Trial registered on ANZCTR


Trial ID
ACTRN12617000147381
Ethics application status
Approved
Date submitted
16/12/2016
Date registered
27/01/2017
Date last updated
27/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Trans-nasal Humidified Rapid- Insufflation Ventilatory Exchange in Children Requiring Emergent Intubation (Kids THRIVE): A Randomised Controlled Trial.
Scientific title
Trans-nasal Humidified Rapid- Insufflation Ventilatory Exchange in Children Requiring Emergent Intubation (Kids THRIVE): A Randomised Controlled Trial.
Secondary ID [1] 290760 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
KIDS THRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway Management 301350 0
Condition category
Condition code
Respiratory 301108 301108 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) used during induction of anaesthesia and prior to intubation in children during emergency intubations. THRIVE allows continued oxygen delivery via high flow nasal cannual during intubation attempt; from the time the face mask is removed to successful intubation. Whereas after the traditional pre-oxygenation technique once the face mask is removed for intubation the oxygen reservoir is no longer renewed. The rate of oxygen delivered will be dependant of weight with an FiO2 of 1.0 using Optiflo registered trademark device. These will be set up only to deliver an Fi02 of 1.0.

HFNC Flow rates Comments
0-12 kg 2L/kg/min (Max 25 L/min)
13-15kg 30L/min
15-30 kg 35L/min
30-50 kg 40L/min
>50 kg 50L/min


Intervention code [1] 296662 0
Treatment: Devices
Intervention code [2] 296932 0
Treatment: Other
Comparator / control treatment
After induction of anaesthesia oxygen will be discontinued as per normal practice prior to intubation in children in emergency settings.
Control group
Active

Outcomes
Primary outcome [1] 300515 0
Hypoxia defined as oxygen saturations using pulse oximetry less than 90% or a decrease of 10% from pre-intubation oxygen saturation where 100% oxygen saturation can not be clinically achieved during pre-oxygenation.
Timepoint [1] 300515 0
After induction of anaesthesia and prior to intubation in children
Primary outcome [2] 300516 0
Proportion of successful first attempt intubations of success rate of intubation during emergency intubation. A single advanced airway manoeuvre beginning with the insertion of a device, such as a laryngoscope, into the patient’s mouth and ending when the device is removed from the patient’s mouth, or where there is a change in operator during the procedure even if the device is not removed.
Timepoint [2] 300516 0
During emergency intubation
Secondary outcome [1] 330177 0
Bradycardia - Pulse rate decreasing 2 standard deviations below normal for age as defined by the American Heart Association in the Paediatric Advanced Life Support (PALS) Provider Manual using pulse oximetry and cardiac monitoring via ECG leads.
Timepoint [1] 330177 0
After induction of anaesthesia and prior to intubation in children
Secondary outcome [2] 330178 0
Hypotension - systolic BP falling below fifth centile for age, as defined by the American Heart Association in the Paediatric Advanced Life Support (PALS) Provider Manual using non invasive blood pressure monitoring and when available arterial blood pressure monitoring
Timepoint [2] 330178 0
After induction of anaesthesia and prior to intubation in children
Secondary outcome [3] 330179 0
Number of mainstem bronchial intubations assessed by clinical judgement or x-ray. This will be assessed using clinician reports and medical records.
Timepoint [3] 330179 0
After intubation in children
Secondary outcome [4] 330180 0
Number of oesophageal intubation (passage of endotracheal tube into the oesophagus) recognised immediately and with late recognition as defined below. This will be assessed using clinician reports and medical records.
- Immediate Recognition: recognised in the first 60 seconds after initiation of ventilation through endotracheal tube.
- Late Recognition: recognised >60s after initiation of ventilation through endotracheal tube.
Timepoint [4] 330180 0
After intubation in children
Secondary outcome [5] 330181 0
Laryngospasm - Partial or complete airway obstruction, with oxygen desaturation caused by involuntary and sustained closure of the vocal cords and is not relieved by routine airway re-positioning, suctioning or insertion or nasal or oral airway. This will be assessed using clinician reports and medical records.
Timepoint [5] 330181 0
During or post intubation.
Secondary outcome [6] 330185 0
Cardiac arrest with or without return of spontaneous circulation assessed using medical records.
Timepoint [6] 330185 0
At any point during the emergency intubation process
Secondary outcome [7] 330186 0
Emesis with or without aspiration assessed using medical records.
Timepoint [7] 330186 0
At any point during the emergency intubation process
Secondary outcome [8] 330188 0
Malignant hyperthermia assessed using medical records.
Timepoint [8] 330188 0
At any point during the emergency intubation process
Secondary outcome [9] 330189 0
Pneumothorax or pneumomediastinum assessed using medical records.
Timepoint [9] 330189 0
At any point during the emergency intubation process

Eligibility
Key inclusion criteria
* Is aged less than 16 years at the time of randomisation
* Requires rapid sequence induction (RSI) or modified RSI* for emergency intubation and ventilation in either the emergency department or intensive care unit

* Modified RSI is defined as the provision of ventilatory support by bag-mask ventilation, or other method, during the pre-oxygenation phase of induction of anaesthesia
Minimum age
No limit
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Planned endo-tracheal tube changes
* Requires immediate intubation for loss of cardiac output or respiratory arrest.
* Location of intubation is outside the Emergency Department or Intensive Care Unit.
* Blocked nasal airway due to anatomical abnormality (e.g. Choanal atresia)
* Blocked nasal airway due to acute injury, trauma or disease (e.g. Severe facial trauma)


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 requiring emergency intubation in the intensive care or emergency department
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7132 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 7133 0
The Townsville Hospital - Douglas
Recruitment hospital [3] 7134 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 14894 0
4101 - South Brisbane
Recruitment postcode(s) [2] 14895 0
4814 - Douglas
Recruitment postcode(s) [3] 14896 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 295187 0
Charities/Societies/Foundations
Name [1] 295187 0
Emergency Medicine Foundation
Address [1] 295187 0
2/15 Lang Parade Milton QLD 4064
Country [1] 295187 0
Australia
Primary sponsor type
Hospital
Name
Lady Cilento Children's Hospital
Address
501 Stanley Street
South Brisbane
Queensland, Australia 4101
Country
Australia
Secondary sponsor category [1] 294015 0
Other Collaborative groups
Name [1] 294015 0
Paediatric Critical Care Research Group
Address [1] 294015 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] 294015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296538 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 296538 0
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] 296538 0
Australia
Date submitted for ethics approval [1] 296538 0
12/12/2016
Approval date [1] 296538 0
16/12/2016
Ethics approval number [1] 296538 0

Summary
Brief summary
Children may present to an emergency department with life threatening conditions that require immediate treatment to support their breathing to allow enough oxygen to be supplied to the body. In these circumstances a child is anesthetized and intubated, this process is associated with a high risk for low oxygen levels (14%) in the body or low blood pressure or heart rate. Newer methods to avoid these risks and improve patient safety are important to investigate. In this study we investigate a new approach called Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE); to prevent a drop in oxygen levels during intubation using nasal high flow oxygen delivery. This method allows continued post induction oxygen delivery during attempted intubation, whereas once the face mask is removed during traditional intubation the oxygen reservoir is no longer renewed and lower O2 levels can occur. We have tested this method in children with healthy lungs undergoing anaesthesia for elective surgery, and we found that we can maintain oxygen levels more than twice as long as using standard intubation methods. These findings would allow the operator in emergency settings more time and a safer condition to secure the airway in a sick child. It is though that by providing oxygen throughout the intubation adverse events such as oxygen desaturation are reduced and he number of successful first intubation attempts increases. The high flow system used for the THRIVE method is not new and is often used in hospitals to treat children with respiratory illness such as bronchiolitis.

Therefore we aim to compare the addition of the THRIVE method to standard intubation practice with the current standard practice to intubate a child in an emergency situation. We aim to demonstrate that the new THRIVE method will reduce the risk for low oxygen levels in the blood and prevents low blood pressure associated with intubation.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71202 0
A/Prof Andreas Schibler
Address 71202 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
Paediatric Critical Care Research Group
62 Graham Street, South Brisbane QLD 4101
Country 71202 0
Australia
Phone 71202 0
+61 7 3068 1111
Fax 71202 0
Email 71202 0
a.schibler@uq.edu.au
Contact person for public queries
Name 71203 0
A/Prof Andreas Schibler
Address 71203 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
Paediatric Critical Care Research Group
62 Graham Street, South Brisbane QLD 4101
Country 71203 0
Australia
Phone 71203 0
+61 7 3068 1111
Fax 71203 0
Email 71203 0
a.schibler@uq.edu.au
Contact person for scientific queries
Name 71204 0
A/Prof Andreas Schibler
Address 71204 0
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
Paediatric Critical Care Research Group
62 Graham Street, South Brisbane QLD 4101
Country 71204 0
Australia
Phone 71204 0
+61 7 3068 1111
Fax 71204 0
Email 71204 0
a.schibler@uq.edu.au