Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

Summary

Tracheostomy is a vital procedure in the ICU to maintain the airway and prevent complications that may occur due to intubation. It helps reduce the dead space volume, airway resistance and provides comfort to the patients during the weaning from mechanical ventilation. Two methods are widely used in Percutaneous Dilatational Tracheostomy (PDT): The multiple dilation method (Ciaglia) and the Griggs method.Griggs method will be used in the study.

The Griggs Method: A 10-15 millimeter skin incision is made between the level of the second-third tracheal rings. The location of the needle is confirmed by entering the trachea with an injector filled with 2-3 mL saline from the midline and aspirating air. A J-tipped guidewire is advanced through the needle and the needle is removed. A special forceps with a channel at the tip, through which the guidewire can pass is used in this method. The forceps advanced through the guidewire and then subcutaneous tissues and trachea are dilated in one or two steps. When the stoma is large enough to insert the cannula, it is placed in the trachea and fixed.

Patients who will undergo tracheostomy in the ICU will be included in the study and randomly assigned into two groups. Two different methods, endotracheal tube (ET) or laryngeal mask (LMA), will be used during the tracheostomy for airway management. In both methods, fiberoptic bronchoscopy will assist the procedure.

Researchers aim to compare the two airway management methods in terms of complications, procedure time, and the number of staff needed.

Conditions

• Intubation, Intratracheal
• Tracheostomy
• Laryngeal Masks
• Intensive Care Units

Interventions

PROCEDURE

Endotracheal Tube Insertion

ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords)

PROCEDURE

Laryngeal Mask Insertion

After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted.

PROCEDURE

Fiberoptic Bronchoscopy

After the patients' airway is established, the trachea and the process area will be displayed by the physician. The success rate will be increased by performing the procedure with fiberoptic bronchoscopy.

PROCEDURE

Radial Artery Monitoring

The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way.

DIAGNOSTIC_TEST

Anteroposterior chest x-ray

When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray.

DIAGNOSTIC_TEST

Arterial Blood Gas Analyses

Hypoxia, acidosis and carbon dioxide increase will be followed

DRUG

Propofol Fresenius

2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started.

DRUG

Rocuronium

0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given.

DRUG

Fentanyl

1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.

Sponsors & Collaborators

• Bozyaka Training and Research Hospital

  lead OTHER

Principal Investigators

• Elif Göktaş · Izmir Bozyaka Research and Trainings Hospital

• Zeki T TEKGUL · Izmir Bozyaka Research and Trainings Hospital

• Hüseyin ÖZKARAKAŞ · Izmir Bozyaka Research and Trainings Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2021-08-01

Completion

2021-10-01