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Trial registered on ANZCTR


Registration number
ACTRN12615000452594
Ethics application status
Approved
Date submitted
28/04/2015
Date registered
11/05/2015
Date last updated
22/03/2016
Type of registration
Prospectively registered

Titles & IDs
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?
Secondary ID [1] 286601 0
Nil
Universal Trial Number (UTN)
U1111-1169-6846
Trial acronym
SIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Anaesthesia 294900 0
Condition category
Condition code
Anaesthesiology 295152 295152 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 Pressure will be decreased and the laryngoscope may be withdrawn slightly to simulate a Cormack and Lehane grade 3 view.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The soft tipped catheter as well as the guidewire will now be withdrawn and completely removed, with the endotracheal tube left in situ.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.
Intervention code [1] 291723 0
Treatment: Devices
Comparator / control treatment
No control group - pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294916 0
Successful intubation
Timepoint [1] 294916 0
Within 60 seconds from second face mask removal.
Secondary outcome [1] 314330 0
Time to appearance of capnography trace.
Timepoint [1] 314330 0
Within 60 seconds from second face mask removal.
Secondary outcome [2] 314331 0
Modified intubation difficulty score
Timepoint [2] 314331 0
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.
Secondary outcome [3] 314332 0
Visual analogue scale of procedural difficulty
Timepoint [3] 314332 0
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.
Secondary outcome [4] 314333 0
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.
Timepoint [4] 314333 0
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.

Eligibility
Key inclusion criteria
Adults
Elective surgical patients requiring intubation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
31/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3734 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 9608 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 291169 0
Charities/Societies/Foundations
Name [1] 291169 0
Townsville Hospital Anaesthetic Department Education Trust Fund
Country [1] 291169 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus Smith Drive
Douglas
QLD 4814
Country
Australia
Secondary sponsor category [1] 289848 0
None
Name [1] 289848 0
Address [1] 289848 0
Country [1] 289848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292743 0
Townsville Hospital and Health Service Human Research and Ethics Committee
Ethics committee address [1] 292743 0
Ethics committee country [1] 292743 0
Australia
Date submitted for ethics approval [1] 292743 0
20/04/2015
Approval date [1] 292743 0
24/04/2015
Ethics approval number [1] 292743 0
HREC/15/QTHS/38

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56826 0
Dr Claire Furyk
Address 56826 0
Anaesthetic Department
The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 56826 0
Australia
Phone 56826 0
+617 44331111
Fax 56826 0
Email 56826 0
Claire.Furyk@health.qld.gov.au
Contact person for public queries
Name 56827 0
Claire Furyk
Address 56827 0
Anaesthetic Department
The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 56827 0
Australia
Phone 56827 0
+617 44331111
Fax 56827 0
Email 56827 0
Claire.Furyk@health.qld.gov.au
Contact person for scientific queries
Name 56828 0
Claire Furyk
Address 56828 0
Anaesthetic Department
The Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 56828 0
Australia
Phone 56828 0
+617 44331111
Fax 56828 0
Email 56828 0
Claire.Furyk@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.