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Search / Trial NCT07107243

SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients

Launched by CAPITAL MEDICAL UNIVERSITY · Jul 30, 2025

Trial Information

Current as of September 08, 2025

Not yet recruiting

Keywords

Transtracheal End Expiratory Pressure Speaking Valve Upper Airway Prolonged Tracheostomized Patients

ClinConnect Summary

This clinical trial is studying a new, simple way to check if the upper part of the airway (the throat and voice box area) is open and working well in patients who have had a tracheostomy—a breathing tube placed through the neck—for a long time. The researchers plan to use a special speaking valve along with a gentle pressure measurement to see if this test can predict how well the airway is functioning without needing more invasive procedures.

People who might join this study are adults who have been off a ventilator (a breathing machine) for more than two days, have stable heart and lung health, no serious infections or organ problems, and whose carbon dioxide levels in the blood are within a safe range. Patients and their families will need to agree to participate by signing a consent form. If you join, you can expect non-invasive testing that involves using the speaking valve and pressure measurements to help doctors understand your airway condition better. This study is not yet recruiting participants, but it aims to make airway checks easier and safer for people with long-term tracheostomies.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Weaned from ventilator more than 48 hours
  • No any organ failure
  • No sepsis
  • Stable heart rate and blood pressure
  • Lung infection under control
  • PCO2\<60mmHg
  • Patient and family sign informed consent form
  • Exclusion Criteria:
  • Serious dysfunction of vital organs
  • Inability to tolerate cuff deflation
  • Laryngopharyngeal trauma
  • Known severe upper airway obstruction before referrer to our department
  • Endoscopy(bronchoscopy or laryngoscopy) has been performed and the condition of the upper airway has known

About Capital Medical University

Capital Medical University is a leading institution in medical education and research, dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on scientific rigor and ethical standards, the university collaborates with a network of healthcare professionals and researchers to drive breakthroughs in medical science. Capital Medical University aims to enhance patient care and improve health outcomes by fostering a multidisciplinary approach to clinical research, ensuring that its trials are designed to address critical health challenges and contribute valuable insights to the medical community.

Locations

Patients applied

0 patients applied

Trial Officials

Hongying Jiang, MD

Study Chair

Beijing Rehabilitation Hospital of Capital Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported