Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06776939

Effects of High-Flow Tracheal Oxygen Compared to Conventional Oxygen Therapy on Mucus Thickness and Breathing Effort in Patients Weaning from Mechanical Ventilation

Led by Henrik Endeman · Updated on 2025-01-15

20

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

Sponsors

H

Henrik Endeman

Lead Sponsor

F

Fisher and Paykel Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of high-flow tracheal oxygen (HFTO) compared to conventional oxygen therapy (COT) on airway mucus viscosity and breathing effort in adult patients who are weaning from invasive mechanical ventilation with a tracheostomy. The study aims to determine whether HFTO can reduce sputum thickness, ease breathing effort, and lessen the feeling of breathlessness during the weaning process. This pilot study uses a randomized crossover design involving twenty adult patients. Participants receive both treatments—HFTO and COT—during the weaning phase over two separate days in a randomized order. Oxygen therapy is delivered during disconnection sessions from mechanical ventilation, which may be short (less than 90 minutes) or long (up to 12 hours). Each type of disconnection session is performed twice, once with HFTO and once with COT, allowing direct comparison of the two methods. During the study, researchers measure the thickness and elasticity of sputum using rheology during the long disconnection sessions and assess respiratory effort through esophageal pressure changes. They also evaluate the severity and frequency of breathlessness using a visual analogue scale. All procedures involve standard clinical practices with minimal risk. The total duration of participation depends on the weaning timeline and the disconnection sessions scheduled for each patient.

CONDITIONS

Official Title

Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning from Invasive Mechanical Ventilation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Currently weaning from mechanical ventilation with a tracheostomy
Not Eligible

You will not qualify if you...

  • Longstanding tracheostomy present before current hospital admission
  • Tracheostomy primarily for chronic upper airway obstruction or airway patency due to persistent stupor/coma
  • Chronic positive pressure respiratory support at home (excluding night-time CPAP for sleep apnea)
  • History of mucociliary diseases such as cystic fibrosis or pulmonary ciliary dyskinesia
  • History of neuromuscular disease (excluding ICU-acquired weakness)
  • Contraindications for esophageal balloon placement including fractures in mandibular, orbital, ethmoid bone or skull base; esophageal varices or surgery; severe bleeding disorders
  • Hemoptysis in the 72 hours before the first disconnection session requiring intervention or pro-coagulating drugs like tranexamic acid

AI-Screening

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Trial Site Locations

Total: 1 location

1

Erasmus Medical Center

Rotterdam, Netherlands, 3015

Actively Recruiting

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Research Team

T

Thijs Janssen Resident pulmonology, Critical Care researcher, MD

H

Henrik Endeman Intensivist, Assistant Professor Intensive Care, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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