Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

Sponsor
Ankara Diskapi Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05813977
Collaborator
(none)
30
1
2
1.5
20.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: tritube
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group 1: Tritube (FCV) Group 2: Conventional endotracheal tubeGroup 1: Tritube (FCV) Group 2: Conventional endotracheal tube
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Is it Possible to Decrease Droplet Generation During Percutaneous Dilatational Tracheotomy?
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: Tritube (FCV) used during tracheostomy

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
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.

No Intervention: Group 2: Conventional endotracheal tube used during tracheostomy

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.

Outcome Measures

Primary Outcome Measures

  1. the outcome measures (droplet account) are assessing a change [1th min before sterilization and 1th min after tracheostomy cannula insertion]

    The investigators hypothesized that droplet account will decrease while tritube using

Secondary Outcome Measures

  1. complication rates [24 hour after tracheostomy procedure]

    the complications such as endotracheal tube (ET) cuff puncture, Difficult insertion of tracheostomy tube, Accidental extubation, Bleeding vs. during percutaneous tracheostomy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diskapi Training and Resource Hospital Ankara Turkey 06010

Sponsors and Collaborators

  • Ankara Diskapi Training and Research Hospital

Investigators

  • Principal Investigator: Eda MACİT AYDIN, Ankara Diskapi Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eda Macit Aydın, Principal Investigator, specialist, intensivisit, Ankara Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05813977
Other Study ID Numbers:
  • Droplet
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eda Macit Aydın, Principal Investigator, specialist, intensivisit, Ankara Diskapi Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023