[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493843":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":66,"collaborators":23,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":23,"enrollmentInfo":78,"targetDuration":23,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":39,"whyStopped":23,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Quasi-Isometric Neck Flexion","EXPERIMENTAL","On minimal mechanical ventilation support (unassisted\u002Fassisted spontaneous breathing) via tracheostomy.\n\nQuasi-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.",[13,14],"Other: Quasi-Isometric Neck Flexion","Other: Inspiratory Muscle Training",{"label":16,"type":10,"description":17,"interventionNames":18},"Inspiratory Muscle Training","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.",[13,14],[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"Patients will be asked to minimally lift their head from the pillow generating a quasi-isometric neck contraction (2 sets of 6-10 flexions).",[16,9],null,{"type":6,"name":16,"description":25,"armGroupLabels":26,"otherNames":23},"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).\n\nDuring 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.",[16,9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":23,"email":32},"Laurent Brochard, MD, PhD","CONTACT","416-864-5686","Laurent.Brochard@unityhealth.to",{"name":34,"role":30,"phone":23,"phoneExt":23,"email":35},"Annia Schreiber, MD","annia.schreiber@unityhealth.to",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"St. Michael's Hospital","RECRUITING","Toronto","Ontario","M5B 1W8","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52,56,59,61,63],{"name":53,"role":30,"phone":54,"phoneExt":23,"email":55},"Laurent Brochard, MD, MD, HDR","4168645686","laurent.brochard@unityhealth.to",{"name":57,"role":58,"phone":23,"phoneExt":23,"email":23},"Annia Schreiber","SUB_INVESTIGATOR",{"name":60,"role":58,"phone":23,"phoneExt":23,"email":23},"Antenor Rodrigues",{"name":62,"role":58,"phone":23,"phoneExt":23,"email":23},"Vorakamol Phoophiboon",{"name":64,"role":65,"phone":23,"phoneExt":23,"email":23},"Laurent Brochard","PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100493843","muscle-recruitment-during-neck-flexion-and-inspiratory-muscle-training-100493843",false,"NCT05710432","Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training","Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training in Difficult and Prolonged Weaning Patients: a Physiological Study - The FLEX Study","FLEX","Inclusion Criteria:\n\n* 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\u002For prolonged ventilation) and able to spontaneously trigger the ventilator.\n* Over or equal to 16 years of age\n* Tolerating levels of pressure support of 10 cmH2O or lower (or equivalent support in NAVA or PAV+) for at least 15 minutes\n* In stable clinical and hemodynamic conditions and adequate level of oxygenation (cardiac frequency ≤ 140 beats\u002Fminute, systolic blood pressure 90-160 mmHg, no or minimal vasopressors, PaO2\u002FFiO2 over or equal to 150 mmHg)\n* Able to understand and follow simple verbal instructions\n\nExclusion Criteria:\n\n* Patients with a previously diagnosed severe neuromuscular disorder (such as amyotrophic lateral sclerosis, muscular dystrophy, multiple sclerosis, myasthenia gravis or spinal cord injury)\n* Patients with chronic respiratory failure already ventilated before ICU admission\n* Patients unable to collaborate or understand instructions","ALL","16 Years",{"count":79,"type":80},10,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nPromising 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.\n\nTherefore, 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.\n\nThe 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\u002Frecruitment during neck flexion will be comparable or even greater to that occurring during IMT, as found in healthy subjects.\n\nFinding 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.",[86,87],"Mechanical Ventilator Weaning","Respiratory Muscle Training",[89,16,90,86],"Mechanical Ventilation","Neck Flexion","2025-05-15",{"date":93,"type":94},"2025-05-20","ACTUAL",{"date":96,"type":94},"2023-02-09",{"date":98,"type":80},"2025-11-15",{"name":5,"class":6},1]