Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy

Not Applicable

Completed

• Conditions: High-frequency Jet Ventilation; Percutaneous Tracheostomy; Tracheostomy Complication
• Interventions: Device: Percutaneous tracheostomy

• Registration Number: NCT04188613
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETT	Percutaneous tracheostomy	In preparation for the percutaneous tracheotomy, the patient was covered in a sterile fashion. Endotracheal tube (ETT) was removed through the vocal cords.
HFJV	Percutaneous tracheostomy	In preparation for the percutaneous tracheotomy, the patient was covered in a sterile fashion. The patient was extubated, and the jet ventilator catheter was inserted to trachea and ventilation will be start.
LMA	Percutaneous tracheostomy	In preparation for the percutaneous tracheotomy, the patient was covered in a sterile fashion. Endotracheal tube (ETT) was removed and laryngeal mask airway device inserted.

Primary Outcome Measures

Name	Time	Method
percutaneous tracheostomy time	during procedure	the time the needle enters the skin to the insertion of the tracheostomy cannula

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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