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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000452594
• Date of registration: 11/05/2015
• Prospective Registration: Yes
• Primary sponsor: The Townsville Hospital
• Public title: 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
• Scientific title: In elective surgical patients, is intubation using a Cook Staged Extubation Set for endotracheal tube insertion in simulated difficult airway feasible?
• Date of first enrolment: 31/08/2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000452594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Claire Furyk

• Name: Dr Claire Furyk

Key inclusion & exclusion criteria

Inclusion criteria: Adults
Elective surgical patients requiring intubation
Exclusion criteria: 1. American Society of Anaesthesiologists (“ASA”) physical status classification >2
2. Body Mass Index (“BMI”) >35
3. Previously recorded Cormack and Lehane (“C&L”) classification > grade 2 laryngeal view
4. Previously recorded need to use an accessory device to accomplish tracheal intubation, eg. Frova Airway Intubating Catheter or Gum Elastic Bougie
5. Any disease or condition that may significantly reduce the time between the onset of apnoea and arterial haemoglobin oxygen desaturation
6. Any condition or morphological feature that may compromise face mask ventilation
7. Planned rapid sequence intubation


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

General Anaesthesia;
General Anaesthesia

Anaesthesiology - Anaesthetics

Intervention(s)

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.

Primary Outcome(s)

Successful intubation[Within 60 seconds from second face mask removal.]

Secondary Outcome(s)

Visual analogue scale of procedural difficulty[Completed by intubator after intubation is completed, tube is secured, and they are free from other immediate practical tasks related to the case. Likely to be within 10 minutes of completing the intubation procedure.]

Modified intubation difficulty score[Completed by intubator after intubation is completed, tube is secured, and they are free from other immediate practical tasks related to the case. Likely to be within 10 minutes of completing the intubation procedure.]

Other comments. In addition to the structured assessment of the device in outcomes 2 and 3, the intubator will be asked whether they would like to offer any additional remarks about the use of the device.[After intubation is completed, tube is secured, and the intubator is free from other immediate practical tasks related to the case. Likely to be within 10 minutes of completing the intubation procedure.]

Time to appearance of capnography trace.[Within 60 seconds from second face mask removal.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Townsville Hospital Anaesthetic Department Education Trust Fund

Ethics review

Status: Approved
Approval date:
Contact:

Townsville Hospital and Health Service Human Research and Ethics Committee