Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

Ventilatory Failure Clinical Trial

Official title:

Is it Possible to Decrease Droplet Generation During Percutaneous Dilatational Tracheotomy?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813977
• Other study ID #: Droplet
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 15, 2023

Study information

• Verified date: April 2023
• Source: Ankara Diskapi Training and Research Hospital
• Contact: Eda MACIT AYDIN
• Phone: 5322665232
• Email: edamct[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 15, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Ventilatory Failure

Intervention

Device:
• tritube
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.

Locations

Country	Name	City	State
Turkey	Diskapi Training and Resource Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the outcome measures (droplet account) are assessing a change	The investigators hypothesized that droplet account will decrease while tritube using	1th min before sterilization and 1th min after tracheostomy cannula insertion
Secondary	complication rates	the complications such as endotracheal tube (ET) cuff puncture, Difficult insertion of tracheostomy tube, Accidental extubation, Bleeding vs. during percutaneous tracheostomy	24 hour after tracheostomy procedure