Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training

NCT05710432 | Recruiting

• 1 other identifier: 22-185
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mechanical Ventilator Weaning; Respiratory Muscle Training

Keywords

Mechanical Ventilation; Inspiratory Muscle Training; Neck Flexion; Mechanical Ventilator Weaning

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

Study Arms (2)

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.

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.

Other: Quasi-Isometric Neck Flexion; Other: Inspiratory Muscle Training

Interventions

Quasi-Isometric Neck Flexion OTHER

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 Training; Quasi-Isometric Neck Flexion

Inspiratory Muscle Training OTHER

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.

Inspiratory Muscle Training; Quasi-Isometric Neck Flexion

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (38)

• 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.

  PMID: 27626706 BACKGROUND

• Boles 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.

  PMID: 17470624 BACKGROUND

• Funk 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.

  PMID: 19541716 BACKGROUND

• Herridge 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.

  PMID: 26974173 BACKGROUND

• Unroe 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.

  PMID: 20679561 BACKGROUND

• Damuth 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.

  PMID: 26003390 BACKGROUND

• Claxton 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.

  PMID: 9512849 BACKGROUND

• Dres 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.

  PMID: 27310484 BACKGROUND

• Kim 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.

  PMID: 21705883 BACKGROUND

• Jung 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.

  PMID: 26572511 BACKGROUND

• Goligher 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.

  PMID: 28930478 BACKGROUND

• Goligher 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.

  PMID: 26167730 BACKGROUND

• Dres 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.

  PMID: 28917004 BACKGROUND

• Vorona 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.

  PMID: 29584447 BACKGROUND

• Elkins 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.

  PMID: 26092389 BACKGROUND

• Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.

  PMID: 21385346 BACKGROUND

• Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.

  PMID: 21282809 BACKGROUND

• Hoffman M, Van Hollebeke M, Clerckx B, Muller J, Louvaris Z, Gosselink R, Hermans G, Langer D. Can inspiratory muscle training improve weaning outcomes in difficult to wean patients? A protocol for a randomised controlled trial (IMweanT study). BMJ Open. 2018 Jun 30;8(6):e021091. doi: 10.1136/bmjopen-2017-021091.

  PMID: 29961023 BACKGROUND

• De Troyer A, Estenne M. Coordination between rib cage muscles and diaphragm during quiet breathing in humans. J Appl Physiol Respir Environ Exerc Physiol. 1984 Sep;57(3):899-906. doi: 10.1152/jappl.1984.57.3.899.

  PMID: 6238017 BACKGROUND

• De Troyer A, Boriek AM. Mechanics of the respiratory muscles. Compr Physiol. 2011 Jul;1(3):1273-300. doi: 10.1002/cphy.c100009.

  PMID: 23733642 BACKGROUND

• Shi ZH, Jonkman A, de Vries H, Jansen D, Ottenheijm C, Girbes A, Spoelstra-de Man A, Zhou JX, Brochard L, Heunks L. Expiratory muscle dysfunction in critically ill patients: towards improved understanding. Intensive Care Med. 2019 Aug;45(8):1061-1071. doi: 10.1007/s00134-019-05664-4. Epub 2019 Jun 24.

  PMID: 31236639 BACKGROUND

• Laghi F, Shaikh HS, Morales D, Sinderby C, Jubran A, Tobin MJ. Diaphragmatic neuromechanical coupling and mechanisms of hypercapnia during inspiratory loading. Respir Physiol Neurobiol. 2014 Jul 1;198:32-41. doi: 10.1016/j.resp.2014.03.004. Epub 2014 Apr 16.

  PMID: 24747754 BACKGROUND

• Ishida H, Suehiro T, Kurozumi C, Ono K, Watanabe S. Correlation Between Abdominal Muscle Thickness and Maximal Expiratory Pressure. J Ultrasound Med. 2015 Nov;34(11):2001-5. doi: 10.7863/ultra.14.12006. Epub 2015 Sep 22.

  PMID: 26396169 BACKGROUND

• Dres M, Dube BP, Goligher E, Vorona S, Demiri S, Morawiec E, Mayaux J, Brochard L, Similowski T, Demoule A. Usefulness of Parasternal Intercostal Muscle Ultrasound during Weaning from Mechanical Ventilation. Anesthesiology. 2020 May;132(5):1114-1125. doi: 10.1097/ALN.0000000000003191.

  PMID: 32084029 BACKGROUND

• Shi ZH, de Vries H, de Grooth HJ, Jonkman AH, Zhang Y, Haaksma M, van de Ven PM, de Man AAME, Girbes A, Tuinman PR, Zhou JX, Ottenheijm C, Heunks L. Changes in Respiratory Muscle Thickness during Mechanical Ventilation: Focus on Expiratory Muscles. Anesthesiology. 2021 May 1;134(5):748-759. doi: 10.1097/ALN.0000000000003736.

  PMID: 33711154 BACKGROUND

• Vivier E, Roussey A, Doroszewski F, Rosselli S, Pommier C, Carteaux G, Mekontso Dessap A. Atrophy of Diaphragm and Pectoral Muscles in Critically Ill Patients. Anesthesiology. 2019 Sep;131(3):569-579. doi: 10.1097/ALN.0000000000002737.

  PMID: 31094757 BACKGROUND

• Schreiber AF, Bertoni M, Coiffard B, Fard S, Wong J, Reid WD, Brochard LJ, Piva S, Goligher EC. Abdominal Muscle Use During Spontaneous Breathing and Cough in Patients Who Are Mechanically Ventilated: A Bi-center Ultrasound Study. Chest. 2021 Oct;160(4):1316-1325. doi: 10.1016/j.chest.2021.05.053. Epub 2021 Jun 6.

  PMID: 34090872 BACKGROUND

• Enriquez D, Gomez Traverso R, Brizuela S, Szyld E. [Mistakes in drug prescription during simulated pediatric resuscitations and other urgency procedures]. Arch Argent Pediatr. 2017 Jun 1;115(3):294-299. doi: 10.5546/aap.2017.294. Spanish.

  PMID: 28504508 BACKGROUND

• DePalo VA, Parker AL, Al-Bilbeisi F, McCool FD. Respiratory muscle strength training with nonrespiratory maneuvers. J Appl Physiol (1985). 2004 Feb;96(2):731-4. doi: 10.1152/japplphysiol.00511.2003. Epub 2003 Sep 26.

  PMID: 14514702 BACKGROUND

• Derbakova A, Khuu S, Ho K, Lewis C, Ma T, Melo LT, Zabjek KF, Goligher EC, Brochard L, Fregonezi G, Reid WD. Neck and Inspiratory Muscle Recruitment during Inspiratory Loading and Neck Flexion. Med Sci Sports Exerc. 2020 Jul;52(7):1610-1616. doi: 10.1249/MSS.0000000000002271.

  PMID: 31977643 BACKGROUND

• Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):642-9. doi: 10.1007/s00134-015-3687-3. Epub 2015 Feb 19.

  PMID: 25693448 BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

• Formenti P, Umbrello M, Dres M, Chiumello D. Ultrasonographic assessment of parasternal intercostal muscles during mechanical ventilation. Ann Intensive Care. 2020 Sep 7;10(1):120. doi: 10.1186/s13613-020-00735-y.

  PMID: 32894372 BACKGROUND

• Hong BY, Ko YJ, Kim JS, Ok EJ, Hwang Y, Kim HW. Sternocleidomastoid ultrasonography data for muscular torticollis in infants. Muscle Nerve. 2013 Jul;48(1):100-4. doi: 10.1002/mus.23712. Epub 2013 Apr 21.

  PMID: 23605885 BACKGROUND

• Kubas C, Chen YW, Echeverri S, McCann SL, Denhoed MJ, Walker CJ, Kennedy CN, Reid WD. Reliability and Validity of Cervical Range of Motion and Muscle Strength Testing. J Strength Cond Res. 2017 Apr;31(4):1087-1096. doi: 10.1519/JSC.0000000000001578.

  PMID: 27467513 BACKGROUND

• Marini JJ, Smith TC, Lamb V. Estimation of Inspiratory Muscle Strength in Mechanically Ventilated Patients: The Measurement of Maxima Inspiratory Pressure. J Crit Care. 1986;1(1):32-8.

  BACKGROUND

• de Almeida LB, Trevizan PF, Laterza MC, Hallack Neto AE, Perrone ACASJ, Martinez DG. Safety and feasibility of inspiratory muscle training for hospitalized patients undergoing hematopoietic stem cell transplantation: a randomized controlled study. Support Care Cancer. 2020 Aug;28(8):3627-3635. doi: 10.1007/s00520-019-05209-x. Epub 2019 Dec 5.

  PMID: 31807987 BACKGROUND

• Fioritto AP, Oliveira CC, Albuquerque VS, Almeida LB, Granger CL, Denehy L, Malaguti C. Individualized in-hospital exercise training program for people undergoing hematopoietic stem cell transplantation: a feasibility study. Disabil Rehabil. 2021 Feb;43(3):386-392. doi: 10.1080/09638288.2019.1626493. Epub 2019 Jun 11.

  PMID: 31184516 BACKGROUND

Central Study Contacts

Laurent Brochard, MD, PhD

CONTACT

416-864-5686; Laurent.Brochard@unityhealth.to

Annia Schreiber, MD

CONTACT

annia.schreiber@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The two training techniques will be randomized using sealed opaque envelopes.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: February 2, 2023
• Study Start: February 9, 2023
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)