Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training — FLEX  

Respiratory Muscle Training Clinical Trial

Official title: Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training in Difficult and Prolonged Weaning Patients: a Physiological Study - The FLEX Study

Status Not yet recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mechanical Ventilator Weaning
• Respiratory Aspiration
• Respiratory Muscle Training

• NCT number: NCT05710432
• Study type: Interventional
• Source: Unity Health Toronto
• Contact: Laurent Brochard, MD, PhD
• Phone: 416-864-5686
• Email: Laurent.Brochard@unityhealth.to
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 9, 2023
• Completion date: November 15, 2023