RecruitingACTRN12615000452594

A pilot study assessing the Cook Staged Extubation Set for endotracheal tube insertion in simulated difficult airway in patients undergoing routine intubation for elective surgery

In elective surgical patients, is intubation using a Cook Staged Extubation Set for endotracheal tube insertion in simulated difficult airway feasible?


Sponsor

The Townsville Hospital

Enrollment

30 participants

Start Date

Aug 31, 2015

Study Type

Interventional

Conditions

Summary

This is a pilot study assessing the useability of a kit designed to assist re-intubation in patients with a difficult airway. 30 patients presenting for elective surgery will be intubated using the Cook Staged Extubation Set. A difficult airway will be simulated by releasing pressure on the laryngoscope to obtain a grade 3 view. The procedure will be timed and evaluated for difficulty by the intubator.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether a special kit (the Cook Staged Extubation Set) can help with re-insertion of a breathing tube in patients who have a difficult airway. Thirty patients undergoing routine elective surgery requiring general anaesthesia will be enrolled, and a difficult airway will be safely simulated during the procedure. You may be eligible if: - You are 18 years of age or older - You are scheduled for elective surgery that requires a breathing tube (intubation) You may NOT be eligible if: - You have significant other medical conditions (ASA physical status greater than 2) - Your body mass index (BMI) is above 35 - You have previously had a very difficult intubation (Cormack-Lehane grade above 2) - You have previously needed special tools to be intubated - You have a condition that causes your oxygen to drop quickly when you stop breathing - You have a condition that makes using a face mask to breathe difficult - You are planned for a rapid sequence intubation Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In place of immediately introducing an ETT into the trachea, the guidewire from the Cook Staged Extubation Kit will, under direct laryngoscopy, be inserted into the trachea. The guidewire will be left

In place of immediately introducing an ETT into the trachea, the guidewire from the Cook Staged Extubation Kit will, under direct laryngoscopy, be inserted into the trachea. The guidewire will be left in the trachea, the laryngoscope removed and the external part of the guidewire kept to the right side of the patient’s head. The purpose of the intervention up to this point is to have the patient with a guidewire in place, in order to simulate a staged extubation. The procedure up to this stage is estimated to take 30 seconds. Face mask ventilation will be resumed for a few breaths to ensure adequate anaesthesia and oxygenation. The face mask will be removed and laryngoscopy performed. Pressure will be decreased and the laryngoscope may be withdrawn slightly to simulate a Cormack and Lehane grade 3 view. The Cook staged extubation kit will be used in the prescribed way for reintubation from this point onwards. This requires the soft tipped catheter to be introduced into the trachea over the guidewire, followed by the endotracheal tube introduced into the trachea over the soft tipped catheter. Introduction of the catheter and endotracheal tube will be achieved without direct vision of the vocal cords, as the laryngoscope will be manipulated in such a way as to maintain a C&L grade 3 view. The soft tipped catheter as well as the guidewire will now be withdrawn and completely removed, with the endotracheal tube left in situ. The intubation will be timed from second face mask removal and is expected to take less than 60 seconds.


Locations(1)

The Townsville Hospital - Douglas

QLD, Australia

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