Mechanical Ventilator WeaningFLEXNCT05710432
Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training
A study testing Quasi-Isometric Neck Flexion and Inspiratory Muscle Training in people with Mechanical Ventilator Weaning and Respiratory Muscle Training, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Respiratory muscle dysfunction is highly prevalent in patients with prolonged weaning from mechanical ventilation and is strongly associated with weaning failure. Efforts to strengthen the respiratory muscles, aimed at reversing or minimizing the impact of respiratory muscle weakness on clinical outcomes, have… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Mechanical Ventilator Weaning, Respiratory Muscle Training
- What is being tested?
- Quasi-Isometric Neck Flexion and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 9 Feb 2023to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving invasive MV via endotracheal tube who had failed a planned extubation or failed at least three spontaneous breathing trials (SBTs) or receiving MV via tracheostomy (who required tracheostomy because of difficult or prolonged weaning, failed extubation and/or prolonged ventilation) and able to spontaneously trigger the ventilator.
- Over or equal to 16 years of age
- Tolerating levels of pressure support of 10 cmH2O or lower (or equivalent support in NAVA or PAV+) for at least 15 minutes
- In stable clinical and hemodynamic conditions and adequate level of oxygenation (cardiac frequency ≤ 140 beats/minute, systolic blood pressure 90-160 mmHg, no or minimal vasopressors, PaO2/FiO2 over or equal to 150 mmHg)
- Able to understand and follow simple verbal instructions
Who cannot join
- Patients with a previously diagnosed severe neuromuscular disorder (such as amyotrophic lateral sclerosis, muscular dystrophy, multiple sclerosis, myasthenia gravis or spinal cord injury)
- Patients with chronic respiratory failure already ventilated before ICU admission
- Patients unable to collaborate or understand instructions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annia Schreiber, MD contact
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Laurent Brochard, MD, MD, HDR, 4168645686, laurent.brochard@unityhealth.to
Annia Schreiber
About this study
Official title: Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training in Difficult and Prolonged Weaning Patients: a Physiological Study - The FLEX Study
Respiratory muscle dysfunction is highly prevalent in patients with prolonged weaning from mechanical ventilation and is strongly associated with weaning failure. Efforts to strengthen the respiratory muscles, aimed at reversing or minimizing the impact of respiratory muscle weakness on clinical outcomes, have generally focused on the diaphragm with specific inspiratory muscle training (IMT) exercises. However, the effectiveness of these exercises and impact on clinical outcomes are not current practice in the majority of ICUs, as they are hardly feasible in ICU patients who often cannot be disconnected from the ventilator and cannot fully cooperate.
Promising results have been published concerning non-respiratory training techniques, which can also target the accessory muscles, particularly important in the presence of increased load to the respiratory system, as in the case of the weaning phase. These non-respiratory training techniques would have the advantage of not entailing disconnection of the patient from the ventilator. In particular, in healthy subjects, a quasi-isometric neck contraction, called neck flexion, appeared to generate greater or comparable recruitment of some principal and accessory muscles of respiration, when compared to conventional IMT. However, this has not been studied in patients requiring prolonged mechanical ventilation, for whom IMT with threshold loading devices remains the primary recommended rehabilitation strategy.
Read more
Therefore, the primary aim of the investigators is to assess the feasibility, tolerability, and safety of neck flexion and to compare them with IMT technique in patients with difficult and prolonged weaning from mechanical ventilation. Secondary aims are: i) to characterize which respiratory muscles are recruited and their level of activation at different levels of ventilatory assistance and ii) to assess which respiratory muscles are recruited and their level of activation during the two techniques and to compare these findings.
The hypothesis of the investigators is that neck flexion will be feasible (more than conventional IMT), well tolerated, and safe in patients with difficult and prolonged weaning. The investigators also hypothesize that, reducing the level of assistance and during unassisted breathing, a progressively increasing activation of the diaphragm, neck and trunk respiratory muscles, reflecting increased ventilatory load, will be fund. Finally, the hypothesis of the investigators is that the level of muscle activation/recruitment during neck flexion will be comparable or even greater to that occurring during IMT, as found in healthy subjects.
Finding a new and highly feasible rehabilitative technique, able to recruit and train the respiratory muscles (including accessory muscles), will have the potential to promote patients' weaning and improve all related clinical outcomes, and therefore to dramatically shift the paradigm about the role of rehabilitation in ICU.
Read the detailed description
The investigators will conduct a prospective longitudinal pilot study in patients receiving mechanical ventilation via endotracheal tube or tracheostomy.
The investigators will perform a set of baseline measurements (as early as possible after the patient reaches the ability to spontaneously trigger the ventilator).These measurements include: I) ultrasound measurements (thickness and thickening fraction) of the diaphragm, parasternal intercostals, sternocleidomastoid and of the abdominal muscles; II) surface electromyography (sEMG) of the diaphragm, sternocleidomastoid, scalene, and of the abdominal muscles. Ultrasound and sEMG measurements will be performed during the current level of ventilation (decided by the clinical team), during minimal level of ventilatory support and/or during unassisted breathing; III) maximal inspiratory pressure (MIP); IV) maximal voluntary contraction (MVC) of neck flexion.
As soon as patients can be disconnected from the ventilator I) IMT maneuvers and II) neck flexion maneuvers, will be started and performed once a week (each time in a randomized order), until patients are successfully weaned or for a maximum of 4 weeks. The investigators will also perform: III) ultrasound measurements; IV) surface electromyography of the muscles above specified during each IMT and neck flexion maneuver; V) MIP and MVC; these latter measurements will be repeated weekly and inspiratory muscle training and neck flexion intensity level targeted accordingly.
- Being tested
- Quasi-Isometric Neck Flexion, Inspiratory Muscle Training
- Keywords
- Mechanical Ventilation, Inspiratory Muscle Training, Neck Flexion, Mechanical Ventilator Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quasi-Isometric Neck FlexionOther
Patients will be asked to minimally lift their head from the pillow generating a quasi-isometric neck contraction (2 sets of 6-10 flexions).
Inspiratory Muscle TrainingOther
Patients will be asked to complete 2 sets of 6-10 breaths through a POWERbreathe device, which applies a variable resistance provided by an electronically controlled valve (variable flow resistive load).
During each IMT and neck flexion maneuver ultrasound measurements will be performed (measurements of the diaphragm, sternocleidomastoid, parasternal intercostal, internal oblique [IO], external oblique [EO], transversus abdominis [TrA] and rectus abdominis [RA] will be taken) and, during the entire period, sEMG monitoring of the target muscles (diaphragm, sternocleidomastoid, parasternal intercostal and EO) will be continued.
| Study group | Role | What they receive |
|---|---|---|
| Quasi-Isometric Neck Flexion | Experimental | On minimal mechanical ventilation support (unassisted/assisted spontaneous breathing) via tracheostomy.
Quasi-Isometric Neck Flexion will be performed during mechanical ventilation. Patients will be asked to minimally lift their head from the pillow generating a quasi-isometric neck contraction. 30% will be the target intensity level for neck flexion. The patient will perform 2 sets of 6-10 quasi-isometric neck flexions. Receives: Other: Quasi-Isometric Neck Flexion; Other: Inspiratory Muscle Training |
| Inspiratory Muscle Training | Experimental | Perform 2 sets of 6-10 breaths through a POWERbreathe device, which applies a variable resistance provided by an electronically controlled valve (variable flow resistive load). The training device will be set at 30% of the highest value of three MIP maneuvers. A two-minute rest period with MV support will be provided between each set. Receives: Other: Quasi-Isometric Neck Flexion; Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the training techniques
Adherence to neck flexion and inspiratory muscle training techniques (minimum 70% completion), corresponding to the number of training sessions divided by the total number of potential sessions.
Measured: Baseline measurements assessed ≤ 72 hours from admission and once a week until successfully weaned or up to maximum of 4 weeks.
Incidence of Treatment-Emergent Adverse Events
Neck flexion and IMT will be considered well tolerated if < 10% of patients refers dyspnea > 6 on the Borg scale (Borg scale minimum value is 0, which corresponds to no breathlessness at all; maximum value is 10, corresponding to the most severe breathlessness ever experienced or could imagine experiencing), or severe musculoskeletal soreness, during/after the training techniques.
Neck flexion and IMT will be considered safe if < 5% of adverse events will be observed during/after the training techniques. Will be considered adverse events: desaturation over 4%, systolic blood pressure >180 mmHg or <90 mmHg or increased over or equal to 20%, cardiac arrhythmias, heart rate >140 beats/min or increased over or equal to 20%, respiratory rate >35 breaths/min or increased over or equal to 50%, cyanosis, diaphoresis, dizziness, facial signs of distress, evidence of increasing accessory muscle activity.
Measured: Baseline measurements assessed ≤ 72 hours from admission and once a week until successfully weaned or up to maximum of 4 weeks.
Secondary outcomes (4)
Level of activation of the different respiratory muscles at different levels of ventilatory assistance through surface EMG
- To compare the level of activation during usual ventilatory setting vs minimal level of assistance/unassisted breathing paired t-test or Wilcoxon test will be performed.
Measured: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Level of activation of the different respiratory muscles at different levels of ventilatory assistance through ultrasound
- To compare the level of activation during usual ventilatory setting vs minimal level of assistance/unassisted breathing paired t-test or Wilcoxon test will be performed.
Measured: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Level of activation of the different respiratory muscles during the two training techniques (quasi-isometric neck flexion and IMT) through surface EMG
- To compare the degree of activation during IMT and neck flexion paired t-test or Wilcoxon test will be performed.
Measured: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Level of activation of the different respiratory muscles during the two training techniques (quasi-isometric neck flexion and IMT) through ultrasound
- To compare the degree of activation during IMT and neck flexion paired t-test or Wilcoxon test will be performed.
Measured: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start9 Feb 2023
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- As soon as patients can be disconnected from the ventilator and able to perform IMT, the order of the two training techniques (Quasi-isometric neck flexion exercise and inspiratory muscle training) will be randomized (using sealed opaque envelopes).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710432
- Sponsor's protocol ID
- 22-185
- Acronym
- FLEX
- Status last verified
- May 2025
- First submitted
- 19 Dec 2022
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
PubMed 27626706Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624Funk GC, Anders S, Breyer MK, Burghuber OC, Edelmann G, Heindl W, Hinterholzer G, Kohansal R, Schuster R, Schwarzmaier-D'Assie A, Valentin A, Hartl S. Incidence and outcome of weaning from mechanical ventilation according to new categories. Eur Respir J. 2010 Jan;35(1):88-94. doi: 10.1183/09031936.00056909. Epub 2009 Jun 18.
PubMed 19541716Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, Santos CD, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Cameron JI; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. The RECOVER Program: Disability Risk Groups and 1-Year Outcome after 7 or More Days of Mechanical Ventilation. Am J Respir Crit Care Med. 2016 Oct 1;194(7):831-844. doi: 10.1164/rccm.201512-2343OC.
PubMed 26974173Unroe M, Kahn JM, Carson SS, Govert JA, Martinu T, Sathy SJ, Clay AS, Chia J, Gray A, Tulsky JA, Cox CE. One-year trajectories of care and resource utilization for recipients of prolonged mechanical ventilation: a cohort study. Ann Intern Med. 2010 Aug 3;153(3):167-75. doi: 10.7326/0003-4819-153-3-201008030-00007.
PubMed 20679561Damuth E, Mitchell JA, Bartock JL, Roberts BW, Trzeciak S. Long-term survival of critically ill patients treated with prolonged mechanical ventilation: a systematic review and meta-analysis. Lancet Respir Med. 2015 Jul;3(7):544-53. doi: 10.1016/S2213-2600(15)00150-2. Epub 2015 May 20.
PubMed 26003390Claxton AR, Wong DT, Chung F, Fehlings MG. Predictors of hospital mortality and mechanical ventilation in patients with cervical spinal cord injury. Can J Anaesth. 1998 Feb;45(2):144-9. doi: 10.1007/BF03013253.
PubMed 9512849Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
PubMed 27310484Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
PubMed 21705883Jung B, Moury PH, Mahul M, de Jong A, Galia F, Prades A, Albaladejo P, Chanques G, Molinari N, Jaber S. Diaphragmatic dysfunction in patients with ICU-acquired weakness and its impact on extubation failure. Intensive Care Med. 2016 May;42(5):853-861. doi: 10.1007/s00134-015-4125-2. Epub 2015 Nov 16.
PubMed 26572511Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
PubMed 28930478Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.
PubMed 26167730Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.
PubMed 28917004Vorona S, Sabatini U, Al-Maqbali S, Bertoni M, Dres M, Bissett B, Van Haren F, Martin AD, Urrea C, Brace D, Parotto M, Herridge MS, Adhikari NKJ, Fan E, Melo LT, Reid WD, Brochard LJ, Ferguson ND, Goligher EC. Inspiratory Muscle Rehabilitation in Critically Ill Adults. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2018 Jun;15(6):735-744. doi: 10.1513/AnnalsATS.201712-961OC.
PubMed 29584447Elkins M, Dentice R. Inspiratory muscle training facilitates weaning from mechanical ventilation among patients in the intensive care unit: a systematic review. J Physiother. 2015 Jul;61(3):125-34. doi: 10.1016/j.jphys.2015.05.016. Epub 2015 Jun 16.
PubMed 26092389
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training in Difficult and Prolonged Weaning Patients: a Physiological Study - The FLEX Study
- ClinicalTrials.gov ID
- NCT05710432
- Acronym / sponsor ID
- FLEX / 22-185
- Keywords
- Mechanical Ventilation, Inspiratory Muscle Training, Neck Flexion, Mechanical Ventilator Weaning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 2 Feb 2023 (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.
Respiratory muscle dysfunction is highly prevalent in patients with prolonged weaning from mechanical ventilation and is strongly associated with weaning failure. Efforts to strengthen the respiratory muscles, aimed at reversing or minimizing the impact of respiratory muscle weakness on clinical outcomes, have generally focused on the diaphragm with specific inspiratory muscle training (IMT) exercises. However, the effectiveness of these exercises and impact on clinical outcomes are not current practice in the majority of ICUs, as they are hardly feasible in ICU patients who often cannot be disconnected from the ventilator and cannot fully cooperate.
Promising results have been published concerning non-respiratory training techniques, which can also target the accessory muscles, particularly important in the presence of increased load to the respiratory system, as in the case of the weaning phase. These non-respiratory training techniques would have the advantage of not entailing disconnection of the patient from the ventilator. In particular, in healthy subjects, a quasi-isometric neck contraction, called neck flexion, appeared to generate greater or comparable recruitment of some principal and accessory muscles of respiration, when compared to conventional IMT. However, this has not been studied in patients requiring prolonged mechanical ventilation, for whom IMT with threshold loading devices remains the primary recommended rehabilitation strategy.
Therefore, the primary aim of the investigators is to assess the feasibility, tolerability, and safety of neck flexion and to compare them with IMT technique in patients with difficult and prolonged weaning from mechanical ventilation. Secondary aims are: i) to characterize which respiratory muscles are recruited and their level of activation at different levels of ventilatory assistance and ii) to assess which respiratory muscles are recruited and their level of activation during the two techniques and to compare these findings.
The hypothesis of the investigators is that neck flexion will be feasible (more than conventional IMT), well tolerated, and safe in patients with difficult and prolonged weaning. The investigators also hypothesize that, reducing the level of assistance and during unassisted breathing, a progressively increasing activation of the diaphragm, neck and trunk respiratory muscles, reflecting increased ventilatory load, will be fund. Finally, the hypothesis of the investigators is that the level of muscle activation/recruitment during neck flexion will be comparable or even greater to that occurring during IMT, as found in healthy subjects.
Finding a new and highly feasible rehabilitative technique, able to recruit and train the respiratory muscles (including accessory muscles), will have the potential to promote patients' weaning and improve all related clinical outcomes, and therefore to dramatically shift the paradigm about the role of rehabilitation in ICU.
Detailed description
The investigators will conduct a prospective longitudinal pilot study in patients receiving mechanical ventilation via endotracheal tube or tracheostomy.
The investigators will perform a set of baseline measurements (as early as possible after the patient reaches the ability to spontaneously trigger the ventilator).These measurements include: I) ultrasound measurements (thickness and thickening fraction) of the diaphragm, parasternal intercostals, sternocleidomastoid and of the abdominal muscles; II) surface electromyography (sEMG) of the diaphragm, sternocleidomastoid, scalene, and of the abdominal muscles. Ultrasound and sEMG measurements will be performed during the current level of ventilation (decided by the clinical team), during minimal level of ventilatory support and/or during unassisted breathing; III) maximal inspiratory pressure (MIP); IV) maximal voluntary contraction (MVC) of neck flexion.
As soon as patients can be disconnected from the ventilator I) IMT maneuvers and II) neck flexion maneuvers, will be started and performed once a week (each time in a randomized order), until patients are successfully weaned or for a maximum of 4 weeks. The investigators will also perform: III) ultrasound measurements; IV) surface electromyography of the muscles above specified during each IMT and neck flexion maneuver; V) MIP and MVC; these latter measurements will be repeated weekly and inspiratory muscle training and neck flexion intensity level targeted accordingly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- As soon as patients can be disconnected from the ventilator and able to perform IMT, the order of the two training techniques (Quasi-isometric neck flexion exercise and inspiratory muscle training) will be randomized (using sealed opaque envelopes).
| Arm | Type | Receives |
|---|---|---|
| Quasi-Isometric Neck Flexion | Experimental | Other: Quasi-Isometric Neck Flexion, Other: Inspiratory Muscle TrainingOn minimal mechanical ventilation support (unassisted/assisted spontaneous breathing) via tracheostomy. Quasi-Isometric Neck Flexion will be performed during mechanical ventilation. Patients will be asked to minimally lift their head from the pillow generating a quasi-isometric neck contraction. 30% will be the target intensity level for neck flexion. The patient will perform 2 sets of 6-10 quasi-isometric neck flexions. |
| Inspiratory Muscle Training | Experimental | Other: Quasi-Isometric Neck Flexion, Other: Inspiratory Muscle TrainingPerform 2 sets of 6-10 breaths through a POWERbreathe device, which applies a variable resistance provided by an electronically controlled valve (variable flow resistive load). The training device will be set at 30% of the highest value of three MIP maneuvers. A two-minute rest period with MV support will be provided between each set. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients receiving invasive MV via endotracheal tube who had failed a planned extubation or failed at least three spontaneous breathing trials (SBTs) or receiving MV via tracheostomy (who required tracheostomy because of difficult or prolonged weaning, failed extubation and/or prolonged ventilation) and able to spontaneously trigger the ventilator.
- Over or equal to 16 years of age
- Tolerating levels of pressure support of 10 cmH2O or lower (or equivalent support in NAVA or PAV+) for at least 15 minutes
- In stable clinical and hemodynamic conditions and adequate level of oxygenation (cardiac frequency ≤ 140 beats/minute, systolic blood pressure 90-160 mmHg, no or minimal vasopressors, PaO2/FiO2 over or equal to 150 mmHg)
- Able to understand and follow simple verbal instructions
Key exclusion criteria (3 listed)
- Patients with a previously diagnosed severe neuromuscular disorder (such as amyotrophic lateral sclerosis, muscular dystrophy, multiple sclerosis, myasthenia gravis or spinal cord injury)
- Patients with chronic respiratory failure already ventilated before ICU admission
- Patients unable to collaborate or understand instructions
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 |
|---|---|---|
| Quasi-Isometric Neck FlexionPatients will be asked to minimally lift their head from the pillow generating a quasi-isometric neck contraction (2 sets of 6-10 flexions). | Other | Inspiratory Muscle Training, Quasi-Isometric Neck Flexion |
| Inspiratory Muscle TrainingPatients will be asked to complete 2 sets of 6-10 breaths through a POWERbreathe device, which applies a variable resistance provided by an electronically controlled valve (variable flow resistive load). During each IMT and neck flexion maneuver ultrasound measurements will be performed (measurements of the diaphragm, sternocleidomastoid, parasternal intercostal, internal oblique [IO], external oblique [EO], transversus abdominis [TrA] and rectus abdominis [RA] will be taken) and, during the entire period, sEMG monitoring of the target muscles (diaphragm, sternocleidomastoid, parasternal intercostal and EO) will be continued. | Other | Inspiratory Muscle Training, Quasi-Isometric Neck Flexion |
Primary outcome
Adherence to the training techniques
Time frame: Baseline measurements assessed ≤ 72 hours from admission and once a week until successfully weaned or up to maximum of 4 weeks.
Adherence to neck flexion and inspiratory muscle training techniques (minimum 70% completion), corresponding to the number of training sessions divided by the total number of potential sessions.
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline measurements assessed ≤ 72 hours from admission and once a week until successfully weaned or up to maximum of 4 weeks.
Neck flexion and IMT will be considered well tolerated if < 10% of patients refers dyspnea > 6 on the Borg scale (Borg scale minimum value is 0, which corresponds to no breathlessness at all; maximum value is 10, corresponding to the most severe breathlessness ever experienced or could imagine experiencing), or severe musculoskeletal soreness, during/after the training techniques. Neck flexion and IMT will be considered safe if < 5% of adverse events will be observed during/after the training techniques. Will be considered adverse events: desaturation over 4%, systolic blood pressure >180 mmHg or <90 mmHg or increased over or equal to 20%, cardiac arrhythmias, heart rate >140 beats/min or increased over or equal to 20%, respiratory rate >35 breaths/min or increased over or equal to 50%, cyanosis, diaphoresis, dizziness, facial signs of distress, evidence of increasing accessory muscle activity.
4 secondary outcomes
Level of activation of the different respiratory muscles at different levels of ventilatory assistance through surface EMG
Time frame: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Level of activation of the different respiratory muscles at different levels of ventilatory assistance through ultrasound
Time frame: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Level of activation of the different respiratory muscles during the two training techniques (quasi-isometric neck flexion and IMT) through surface EMG
Time frame: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Level of activation of the different respiratory muscles during the two training techniques (quasi-isometric neck flexion and IMT) through ultrasound
Time frame: As early as possible after reaching the ability to spontaneously trigger the ventilator and tolerate a pressure support value of 10 cmH2O or below for at least 15 minutes until successfully weaned or a maximum of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Background: PubMed 27626706Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
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- Background: PubMed 19541716Funk GC, Anders S, Breyer MK, Burghuber OC, Edelmann G, Heindl W, Hinterholzer G, Kohansal R, Schuster R, Schwarzmaier-D'Assie A, Valentin A, Hartl S. Incidence and outcome of weaning from mechanical ventilation according to new categories. Eur Respir J. 2010 Jan;35(1):88-94. doi: 10.1183/09031936.00056909. Epub 2009 Jun 18.
- Background: PubMed 26974173Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, Santos CD, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Cameron JI; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. The RECOVER Program: Disability Risk Groups and 1-Year Outcome after 7 or More Days of Mechanical Ventilation. Am J Respir Crit Care Med. 2016 Oct 1;194(7):831-844. doi: 10.1164/rccm.201512-2343OC.
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- Background: PubMed 27310484Dres M, Dube BP, Mayaux J, Delemazure J, Reuter D, Brochard L, Similowski T, Demoule A. Coexistence and Impact of Limb Muscle and Diaphragm Weakness at Time of Liberation from Mechanical Ventilation in Medical Intensive Care Unit Patients. Am J Respir Crit Care Med. 2017 Jan 1;195(1):57-66. doi: 10.1164/rccm.201602-0367OC.
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- 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.
Annia Schreiber, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quasi-Isometric Neck Flexion and Inspiratory Muscle Training in people with Mechanical Ventilator Weaning and Respiratory Muscle Training, run by Unity Health Toronto at 1 site in Canada.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 May 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Brochard, MD, PhD (416-864-5686, Laurent.Brochard@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the training techniques (time frame: Baseline measurements assessed ≤ 72 hours from admission and once a week until successfully weaned or up to maximum of 4 weeks.). The study lists 2 primary outcomes in all. 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 NCT05710432, which also lists 38 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 20 May 2025.