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Completed

NCT Number: NCT04188613

Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Percutaneous tracheostomy

Device

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.

Primary outcomes

  1. percutaneous tracheostomy time

    Time frame: during procedure

    the time the needle enters the skin to the insertion of the tracheostomy cannula

Secondary outcomes

  1. complications rate

    Time frame: during procedure

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

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2019
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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