RecruitingNot ApplicableNCT05710432

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


Sponsor

Unity Health Toronto

Enrollment

10 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the neck and breathing muscles work together during inspiratory muscle training (IMT) in patients who have difficulty coming off a ventilator (breathing machine). Prolonged mechanical ventilation weakens the breathing muscles, and IMT is used to strengthen them. This study uses ultrasound and other monitoring tools to see which muscles are being recruited during neck flexion and breathing exercises, helping optimize rehabilitation techniques. You may be eligible if: - You are 16 years or older - You are on mechanical ventilation (through a breathing tube or tracheostomy) due to difficulty weaning from the ventilator - You are able to trigger the ventilator spontaneously - Your condition is hemodynamically stable with adequate oxygen levels - You are able to follow simple verbal instructions You may NOT be eligible if: - You have a diagnosed severe neuromuscular disorder (e.g., ALS, muscular dystrophy, multiple sclerosis, myasthenia gravis, or spinal cord injury) - You had chronic respiratory failure and were on a ventilator before your ICU admission - You are unable to follow instructions or collaborate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERQuasi-Isometric Neck Flexion

Patients will be asked to minimally lift their head from the pillow generating a quasi-isometric neck contraction (2 sets of 6-10 flexions).

OTHERInspiratory Muscle Training

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.


Locations(1)

St. Michael's Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05710432


Related Trials