Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000799358
Ethics application status
Approved
Date submitted
18/02/2017
Date registered
31/05/2017
Date last updated
15/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial examining the use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for children undergoing microlaryngoscopy and bronchoscopy
Scientific title
A randomised controlled clinical trial to evaluate the incidence and severity of oxygen desaturation events when using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to oxygenate paediatric patients undergoing microlaryngoscopy and bronchoscopy
Secondary ID [1] 290863 0
None
Universal Trial Number (UTN)
U1111-1188-7711
Trial acronym
THRIVE-MLB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory disease 301558 0
Condition category
Condition code
Anaesthesiology 301271 301271 0 0
Anaesthetics
Respiratory 301272 301272 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will be randomly allocated to intervention or control ventilation groups.

The intervention group will receive oxygen via the Optiflow (a humidifier that can deliver high flow gas at body temperature), THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) at the appropriate weight related flow rate, using commercially available nasal cannula (Fisher & Paykel Healthcare Ltd).

The control group will receive oxygen via a standard nasopharyngeal tube with a flow rate of 6-8 L/min (see below).

All participants will receive a standardised anaesthetic consisting of induction with oxygen and sevoflurane gas and topical lignocaine spray to the airway with anaesthesia maintained using total intravenous anaesthesia (TIVA) with propofol and remifentanil, as per standard protocols.

Children in both groups will breathe spontaneously. Monitoring will apply to all children and will include ECG, SpO2, blood pressure, transcutaneous carbon dioxide, temperature, capnography and gas monitoring.

All participants will be under the care of a consultant paediatric anaesthetist experienced in TIVA. Participants will be oxygenated using Optiflow THRIVE or a standard nasopharyngeal tube for the duration of the surgical procedure and in recovery as per standard protocols.

Optiflow gas flow rate is based on the child's body weight as follows:-

Weight up to 5 Kg use a gas flow rate of 20 L/min
Weight is greater than 5 Kg up to and including 10 Kg use a gas flow rate of 25 L/min
Weight is greater than 10 Kg up to and including 15 Kg use a gas flow rate of 30 L/min
Weight is greater than 15 Kg up to and including 20 Kg use a gas flow rate of 35 L/min
Weight is greater than 20 Kg up to and including 25 Kg use a gas flow rate of 40 L/min
Weight is greater than 25 Kg up to and including 30 Kg use a gas flow rate of 45 L/min
Weight is greater than 30 Kg up to and including 40 Kg use a gas flow rate of 50 L/min
Weight is greater than 40 Kg up to and including 50Kg use a gas flow rate of 60 L/min
Weight is greater than 50 Kg use a gas flow rate of 70 L/min
Intervention code [1] 296812 0
Treatment: Devices
Comparator / control treatment
Children will be randomly allocated to intervention or control ventilation groups.

The control group will receive oxygen via standard nasopharyngeal tube with a flow rate of 6-8 L/min.

All participants will receive a standardised anaesthetic consisting of induction with oxygen with sevoflurane gas and topical lignocaine spray to the airway with anaesthesia maintained using total intravenous anaesthesia (TIVA) with propofol and remifentanil, as per standard protocols.

Children in both groups will breathe spontaneously. Monitoring will apply to all children and will include ECG, SpO2, blood pressure, transcutaneous carbon dioxide, temperature, capnography and gas monitoring.

All participants will be under the care of a consultant paediatric anaesthetist experienced in TIVA. Participants will be oxygenated using Optiflow THRIVE or a standard nasopharyngeal tube for the duration of the surgical procedure and in recovery as per standard protocols.
Control group
Active

Outcomes
Primary outcome [1] 300687 0
The proportion of patients in each group with hypoxia (desaturation <90% for 45 seconds or longer) using a pulse oximeter
Timepoint [1] 300687 0
Any time throughout the duration of the operation (time from surgical start until finish)
Secondary outcome [1] 330607 0
Epistaxis (nose bleed) with evidence of blood loss.
Timepoint [1] 330607 0
Anytime after the insertion of the nasopharyngeal airway or the nasal prongs until discharge from hospital.
Secondary outcome [2] 330608 0
Sinus Infections with pain typical of sinusitis and purulent nasal discharge and/or temperature elevation above 37 degrees Celsius measure by oral thermometer.
Timepoint [2] 330608 0
Any time after the insertion of the nasopharyngeal airway or the nasal prongs until one month after the operation.
Secondary outcome [3] 330609 0
Delays during surgery as compared to mean operating room time for this procedure recorded on the hospital database. Operating room time is recorded from entrance to departure from the operating room. Secondary times can also be calculated from recordings of start of anaesthesia, start of surgery and end of surgery.
Timepoint [3] 330609 0
From entrance to departure from the operating room, which is recorded in the hospital database. Start of anaesthesia is defined as the time the nasopharyngeal airway or nasal prongs are inserted.
Secondary outcome [4] 331601 0
The need to deploy an oxygenation rescue intervention including facemask ventilation, emergency translaryngeal intubation, and emergency front-of-neck access.
Timepoint [4] 331601 0
Any time after the insertion of the nasopharyngeal airway or the nasal prongs until the end of the operation.
Secondary outcome [5] 335122 0
Carbon dioxide levels measured by transcutaneous carbon dioxide monitoring plus capnography. Capnography will record the maximum value above 5.7kPa , and the absolute time of the increase in ET CO2 above 5.7 kPa. The transcutaneous CO2 (tcCO2) will record the rate of change of CO2 increase in the control and study groups, recorded as mmHg/min.
Timepoint [5] 335122 0
Throughout the course of the general anaesthetic.
Secondary outcome [6] 335123 0
Throat infections associated with pain, crying, increased temperature (<37 degrees Celsius) and signs of inflammation and/or discharge.
Timepoint [6] 335123 0
Any time after the insertion of the nasopharyngeal airway or nasal prongs until one month after the operation.
Secondary outcome [7] 335124 0
Chest infections with cough, sputum, increased temperature (<37 degrees Celsius). and chest x-ray changes
Timepoint [7] 335124 0
Any time after the insertion of the nasopharyngeal airway or the nasal prongs until one month after the operation.
Secondary outcome [8] 335423 0
Total time spent under 90% oxygen saturation as measured by pulse oximeter.
Timepoint [8] 335423 0
Any time throughout the duration of the operation (time from surgical start until finish)

Eligibility
Key inclusion criteria
The principal inclusion criteria are male and female patients under the age of 13 years who are undergoing Microlaryngoscopy and Bronchoscopy.
Minimum age
No limit
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are patients with a BMI (body mass index) greater than 35, severe nasal obstruction, patients with defects within the anterior skull base, inability to obtain informed parental consent, and emergency MLB when the time from being informed about the trial and time of surgery is less than 24 hours.
Children undergoing laser, diathermy or other forms of treatment associated with fires on or around their airway.

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)
Participant randomisation will be undertaken centrally by Clinical Solutions NZ Ltd (CSL) using a computer generated randomisation codes.

Allocation will be concealed using a set of opaque sealed envelopes which will be opened only after participant enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be completed using computer generation and will be stratified by study site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size and Power
We undertook a preliminary study of the incidence of desaturation in paediatric patients undergoing MLB using the current standard technique of nasopharyngeal oxygenation. The primary outcome was observed in 31% of patients. Assuming a 25% absolute improvement in the incidence of intraoperative desaturation and a superiority trial design, the study will require 125 patients per arm of the study with alpha=0.05 and 1-beta=0.9.

Statistical Methods
Statistical analysis for the primary outcome (the proportion of patients in each group with desaturation <90% for 45 seconds or longer) will be made using chi-square test. A post-hoc analysis will be undertaken using binary logistic regression analysis. Three of the secondary outcome variables are binary and will be analysed in the same manner as the primary outcome. Total time spent under 90% saturation per patient will be compared between the groups using t-test (if the data are normally distributed) and a post-hoc multiple regression analysis will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
3/12/2019
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 8556 0
New Zealand
State/province [1] 8556 0
Auckland

Funding & Sponsors
Funding source category [1] 295295 0
Charities/Societies/Foundations
Name [1] 295295 0
Starship Foundation
Country [1] 295295 0
New Zealand
Primary sponsor type
Government body
Name
Auckland District Health Board
Address
Auckland City Hospital
2 Park Road, Grafton,
Auckland 1023.
Country
New Zealand
Secondary sponsor category [1] 294115 0
None
Name [1] 294115 0
Address [1] 294115 0
Country [1] 294115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296631 0
Health and Disability Ethics Committee
Ethics committee address [1] 296631 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 296631 0
New Zealand
Date submitted for ethics approval [1] 296631 0
31/05/2017
Approval date [1] 296631 0
03/08/2017
Ethics approval number [1] 296631 0

Summary
Brief summary
Children with suspected airway disease undergo Microlaryngoscopy and Bronchoscopy (MLB); this is a diagnostic procedure to visualise airway anatomy from the larynx to the bronchi. MLB is a "shared airway" procedure and in order for the surgeon to visualise the airway, the trachea cannot be intubated. The anaesthetist instead places a tube through the nose to deliver oxygen to the pharynx.
This ventilation technique relies upon the ability of the patient to breathe spontaneously whilst anaesthetised. Quite often the patient will stop breathing in the middle of the procedure (apnoea) and rapidly becomes hypoxic. This is particularly hazardous in the paediatric population as they have a shortened apnoeic period. We have shown in a preliminary study that 1/3 of children undergoing MLB procedures frequently have unstable apnoeic oxygen desaturations which are potentially life threatening.
We have also recently shown that in adult patients, a non-invasive technique involving giving high-flow humidified oxygen through the nose could continue to provide oxygen to patients during periods of apnoea thereby preventing oxygen desaturation. The purpose of the present study is to compare the incidence and severity of oxygen desaturation events during paediatric MLB under current conditions of spontaneous ventilation using a naso-pharyngeal tube, or using high-flow humidified nasal oxygen. We also hypothesize that humidified nasal oxygen would be associated with reduced drying of the lining of the throat and lungs. Secondary objectives of this trial is to assess whether use of humidified oxygen reduces the incidence of nasal bleeding, sinus, airway and lung infections and prolonged operation times.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71542 0
Dr Paul Baker
Address 71542 0
Department of Paediatric Anaesthesia, Starship Children's Hospital,
2 Park Road, Grafton, Auckland 1023, New Zealand.
Country 71542 0
New Zealand
Phone 71542 0
+6421977392
Fax 71542 0
Email 71542 0
paul@airwayskills.co.nz
Contact person for public queries
Name 71543 0
Dr Paul Baker
Address 71543 0
Department of Paediatric Anaesthesia,
Starship Children's Hospital,
2 Park Road, Grafton, Auckland 1023, New Zealand
Country 71543 0
New Zealand
Phone 71543 0
+6493074949 Extension 24400#
Fax 71543 0
Email 71543 0
paul@airwayskills.co.nz
Contact person for scientific queries
Name 71544 0
Dr Paul Baker
Address 71544 0
Department of Paediatric Anaesthesia, Starship Children's Hospital,
2 Park Road, Grafton, Auckland 1023, New Zealand.
Country 71544 0
New Zealand
Phone 71544 0
+6421977392
Fax 71544 0
Email 71544 0
paul@airwayskills.co.nz

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.