Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001319561
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
2/12/2015
Date last updated
23/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Apnoeic Oxygenation Time post Induction of Anaesthesia in Children comparing High Flow Nasal Cannula Oxygen Delivery with Standard Bag and Mask Technique
Scientific title
Apnoeic Oxygenation Time post Induction of Anaesthesia in Children comparing High Flow Nasal Cannula Oxygen Delivery with Standard Bag and Mask Technique
Secondary ID [1] 287520 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway management 296283 0
Condition category
Condition code
Anaesthesiology 296559 296559 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High Flow Nasal Cannula therapy (at 2mls/kg/min for children 0-15kg, 35L/min for children 15-30kg, 40L/min for 30-50kg, 50L/min for children greater than 50kg in 100%Fi02) used for a maximum 7 min and 9 sec dependant on age (see graph below) after inhalation induction of anaesthesia and bag/mask ventilation for two minutes with 100% Fi02 with flow rate adequate to provide good minute volume ventilation (normally 6L) to maintain SpO2 100% aiming for expired oxygen greater than 90% and End Tidal Carbon Dioxide 35-45mmHg; and prior to intubation in children with normal airways.

Referenced apnoeic times maximal apnoeic time for HFNC
Age 1 0-6 mths 96.5 secs 193 secs (3 min 13 secs)
2 6-24 mths 118.5 secs 237 secs (3 min 57 secs)
3 2 – 5 yrs 160.4 secs 321 secs (5 min 21 secs)
4 6 – 10 yrs 214.9 secs 429 secs (7 min 9 secs)

* Order of events:
1. Induction of anaestheisa,
2. Bag mask ventilation for 2 minutes,
3. Bag mask ventilation discontinued,
4. High flow for a maximun of 7 min and 9 sec in 100% Fi02 .
5. Bag mask ventilation recommenced. irrespectively of whether the Sp02 have changed or not.
6. Laryngoscopy is carried out to ascertain Cormack and Lehane classification and airway is secured as appropriate for procedure.
Intervention code [1] 292910 0
Treatment: Devices
Intervention code [2] 292911 0
Treatment: Other
Comparator / control treatment
After inhalation of induction of anaesthesia oxygen will be discontinued as per normal practice prior to intubation in children with normal airways.
Control group
Active

Outcomes
Primary outcome [1] 296175 0
Time to desaturation from Sp02 100% to 92% measured with oximetry
Timepoint [1] 296175 0
Time to desaturation to 92% from end of bag mask ventilation
Secondary outcome [1] 317697 0
Changes in transcutaneous oxygen saturation measure with oximetry
Timepoint [1] 317697 0
During apnoea time (Apnoea time in the control group and HFNC is defined as the time from discontinuation of assisted ventilation at End tidal O2 90% until fall in SpO2 to 92% and will be recorded in seconds and then bag and mask ventilation recommenced)
Secondary outcome [2] 318231 0
Changes in transcutaneous CO2 tension measure by Phillips monitor
Timepoint [2] 318231 0
During apnoea time (Apnoea time in the control group and HFNC is defined as the time from discontinuation of assisted ventilation at End tidal O2 90% until fall in SpO2 to 92% and will be recorded in seconds and then bag and mask ventilation recommenced)

Eligibility
Key inclusion criteria
ASA 1 or 2
Non obese
Normal airway assessment
Children presenting for elective medical imaging or surgical procedures
Suitable for inhalation induction
Minimum age
0 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obesity
Abnormal airway assessment
Oxygen dependency
Lung disease
Congenital Heart Disease
Gastro Oesophageal Reflux
Children requiring premedication of anxiolytics or sedatives
Propofol allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children presenting for elective surgery or medical imaging requiring general anaesthesia and endotracheal intubation will be screened.
Subjects that meet inclusion and exclusion criteria will be randomised by sealed envelope allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects that meet inclusion and exclusion criteria will be randomly assigned 1:1 ratio to either high flow nasal cannula therapy or standard care. Simple randomisation using a randomisation table created by computer software will be used (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
No formal sample size calculation was performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
2/02/2016
Date of last participant enrolment
Anticipated
1/02/2017
Actual
26/07/2016
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4378 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 10599 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292091 0
Self funded/Unfunded
Name [1] 292091 0
Country [1] 292091 0
Primary sponsor type
Hospital
Name
Lady Cilento Children's Hospital
Address
501 Stanley Street
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 290769 0
Other
Name [1] 290769 0
Paediatric Critical Care Research Group
Address [1] 290769 0
Paediatric Critical Care Research Group
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country [1] 290769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293575 0
Children's Health Service Human Research Ethics Committee
Ethics committee address [1] 293575 0
Children’s Health Queensland Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 293575 0
Australia
Date submitted for ethics approval [1] 293575 0
Approval date [1] 293575 0
01/09/2015
Ethics approval number [1] 293575 0
HREC/15/QRCH/158

Summary
Brief summary
Induction of anaesthesia and management of the airway is designed to prevent a child from suffering a lack of oxygen during the phase from consciousness to deep anaesthesia for a surgical procedure. Current practice provides a very high standard of induction of anaesthesia with a very low number of complications. However if anaesthesia needs to be achieved in emergency settings of in the presence of a complicated airway, the rate of complication rapidly increases. Particularly in emergency settings experienced operators are often not present. In these circumstances newer methods to reduce the risk of complications is desirable. This study investigates under very controlled circumstances in a tertiary children’s hospital a new concept to prolong the time to secure and improve airway management. The results and findings will then be tested in emergency settings in a follow up study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60526 0
A/Prof Andreas Schibler
Address 60526 0
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
Qld 4101
Country 60526 0
Australia
Phone 60526 0
+617 3068 5733
Fax 60526 0
Email 60526 0
a.schibler@uq.edu.au
Contact person for public queries
Name 60527 0
Andreas Schibler
Address 60527 0
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
Qld 4101
Country 60527 0
Australia
Phone 60527 0
+617 3068 5733
Fax 60527 0
Email 60527 0
a.schibler@uq.edu.au
Contact person for scientific queries
Name 60528 0
Andreas Schibler
Address 60528 0
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
Qld 4101
Country 60528 0
Australia
Phone 60528 0
+617 3068 5733
Fax 60528 0
Email 60528 0
a.schibler@uq.edu.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
SourceTitleYear of PublicationDOI
EmbaseTransnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: A randomized controlled trial.2017https://dx.doi.org/10.1093/bja/aew401
N.B. These documents automatically identified may not have been verified by the study sponsor.