Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06816706

Comparison of Physiological Effects of Two Types of High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials in Mechanically Ventilated Patients

Led by Jian-Xin Zhou · Updated on 2025-03-21

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating different methods of high-flow tracheal oxygen delivery during spontaneous breathing trials (SBT) in mechanically ventilated patients. The study aims to compare the physiological effects of standard and modified high-flow tracheal oxygen tubes against the traditional T-piece method. This research focuses on improving the assessment of extubation tolerance by testing a modified oxygen tube designed to increase airway pressure and resistance, potentially enhancing lung function during SBT. The trial involves five interventions: modified high-flow tracheal oxygen at flow rates of 40 and 60 liters per minute, standard high-flow tracheal oxygen at the same flow rates, and the T-piece method. Each method will be applied to patients undergoing spontaneous breathing trials to assess differences in physiological responses. The modified tube has a smaller expiratory end diameter to increase expiratory resistance and airway pressure, aiming to simulate the effects of high-flow nasal oxygen more closely. Participants will be monitored from enrollment through a 4-hour treatment period during each intervention. Key assessments include measuring mean expiratory airway pressure, positive end-expiratory pressure, and changes in end-expiratory lung volume. Secondary measures such as respiratory rate, tidal volume, oxygen saturation, and various respiratory muscle pressures will also be recorded. This data will help evaluate the impact of each oxygen delivery method on respiratory workload and lung function during weaning from mechanical ventilation.

CONDITIONS

Brief Title

Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mechanical ventilation for more than 24 hours
  • Considered ready for spontaneous breathing trials by physicians
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Age younger than 18 years old
  • Pregnancy
  • Hemodynamic instability (mean arterial pressure below 60 mmHg, heart rate above 140 or below 60 bpm)
  • Respiratory or oxygenation instability (respiratory rate above 35 breaths per minute or oxygen saturation below 90%)
  • Neuromuscular diseases or phrenic nerve injury
  • Recent trauma or surgery to the trachea, esophagus, neck, chest, or stomach
  • Pneumothorax or presence of chest drainage
  • Contraindication to electrical impedance tomography (such as having an implantable defibrillator)
  • Anticipating withdrawal of life support

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Up to 4 hours

Participants undergo spontaneous breathing trials using modified and standard high-flow tracheal oxygen at different flow rates and T-piece. Key physiological parameters will be measured during the intervention.

1 treatment visit (in-person)

Trial Site Locations

Total: 1 location

1

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China, 100038

Actively Recruiting

Loading map...

Research Team

J

Jian-Xin Zhou, MD, PhD

S

Shan-Shan Xu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

5

Similar Trials

A Pragmatic Pilot Trial Evaluating Inspiratory Pressure Adju...

Critical Care

Actively Recruiting

1 location

The PEARL Trial: Randomized Study of Warm Lactated Ringer's ...

Neonatal Respiratory Distress Related Conditions

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Physiological effects of high-flow oxygen via endotracheal tube versus T-piece strategies during spontaneous breathing trials: a study protocol and statistical analysis for a single-centre randomised crossover study.

Shan-Shan Xu, Rui-Zhi Zhang, Xu An...

https://pubmed.ncbi.nlm.nih.gov/40962338