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Search / Trial NCT05710432

Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training

Launched by UNITY HEALTH TORONTO · Jan 23, 2023

Trial Information

Current as of August 02, 2025

Recruiting

Keywords

Mechanical Ventilation Inspiratory Muscle Training Neck Flexion Mechanical Ventilator Weaning

ClinConnect Summary

This clinical trial is studying a new way to help patients who are having difficulty getting off mechanical ventilation, which is a machine that helps them breathe. The researchers want to see if a technique called neck flexion, which involves simple neck movements, is better tolerated and safer than traditional inspiratory muscle training (IMT) exercises. They believe that neck flexion can help activate important muscles used for breathing, similar to IMT, without needing to disconnect patients from the ventilator. This could make it easier for patients to strengthen their breathing muscles and improve their overall recovery.

To participate in the trial, patients must be at least 16 years old and receiving mechanical ventilation through a tube, having struggled to breathe on their own after trying several weaning attempts. They should be stable and able to follow basic instructions. The trial aims to see how well patients can do neck flexion compared to IMT, and to understand which muscles are being used during these exercises. If you or a loved one meet the criteria and are interested in participating, this trial could offer a promising new approach to improving recovery from mechanical ventilation.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

About Unity Health Toronto

Unity Health Toronto is a leading healthcare organization dedicated to providing exceptional patient care, advancing medical research, and fostering education in the field of health sciences. Comprising St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare, Unity Health integrates a diverse range of clinical services and innovative research initiatives. The organization is committed to improving health outcomes through collaborative partnerships and community engagement, while upholding the highest standards of ethics and integrity in its clinical trials and research endeavors. By focusing on patient-centered approaches, Unity Health Toronto aims to drive advancements in healthcare and contribute to the well-being of the communities it serves.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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