Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Currently weaning from mechanical ventilation with a tracheostomy
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
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Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, Netherlands, 3015
Actively Recruiting
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
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