Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001101774
Ethics application status
Approved
Date submitted
18/09/2013
Date registered
2/10/2013
Date last updated
2/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasal oxygen therapy during paediatric direct laryngoscopy and endotracheal intubation.
Scientific title
In children undergoing a general anaesthetic does supplemental nasal oxygen therapy , compared to no supplemental oxygen, prevent hypoxia during the induction - intubation -ventilation period.
Secondary ID [1] 283244 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxia (Desaturation) 290116 0
Condition category
Condition code
Anaesthesiology 290498 290498 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard Paediatric sized nasal prongs (Fisher-Paykel) as used throughout Starship Hospital , Auckland , will be applied to the patient after induction of anaesthesia.

They are single use devices and will be applied to all patients in the study to ensure blinding is maintained.

The group randomised to receive oxygen through the prongs will have these devices connected to a cylinder oxygen supply providing a flow of 5L/min , giving an fractional inspired oxygen concentration of 35%.

These will remain in place until intubation has been confirmed through the use of end-tidal-carbon dioxide monitoring and then removed.
Intervention code [1] 287971 0
Prevention
Intervention code [2] 287972 0
Treatment: Drugs
Intervention code [3] 287973 0
Treatment: Devices
Comparator / control treatment
No Nasal oxygen (as per routine practice)
Control group
Active

Outcomes
Primary outcome [1] 290515 0
Degree of hypoxaemia detected by pulse oximetry during intubation
Timepoint [1] 290515 0
From removal of Oxygen mask to a point following intubation where the saturation as measured by pulse oximetry has returned to pre - induction levels
Secondary outcome [1] 304702 0
The variation in Bispectral Analysis (BIS) during and subsequent to intubation
Timepoint [1] 304702 0
From removal of oxygen mask to establishment of adequate ventilation and stable oxygen saturations as described in the primary outcome.

Eligibility
Key inclusion criteria
Children aged 1 year to 16 years
ASA 1 and 2 only
Requiring High Resolution CT of the Chest and Bronchoscopy (ie. require intubation)
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Critical illness ASA >3
Critical / anticipated difficult airway
Ongoing need for supplemental oxygen pre-study
BMI >30
Acute Respiratory Tract Infection
Previous anaesthesia complication that prevents inclusion in the study as determined by anaesthetist
Choanal atresia

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruited to the study when booked for High Res CT as inclusion/exclusion criteria allows.
A randomisation procedure has been performed and sequentially numbered study packs prepared containing all the information including details of the intervention (which remains concealed from the anaesthetist and is given to an assistant). This divides the 40 patients into two groups:
Treatment arm A: Receives nasal oxygen during intubation
Treatment arm B: Does not receive nasal oxygen during intubation
To ensure allocation concealment all patients will have nasal prongs placed and an assistant will connect the prongs to either oxygen or will leave the connector open to air. This is out of sight of the anaesthetist so ensuring concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dr John Thomson, Senior Research Fellow , University of Auckland has performed the randomisation procedure using GraphPad Software (Registered trademark), Inc, La Jolla, California, USA .

The results of this have been given to an assistant who prepares numbered envelopes which are to be given to the anaesthesia assistant when undertaking the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Power Analysis:
We are planning a study with 20 experimental subjects and 20 control subjects. In a previous study the response within each subject group was normally distributed with standard deviation 2. We will be able to detect a true difference in the mean response of experimental and control subjects of -2.105 or 2.105 with probability (power) 0.9. The Type I error probability associated with this test of the null hypothesis that the population means of the experimental and control groups are equal is 0.05.
Statistical Analysis:
Differences in mean times in hypoxia will be tested using 2-sided t-tests. We will also carry out regressions using generalised linear models to control for potential confounders including sex and age.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
1/09/2013
Date of last participant enrolment
Anticipated
1/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5418 0
New Zealand
State/province [1] 5418 0
Auckland

Funding & Sponsors
Funding source category [1] 287983 0
Charities/Societies/Foundations
Name [1] 287983 0
SPANZA
Society for Paediatric Anaesthesia in New Zealand and Australia
Country [1] 287983 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Baker
Address
Senior Lecturer, Department of Anaesthesiology,
The University of Auckland.
Level 12 Auckland Support Building
Auckland City Hospital,
2 Park Road
Grafton,
Auckland
New Zealand
1010
Country
New Zealand
Secondary sponsor category [1] 286703 0
Individual
Name [1] 286703 0
Dr James Dalby-Ball

Address [1] 286703 0
Department of Anaesthesia Starship Hospital
2 Park Road
Grafton
Auckland
New Zealand
1023
Country [1] 286703 0
New Zealand
Other collaborator category [1] 277619 0
Individual
Name [1] 277619 0
Adjunct Professor Brian Anderson, MBChB, PhD, DipObst, FANZCA, FJFICM
Address [1] 277619 0
Paediatric Intensive Care Unit,
Starship Childrens Health
2 Park Road
Grafton
Auckland
New Zealand
1023
Country [1] 277619 0
New Zealand
Other collaborator category [2] 277620 0
Individual
Name [2] 277620 0
Dr John Thompson,
Address [2] 277620 0
Department of Paediatrics, University of Auckland.
Level 12 Auckland Support Building
Auckland City Hospital,
2 Park Road
Grafton,
Auckland
New Zealand
1010
Country [2] 277620 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289912 0
Northern X Regional Ethics Committee
Ethics committee address [1] 289912 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6145
Ethics committee country [1] 289912 0
New Zealand
Date submitted for ethics approval [1] 289912 0
Approval date [1] 289912 0
01/08/2012
Ethics approval number [1] 289912 0
NTX 11 11 103

Summary
Brief summary
Avoiding hypoxia through the administration of oxygen is a fundamental part of safe anaesthesia. Giving oxygen before induction (pre-oxygenation) , during ventilation with a mask and then following intubation is standard practice throughout the world. Oxygen levels are then maintained throughout the remainder of the anaesthetic and during the recovery period until the patient is conscious and capable of breathing spontaneously on air.
When induction of a general anaesthetic occurs, the placement of an endotracheal tube is often required to maintain a safe and secure airway throughout the anaesthetic. Traditionally, this procedure is performed by direct laryngoscopy using a laryngoscope , which allows the anaesthetist to visualise the airway and place the endotracheal tube into the correct part of the airway.. Direct laryngoscopy normally occurs without the administration of supplementary oxygen. Hypoxia is avoided by preoxygenation and de-nitrogenation of the lungs prior to this process. A skilled anaesthetist is then required to complete this procedure before the patient experiences hypoxia.
Despite these steps to prevent hypoxia, brief periods do occasionally occur during intubation although these are rapidly corrected by the anaesthetist using 100% oxygen following successful intubation. Some patient groups are at risk of hypoxia for a number of reasons and children are one of these due to smaller reserves of oxygen in the lungs. Disease processes and difficulty establishing a secure intubated airway (e.g. multiple attempts required ) can add to the risk of hypoxia in this group.
The aim of this study is to examine the efficacy of nasal oxygen throughout direct laryngoscopy and intubation in children. By administering nasal oxygen (which avoids interference with the anaesthetist's view of the airway) we hope to avoid hypoxic events. This has potential benefits for children during resuscitation, intensive care, anaesthesia and emergency medicine.

This study is a prospective , randomised control trial with the following null hypothesis:

There is no statistical difference in the incidence, duration and severity of hypoxia (SpO2 < 94%) following direct laryngoscopy and endotracheal intubation between those children administered nasal oxygen and those not receiving nasal oxygen

The patients will be closely monitored for signs of hypoxia using continuous pulse oximetry. Continual bispectral index monitoring will also be used to monitor for awareness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43050 0
Dr Paul Baker
Address 43050 0
Department of Anaesthesiology,
The University of Auckland.
Level 12 Auckland Support Building
Auckland City Hospital,
2 Park Road
Grafton,
Auckland
New Zealand
1010
Country 43050 0
New Zealand
Phone 43050 0
+64 021977392
Fax 43050 0
Email 43050 0
[email protected]
Contact person for public queries
Name 43051 0
Dr Paul Baker,
Address 43051 0
Department of Anaesthesiology,
The University of Auckland.
Level 12 Auckland Support Building
Auckland City Hospital,
2 Park Road
Grafton,
Auckland
New Zealand
1010
Country 43051 0
New Zealand
Phone 43051 0
+64 021977392
Fax 43051 0
Email 43051 0
[email protected]
Contact person for scientific queries
Name 43052 0
Dr Paul Baker
Address 43052 0
Department of Anaesthesiology,
The University of Auckland.
Level 12 Auckland Support Building
Auckland City Hospital,
2 Park Road
Grafton,
Auckland
New Zealand
1010
Country 43052 0
New Zealand
Phone 43052 0
+64 021977392
Fax 43052 0
Email 43052 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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