory Pressure)
Baseline, after the intervention period
Measured: Through study completion, an average of 28 days
Rapid Shallow Breathing Index
Measured with the mechanical ventilator
Measured: Through study completion, an average of 28 days
Duration of the weaning period
Defined as the hours since the first attempt of spontaneous breathing (or the initiation of pressure support ≤ 7 cmH2O) to successful weaning
Measured: Through study completion, an average of 28 days
Weaning success
Recorded as successfully if the patient can breathe spontaneously through tracheostomy without restart mechanical ventilation for at least 48 hours.
Measured: Through study completion, an average of 28 days
Duration of mechanical ventilation
Recorded as the days since patient was connected to mechanical ventilator to successful weaning.
Measured: Through study completion, an average of 28 days
Length of stay in the ICU
Measured in days.
Measured: Through study completion, an average of 28 days
Complications
Defined as the patient needs to be intubated again when the patient was weaned or the death of the participant
Measured: Through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Jun 2021 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernat Planas Pascual, PT,MSc, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347317
- Sponsor's protocol ID
- PR(ATR)03/2020
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dixit A, Prakash S. Effects of threshold inspiratory muscle training versus conventional physiotherapy on the weaning period of mechanically ventilated patients: a comparative study. Int J Physiother Res. 2014;2(2):424-8
Moodie L, Reeve J, Elkins M. Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. J Physiother. 2011;57(4):213-21. doi: 10.1016/S1836-9553(11)70051-0.
PubMed 22093119Bonnevie T, Villiot-Danger JC, Gravier FE, Dupuis J, Prieur G, Medrinal C. Inspiratory muscle training is used in some intensive care units, but many training methods have uncertain efficacy: a survey of French physiotherapists. J Physiother. 2015 Oct;61(4):204-9. doi: 10.1016/j.jphys.2015.08.003. Epub 2015 Sep 11.
PubMed 26365266Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
PubMed 30007823Tonella RM, Ratti LDSR, Delazari LEB, Junior CF, Da Silva PL, Herran ARDS, Dos Santos Faez DC, Saad IAB, De Figueiredo LC, Moreno R, Dragosvac D, Falcao ALE. Inspiratory Muscle Training in the Intensive Care Unit: A New Perspective. J Clin Med Res. 2017 Nov;9(11):929-934. doi: 10.14740/jocmr3169w. Epub 2017 Oct 2.
PubMed 29038671Condessa RL, Brauner JS, Saul AL, Baptista M, Silva AC, Vieira SR. Inspiratory muscle training did not accelerate weaning from mechanical ventilation but did improve tidal volume and maximal respiratory pressures: a randomised trial. J Physiother. 2013 Jun;59(2):101-7. doi: 10.1016/S1836-9553(13)70162-0.
PubMed 23663795Bissett B, Leditschke IA, Green M. Specific inspiratory muscle training is safe in selected patients who are ventilator-dependent: a case series. Intensive Crit Care Nurs. 2012 Apr;28(2):98-104. doi: 10.1016/j.iccn.2012.01.003. Epub 2012 Feb 15.
PubMed 22340987Sassoon CS, Caiozzo VJ, Manka A, Sieck GC. Altered diaphragm contractile properties with controlled mechanical ventilation. J Appl Physiol (1985). 2002 Jun;92(6):2585-95. doi: 10.1152/japplphysiol.01213.2001.
PubMed 12015377Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Hudson MB, Smuder AJ, Nelson WB, Bruells CS, Levine S, Powers SK. Both high level pressure support ventilation and controlled mechanical ventilation induce diaphragm dysfunction and atrophy. Crit Care Med. 2012 Apr;40(4):1254-60. doi: 10.1097/CCM.0b013e31823c8cc9.
PubMed 22425820Silva PE. Inspiratory muscle training in mechanical ventilation: suitable protocols and endpoints, the key to clear results - a critical review. ASSOBRAFIR Ciência. 2015;6(1):21-30
Elbouhy MS, AbdelHalim HA, Hashem AMA. Effect of respiratory muscles training in weaning of mechanically ventilated COPD patients. Egypt J Chest Dis Tuberc. 2014;63(3):679-87
Bissett B, Leditschke IA. Inspiratory muscle training to enhance weaning from mechanical ventilation. Anaesth Intensive Care. 2007 Oct;35(5):776-9. doi: 10.1177/0310057X0703500520.
PubMed 17933168Sprague SS, Hopkins PD. Use of inspiratory strength training to wean six patients who were ventilator-dependent. Phys Ther. 2003 Feb;83(2):171-81.
PubMed 12564952Cader SA, Vale RG, Castro JC, Bacelar SC, Biehl C, Gomes MC, Cabrer WE, Dantas EH. Inspiratory muscle training improves maximal inspiratory pressure and may assist weaning in older intubated patients: a randomised trial. J Physiother. 2010;56(3):171-7. doi: 10.1016/s1836-9553(10)70022-9.
PubMed 20795923
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning Admitted in the Intensive Care Unit?
- ClinicalTrials.gov ID
- NCT04347317
- Acronym / sponsor ID
- PR(ATR)03/2020
- Conditions
- Weaning Failure
- Keywords
- mechanical ventilator weaning, mechanical ventilation, difficult weaning, intensive care unit, inspiratory muscle training, ventilator-induced diaphragmatic dysfunction, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Apr 2020 (actual)
- 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 has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longer duration of mechanical ventilation and increased risk of complications and death. Consequently, the duration of stay in ICU is longer and the costs in ICU increase.
Objectives: To determine the effects of a high intensity inspiratory muscle training (IMT) on inspiratory muscle strength, weaning outcomes, complications and length of stay in the ICU in medical patients with difficulty on weaning and admitted in the ICU.
Methodology: In a single blind randomized clinical trial, 40 tracheotomy ventilated medical patients in which spontaneous breathing trial has failed ≥ 1 time, will be selected and randomized into two equitable groups. In the intervention group, IMT will be performed at 60% of the maximum inspiratory pressure (which will increase by 10% every week) while in the control group it will be performed at 30%. In both groups, 5 sets of 6 breaths will be performed, once a day, 5 days a week, for a maximum of 28 days or until the patient is successfully weaned. The main outcome will be the maximum inspiratory pressure, while the maximum expiratory pressure, weaning duration process, weaning success, duration of mechanical ventilation, length of stay in the ICU, complications and the rapid shallow breathing index will be analyzed as secondary outcomes.
t-student test for independent samples will be used to analyze quantitative outcomes. For qualitative outcomes will be used X2 test. A value of p<0.05 will be assumed as an indicator of statistically significant results.
Future contributions: Our collect results can be useful for the updating of the clinical practice guidelines and promote its implementation in the clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity IMT | Active comparator | Procedure: Low Intensity IMT |
| High Intensity IMT | Experimental | Procedure: High Intensity IMT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Medical patients aged ≥ 18 years hospitalized in the ICU.
- Patients ventilated by tracheostomy and who have failed ≥ 1 spontaneous breathing test.
- Being ventilated in assisted-controlled, assisted or pressure support modes.
- PEEP ≤ 10 cmH2O
- Richmond Agitation-Sedation Scale between -1 and 0.
Key exclusion criteria (16 listed)
- Progressive neuromuscular disease
- Thoraco-abdominal surgery in a period <30 days from the beginning of the study.
- Diseases that cause hemodynamic instability (cardiac arrhythmia, decompensated heart failure, unstable ischemic heart disease).
- Hemoptysis
- Unstable chest wall.
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 |
|---|---|---|
| Low Intensity IMTThe control group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 30% of the MIP and will be increased by 10% of the initial MIP weekly. The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity. | Procedure or surgery | Low Intensity IMT |
| High Intensity IMTThe experimental group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 60% of the MIP and will be increased by 10% of the initial MIP weekly. The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity. | Procedure or surgery | High Intensity IMT |
Primary outcome
Inspiratory muscle strength
Time frame: Through study completion, an average of 28 days
Measured with MIP (Maximal Inspiratory Pressure) Assessments: Baseline, after the intervention period
7 secondary outcomes
Expiratory muscle strength
Time frame: Through study completion, an average of 28 days
Rapid Shallow Breathing Index
Time frame: Through study completion, an average of 28 days
Duration of the weaning period
Time frame: Through study completion, an average of 28 days
Weaning success
Time frame: Through study completion, an average of 28 days
Duration of mechanical ventilation
Time frame: Through study completion, an average of 28 days
Length of stay in the ICU
Time frame: Through study completion, an average of 28 days
Complications
Time frame: Through study completion, an average of 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- BackgroundDixit A, Prakash S. Effects of threshold inspiratory muscle training versus conventional physiotherapy on the weaning period of mechanically ventilated patients: a comparative study. Int J Physiother Res. 2014;2(2):424-8
- Background: PubMed 22093119Moodie L, Reeve J, Elkins M. Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. J Physiother. 2011;57(4):213-21. doi: 10.1016/S1836-9553(11)70051-0.
- Background: PubMed 26365266Bonnevie T, Villiot-Danger JC, Gravier FE, Dupuis J, Prieur G, Medrinal C. Inspiratory muscle training is used in some intensive care units, but many training methods have uncertain efficacy: a survey of French physiotherapists. J Physiother. 2015 Oct;61(4):204-9. doi: 10.1016/j.jphys.2015.08.003. Epub 2015 Sep 11.
- Background: PubMed 30007823Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.
- Background: PubMed 29038671Tonella RM, Ratti LDSR, Delazari LEB, Junior CF, Da Silva PL, Herran ARDS, Dos Santos Faez DC, Saad IAB, De Figueiredo LC, Moreno R, Dragosvac D, Falcao ALE. Inspiratory Muscle Training in the Intensive Care Unit: A New Perspective. J Clin Med Res. 2017 Nov;9(11):929-934. doi: 10.14740/jocmr3169w. Epub 2017 Oct 2.
- Background: PubMed 23663795Condessa RL, Brauner JS, Saul AL, Baptista M, Silva AC, Vieira SR. Inspiratory muscle training did not accelerate weaning from mechanical ventilation but did improve tidal volume and maximal respiratory pressures: a randomised trial. J Physiother. 2013 Jun;59(2):101-7. doi: 10.1016/S1836-9553(13)70162-0.
- Background: PubMed 22340987Bissett B, Leditschke IA, Green M. Specific inspiratory muscle training is safe in selected patients who are ventilator-dependent: a case series. Intensive Crit Care Nurs. 2012 Apr;28(2):98-104. doi: 10.1016/j.iccn.2012.01.003. Epub 2012 Feb 15.
- Background: PubMed 12015377Sassoon CS, Caiozzo VJ, Manka A, Sieck GC. Altered diaphragm contractile properties with controlled mechanical ventilation. J Appl Physiol (1985). 2002 Jun;92(6):2585-95. doi: 10.1152/japplphysiol.01213.2001.
- Background: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Background: PubMed 22425820Hudson MB, Smuder AJ, Nelson WB, Bruells CS, Levine S, Powers SK. Both high level pressure support ventilation and controlled mechanical ventilation induce diaphragm dysfunction and atrophy. Crit Care Med. 2012 Apr;40(4):1254-60. doi: 10.1097/CCM.0b013e31823c8cc9.
- BackgroundSilva PE. Inspiratory muscle training in mechanical ventilation: suitable protocols and endpoints, the key to clear results - a critical review. ASSOBRAFIR Ciência. 2015;6(1):21-30
- BackgroundElbouhy MS, AbdelHalim HA, Hashem AMA. Effect of respiratory muscles training in weaning of mechanically ventilated COPD patients. Egypt J Chest Dis Tuberc. 2014;63(3):679-87
- 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.
Bernat Planas Pascual, PT,MSc principal investigator
Hospital Universitari Vall d'Hebron Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity IMT and High Intensity IMT in people with Weaning Failure, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
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 10 inclusion and 16 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Esther Batlle Borraz, PT (+34697964618, esther.batlle.borraz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: Through study completion, an average of 28 days). 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 NCT04347317, which also lists 26 linked publications.
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 19 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.