Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy

NCT04188613 | Completed

• 1 other identifier: HFJV
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Complication; High-frequency Jet Ventilation; Percutaneous Tracheostomy

Outcome Measures

Primary Outcomes (1)

• percutaneous tracheostomy time

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

  during procedure

Secondary Outcomes (1)

• complications rate

  during procedure

Study Arms (3)

HFJV

EXPERIMENTAL

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.

Device: Percutaneous tracheostomy

ETT

ACTIVE COMPARATOR

In preparation for the percutaneous tracheotomy, the patient was covered in a sterile fashion. Endotracheal tube (ETT) was removed through the vocal cords.

Device: Percutaneous tracheostomy

LMA

ACTIVE COMPARATOR

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.

Device: Percutaneous tracheostomy

Interventions

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.

ETT; HFJV; LMA

Eligibility Criteria

• Age: 18 Years - 80 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,
• bleeding diathesis
• pathologies that interfere with the procedure in the ultrasonographic evaluation (thyroid diseases, etc.)

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: December 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

TU (1)