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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?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000452594
Acronym
SIS
Enrollment
30
Registered
2015-05-11
Start date
2015-08-31
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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 Pressure will be decreased and the laryngoscope may be withdrawn slightly to simulate a Cormack and Lehane grade 3 view.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.

Sponsors

The Townsville Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026