ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Airway management

Condition category

Condition code

Anaesthesiology

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]

Treatment: Devices

Intervention code [2]

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]

Time to desaturation from Sp02 100% to 92% measured with oximetry

Timepoint [1]

Time to desaturation to 92% from end of bag mask ventilation

Secondary outcome [1]

Changes in transcutaneous oxygen saturation measure with oximetry

Timepoint [1]

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]

Changes in transcutaneous CO2 tension measure by Phillips monitor

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Lady Cilento Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Lady Cilento Children's Hospital

Address

501 Stanley Street
South Brisbane
Queensland 4101

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Paediatric Critical Care Research Group

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Service Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/09/2015

Ethics approval number [1]

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

A/Prof Andreas Schibler

Address

Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
Qld 4101

Country

Australia

Phone

+617 3068 5733

Fax

a.schibler@uq.edu.au

Contact person for public queries

Name

Andreas Schibler

Address

Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
Qld 4101

Country

Australia

Phone

+617 3068 5733

Fax

a.schibler@uq.edu.au

Contact person for scientific queries

Name

Andreas Schibler

Address

Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
Qld 4101

Country

Australia

Phone

+617 3068 5733

Fax

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

Source	Title	Year of Publication	DOI
Embase	Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: A randomized controlled trial.	2017	https://dx.doi.org/10.1093/bja/aew401

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically