Use of High-Frequency Jet Ventilation During Percutaneous Tracheostomy

NCT ID: NCT04188613

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-04-01

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.

Conditions

Tracheostomy Complication; High-frequency Jet Ventilation; Percutaneous Tracheostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

HFJV

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.

Group Type: EXPERIMENTAL

Percutaneous tracheostomy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Percutaneous tracheostomy

Intervention Type: 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.

LMA

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous tracheostomy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Savas Altinsoy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HFJV

Identifier Type: -

Identifier Source: org_study_id