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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Hypoxia (Desaturation)

Condition category

Condition code

Anaesthesiology

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]

Prevention

Intervention code [2]

Treatment: Drugs

Intervention code [3]

Treatment: Devices

Comparator / control treatment

No Nasal oxygen (as per routine practice)

Control group

Active

Outcomes

Primary outcome [1]

Degree of hypoxaemia detected by pulse oximetry during intubation

Timepoint [1]

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]

The variation in Bispectral Analysis (BIS) during and subsequent to intubation

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

SPANZA
Society for Paediatric Anaesthesia in New Zealand and Australia

Address [1]

PO Box 180.
MORISSET
NSW
Australia
2264

Country [1]

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]

Individual

Name [1]

Dr James Dalby-Ball

Address [1]

Department of Anaesthesia Starship Hospital
2 Park Road
Grafton
Auckland
New Zealand
1023

Country [1]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Adjunct Professor Brian Anderson, MBChB, PhD, DipObst, FANZCA, FJFICM

Address [1]

Paediatric Intensive Care Unit,
Starship Childrens Health
2 Park Road
Grafton
Auckland
New Zealand
1023

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Dr John Thompson,

Address [2]

Department of Paediatrics, University of Auckland.
Level 12 Auckland Support Building
Auckland City Hospital,
2 Park Road
Grafton,
Auckland
New Zealand
1010

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6145

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

01/08/2012

Ethics approval number [1]

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

Dr Paul Baker

Address

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

Phone

+64 021977392

Fax

paul@airwayskills.co.nz

Contact person for public queries

Name

Paul Baker,

Address

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

Phone

+64 021977392

Fax

paul@airwayskills.co.nz

Contact person for scientific queries

Name

Paul Baker

Address

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

Phone

+64 021977392

Fax

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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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