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Search / Trial NCT04941456

Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?

Launched by GAYLORD HOSPITAL, INC · Jun 24, 2021

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Tracheostomy Pmv Passy Muir Valve Activity Tolerance Intra Thoracic Pressure Six Minute Walk Test Borg Rating Of Perceived Exertion Oxygen Saturation

ClinConnect Summary

A Passy-Muir Valve (PMV) is a one-way valve that blocks air flow from exhalation in patients with a tracheostomy, and redirects it through to the upper airway to enable functional use of the glottis.

Typically, PMVs are used to assist patients being weaned from mechanical ventilation to communicate more effectively after tracheostomy. Devices are available that can be used in-line with the ventilator, as well as after ventilator liberation with a tracheostomy collar. PMVs provide patients with the ability to communicate, swallow, and improve diaphragmatic strength, which lengthens the peri...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Individual with tracheostomy who can tolerate daily 30 minute Physical Therapy sessions with use of PMV and be able to maintain oxygen saturations above 88% with exertion.
  • 2. Ability to understand and respond to simple verbal instructions and one step commands in English well enough to consent without any interpretation.
  • 3. Ability to ambulate a minimum of 10 feet with/without assistive device and with/without physical assistance.
  • Exclusion Criteria:
  • 1. Active seizures
  • 2. Active Pregnancy
  • 3. Uncontrolled hypertension
  • 4. Cognitive deficits that would disrupt ability to provide informed consent
  • 5. Enteric infection control precautions
  • 6. Ongoing orthostasis
  • 7. Actively on decannulation protocol
  • 8. Medical instability that would cause a doctor to put therapy program on hold

About Gaylord Hospital, Inc

Gaylord Hospital, Inc. is a leading healthcare institution dedicated to providing specialized rehabilitation services and innovative clinical trials aimed at improving patient outcomes. With a commitment to excellence in patient care and research, Gaylord Hospital leverages its state-of-the-art facilities and multidisciplinary expertise to explore new therapeutic interventions and enhance the quality of life for individuals with complex medical conditions. The organization fosters a collaborative environment that prioritizes safety, ethical standards, and patient-centered approaches in all clinical research initiatives.

Locations

Wallingford, Connecticut, United States

Patients applied

0 patients applied

Trial Officials

Erica Cutler, DPT

Principal Investigator

Gaylord Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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