Clinical trial NCT05813977: Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy
Official title: Is it Possible to Decrease Droplet Generation During Percutaneous Dilatational Tracheotomy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilatory Failure
Keywords: Percutaneous Dilatational Tracheotomy
Flow controlled ventilation
droplet
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Tritube (FCV) Group 2: Conventional endotracheal tube
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* percutaneous tracheostomy procedure

Exclusion Criteria:

* whose written consent cannot be obtained
* who undergo surgical tracheostomy for any reason
* patients with active infection in the area of the procedure

Primary outcomes:
measure: the outcome measures (droplet account) are assessing a change
timeFrame: 1th min before sterilization and 1th min after tracheostomy cannula insertion
Secondary outcomes:
measure: complication rates
timeFrame: 24 hour after tracheostomy procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Resource Hospital
Study officials:
affiliation: Ankara Diskapi Training and Research Hospital
name: Eda MACİT AYDIN
role: PRINCIPAL_INVESTIGATOR
References: