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Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813977
Enrollment
39
Registered
2023-04-14
Start date
2023-04-11
Completion date
2023-09-14
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilatory Failure

Keywords

Percutaneous Dilatational Tracheotomy, Flow controlled ventilation, droplet

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.

Interventions

DEVICEtritube

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.

Sponsors

Ankara Diskapi Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Group 1: Tritube (FCV) Group 2: Conventional endotracheal tube

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the outcome measures (droplet account) are assessing a change1th min before sterilization and 1th min after tracheostomy cannula insertionThe investigators hypothesized that droplet account will decrease while tritube using

Secondary

MeasureTime frameDescription
complication rates24 hour after tracheostomy procedurethe complications such as endotracheal tube (ET) cuff puncture, Difficult insertion of tracheostomy tube, Accidental extubation, Bleeding vs. during percutaneous tracheostomy

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026