Amount of Droplet Formed During Percutaneous Dilatational Tracheostomy

NCT05813977 | Completed

• 1 other identifier: Droplet
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilatory Failure

Keywords

Percutaneous Dilatational Tracheotomy; Flow controlled ventilation; droplet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• complication rates

  24 hour after tracheostomy procedure

Study Arms (2)

Group 1: Tritube (FCV) used during tracheostomy

EXPERIMENTAL

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

Group 2: Conventional endotracheal tube used during tracheostomy

NO INTERVENTION

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.

Interventions

tritube DEVICE

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.

Group 1: Tritube (FCV) used during tracheostomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• percutaneous tracheostomy procedure

You may not qualify if:

• whose written consent cannot be obtained
• who undergo surgical tracheostomy for any reason
• patients with active infection in the area of the procedure

Sponsors & Collaborators

• Ankara Diskapi Training and Research Hospital: lead

Study Sites (1)

Diskapi Training and Resource Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eda MACİT AYDIN

  Ankara Diskapi Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, specialist, intensivisit

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

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 14, 2023
• Study Start: April 11, 2023
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

TU (1)