Clinical Trials Logo

Clinical Trial Summary

While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, the aim of the proposed study is to examine the short-term effects of HFOT as opposed to oxygen therapy via T-piece on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation.


Clinical Trial Description

Critically ill patients who experience difficulties in weaning from the ventilator often undergo tracheostomy. These patients usually undergo spontaneous breathing trials receiving oxygen via T-piece. While the high flow oxygen therapy (HFOT) respiratory support system, delivered through nasal cannulas, has demonstrated clinical benefits on respiratory function, limited data exist on whether such effects are also present in HFOT through tracheostomy. Therefore, we plan to perform a study to examine the short-term effects of HFOT on diaphragmatic function in tracheostomized patients with prolonged weaning from mechanical ventilation. After disconnection from the ventilator, patients will undergo a 30-minute spontaneous breathing trial receiving oxygen either conventionally via T-piece, or by HFOT delivered via tracheostomy, followed by a washout period of 15 min breathing through T-piece and 30 min receiving oxygen with the other modality in a randomized manner. At the start and end of each study period, patients will undergo an assessment through diaphragm ultrasonography, which includes excursion of diaphragmatic dome and thickness of diaphragmatic zone of apposition at end-inspiration and end-expiration. Subsequently, the diaphragmatic thickening fraction will be calculated as the difference between end-inspiratory and end-expiratory thickness divided by end-expiratory thickness. Also. arterial blood gases as well as respiratory rate (RR) and tidal volume (TV) (through a Wright's spirometer) will be measured. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04758910
Study type Interventional
Source Evangelismos Hospital
Contact Christina I Routsi, MD
Phone 0030 6944508305
Email chroutsi@hotmail.com
Status Not yet recruiting
Phase N/A
Start date March 1, 2021
Completion date July 30, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05539599 - Comprehensive Ultrasound Evaluation as a Predictor of Weaning
Completed NCT02845076 - Weaning From Noninvasive Ventilation N/A
Completed NCT01915563 - Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure N/A
Recruiting NCT01721434 - Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients Phase 2/Phase 3
Completed NCT01928277 - Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing N/A
Recruiting NCT05632822 - Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation
Recruiting NCT03240263 - Inspiratory Muscle Training in Difficult to Wean Patients N/A
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A
Completed NCT01867853 - Volume Responsiveness Before SBT Predicts the Outcome of Mechanical Ventilation Weaning in Critically Ill Patients N/A
Recruiting NCT06040138 - Monitoring of Breathing Effort Through Pressure Time Product Measurement Using Airway Occlusion Pressure
Completed NCT06224010 - Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
Completed NCT03129217 - The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients
Not yet recruiting NCT05431036 - Evaluation of a Combined Model in Predicting Weaning Outcome in Critically Ill Patients.
Completed NCT05550220 - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients N/A
Recruiting NCT05906888 - Weaning With Tracheostomy - an Observational Study on Patient-centered Outcomes
Recruiting NCT05944588 - Predictive Value of Chest Ultrasound Observation on Extubation Failure
Not yet recruiting NCT05802745 - P0.1 and Extubation Failure in Critically Ill Patients
Recruiting NCT03894189 - The Effect of Doxapram Versus Theophylline on Diaphragmatic Function N/A
Completed NCT01877850 - Utility of a Weaning Protocol in ICU N/A
Completed NCT03580720 - Electromyography for Diaphragm Effort N/A