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Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

Primary Purpose

Ventilatory Failure

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
tritube
Sponsored by
Ankara Diskapi Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilatory Failure focused on measuring Percutaneous Dilatational Tracheotomy, Flow controlled ventilation, droplet

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diskapi Training and Resource HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1: Tritube (FCV) used during tracheostomy

Group 2: Conventional endotracheal tube used during tracheostomy

Arm 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.

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.

Outcomes

Primary Outcome Measures

the outcome measures (droplet account) are assessing a change
The investigators hypothesized that droplet account will decrease while tritube using

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2023
Last Updated
April 3, 2023
Sponsor
Ankara Diskapi Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05813977
Brief Title
Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy
Official Title
Is it Possible to Decrease Droplet Generation During Percutaneous Dilatational Tracheotomy?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Diskapi Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Failure
Keywords
Percutaneous Dilatational Tracheotomy, Flow controlled ventilation, droplet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Tritube (FCV) Group 2: Conventional endotracheal tube
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Tritube (FCV) used during tracheostomy
Arm Type
Experimental
Arm 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.
Arm Title
Group 2: Conventional endotracheal tube used during tracheostomy
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
tritube
Intervention 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 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.
Primary Outcome Measure Information:
Title
the outcome measures (droplet account) are assessing a change
Description
The investigators hypothesized that droplet account will decrease while tritube using
Time Frame
1th min before sterilization and 1th min after tracheostomy cannula insertion
Secondary Outcome Measure Information:
Title
complication rates
Description
the complications such as endotracheal tube (ET) cuff puncture, Difficult insertion of tracheostomy tube, Accidental extubation, Bleeding vs. during percutaneous tracheostomy
Time Frame
24 hour after tracheostomy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eda MACİT AYDIN
Phone
5322665232
Email
edamct@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda MACİT AYDIN
Organizational Affiliation
Ankara Diskapi Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Training and Resource Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda MACİT AYDIN

12. IPD Sharing Statement

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Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

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