Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy

Tracheostomy Complication Clinical Trial

Official title:

Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy as an Alternative to a Classic Mechanical Ventilation by Endotracheal Tube

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188613
• Other study ID #: HFJV
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: January 2021
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Percutaneous tracheostomy is the mouth opening of the tracheal ostium to the skin by creating an opening in the anterior wall of the trachea using Seldinger methods. This procedure is done using an endotracheal tube (ETT) or a laryngeal mask (LMA). High-frequency jet ventilation (HFJV) commonly used in oropharyngeal surgeries and creates an extra passage for the procedure. The investigators aimed to demonstrate the effective use of HFJV in percutaneous tracheostomy.

Description:

Seventy five patients between 18-80 years of age who were hospitalized in intensive care unit were included in the study. The number of patients will be finalized by power analysis. whose written consent cannot be obtained and who undergo surgical tracheostomy for any reason will be excluded from the study. In addition, patients with active infection in the area of the procedure, bleeding diathesis and pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.) will be excluded from the study. Patients will be divided into three groups as those using classical ventilation (group 1), HFJV (group 2) and classical laryngeal mask (group 3). Age, gender, height, BMI, ASA scores, presence and type of additional diseases, tracheostomy day, pre- and post-procedure blood gas analysis, duration of procedure, duration of anesthesia, complications during the procedure (bleeding , desaturation, accidental extubation, malposition, bradycardia, hypotension, etc.) will be recorded. Patients will be observed for mortality in the first 30 days after the procedure. Mortality results will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

• bleeding diathesis

• pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.)

Related Conditions & MeSH terms

• High-frequency Jet Ventilation
• Percutaneous Tracheostomy
• Tracheostomy Complication

Intervention

Device:
• Percutaneous tracheostomy
Age, gender, height, BMI, ASA scores, presence and type of additional diseases, tracheostomy day, pre- and post-procedure blood gas analysis, duration of procedure, duration of anesthesia, complications during the procedure (bleeding , desaturation, accidental extubation, malposition, bradycardia, hypotension, etc.) will be recorded from intensive care follow-up. Patients will be observed for mortality in the first 30 days after the procedure. Mortality results will be recorded.

Locations

Country	Name	City	State
Turkey	Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital Ankara, Turkey	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percutaneous tracheostomy time	the time the needle enters the skin to the insertion of the tracheostomy cannula	during procedure
Secondary	complications rate	the complications such as ET cuff puncture, Difficult insertion of tracheostomy tube, Accidental extubation, Bleeding vs. during percutaneous tracheostomy	during procedure