Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

Ankara Diskapi Training and Research Hospital

Status: Completed

Conditions: Ventilatory Failure

Treatments: Device: tritube

Study type: Interventional

Funder types: Other

Identifiers

NCT05813977

Droplet

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups

Group 1: Tritube (FCV) used during tracheostomy

Experimental group

Description:

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.

Treatment:

Device: tritube

Group 2: Conventional endotracheal tube used during tracheostomy

No Intervention group

Description:

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.