drugset / Trial / NCT04872881

Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

NCT04872881

Phase 4 Unknown 52 enrolled Bozyaka Training and Research Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-05-01
Primary completion
2021-08-01
Completion
2021-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous
Comparator Propofol Small molecule 6 mg/kg Intravenous
Comparator Rocuronium Other / unclassified 0.6 mg/kg Intravenous

Indications