An interventional study of tritube in Ventilatory Failure, sponsored by Ankara Diskapi Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Ankara Diskapi Training and Research Hospital · Not applicable, Interventional, and Prevention
During the percutaneous dilatational tracheostomy (PDT), large amount of droplets and aerosols are spread to the environment especially with the effect of ventilation during the dilatation phase. In such cases, it is recommended to take precautions such as masks and goggles or shields to protect practitioners from infection, however it has also been reported that droplets and aerosols can spread to the environment and can go far.
Flow controlled ventilation (FCV) with the use of Tritube® and Evone® could reduce droplet spread during PDT and provide a safer environment while operating on patients with infected airways.
During the percutaneous dilatational tracheostomy, large amount of droplets and aerosols are spread to the environment especially with the effect of ventilation during the dilatation phase. In such cases, it is recommended to take precautions such as masks and goggles or shields to protect practitioners from infection, however it has also been reported that droplets and aerosols can spread to the environment and can go far.
Flow controlled ventilation (FCV) with the use of Tritube® and Evone® could reduce droplet spread during PDT and provide a safer environment while operating on patients with infected airways.
SPSS 21.0 (Statistical Package for the Social Sciences) (Version 22.0, SPSS, Inc, Chicago, USA) program will be used for statistical analysis. After applying the Shapiro-wilk test for normality, the student's t test will be used if the distribution is not normal. Fisher's exact test or chi-square test will be used for categorical variables. Results p\<0.05 will be considered significant.
The investigators compared the amount of droplets scattered in the environment with PDT performed with FCV and conventional mechanical ventilation methods, with the ATP (adenosine triphosphate) bioluminescence method.
96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.
This study's enrollment of 39 is below the median of 52 across 63 interventional studies indexed under Hypoventilation.
Browse Hypoventilation studies →Ankara Diskapi Training and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The patient is intubated with Tritube® after the removal of the conventional endotracheal tube (ETT) and Tritube® was advanced until proximal to the carina. Before starting the PDT, measurements with ATP bioluminescence-based method (3M Clean-trace®) were made by taking sample from a sterile PVC (poly vinyl chloride) surface (10 cm2) which is held 50 cm over the operation site. After PDT with Griggs method (Portex), the measurements were repeated by taking sample from surface.
Device: tritube
In the patient who was intubated with a conventional endotracheal tube (ETT), the tube was withdrawal to the vocal cords. Before starting the PDT, measurements with ATP bioluminescence-based method (3M Clean-trace®) were made by taking sample from a sterile PVC surface (10 cm2) which is held 50 cm over the operation site. After PDT with Griggs method (Portex), the measurements were repeated by taking sample from surface.
The patient is intubated with Tritube® after the removal of the conventional endotracheal tube (ETT) and Tritube® was advanced until proximal to the carina. Before starting the PDT, measurements with ATP bioluminescence-based method (3M Clean-trace®) were made by taking sample from a sterile PVC surface (10 cm2) which is held 50 cm over the operation site. After PDT with Griggs method (Portex), the measurements were repeated by taking sample from surface.
the outcome measures (droplet account) are assessing a change
The investigators hypothesized that droplet account will decrease while tritube using
Time frame: 1th min before sterilization and 1th min after tracheostomy cannula insertion
complication rates
the complications such as endotracheal tube (ET) cuff puncture, Difficult insertion of tracheostomy tube, Accidental extubation, Bleeding vs. during percutaneous tracheostomy
Time frame: 24 hour after tracheostomy procedure
Ran from Apr 2023 to primary completion in Sep 2023, 5 months.
Of 35 non-industry interventional studies with no phase under Hypoventilation, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 5 months is below that.
Counting every sponsor, half of 35 studies reached it within 15 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Ankara Diskapi Training and Research Hospital