ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000608864

Ethics application status

Approved

Date submitted

5/06/2012

Date registered

6/06/2012

Date last updated

27/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Safer anaesthesia for children with asthma (SAFA trial): Can exhaled nitric oxide (NO) levels predict children at risk for respiratory complications? – a pilot study

Scientific title

Safer anaesthesia for children with asthma (SAFA trial): Can exhaled nitric oxide (NO) levels predict children at risk for respiratory complications? – a pilot study

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

SAFA Trial

Linked study record

Health condition

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

This study aims to assess the usefulness of expiratory nitric oxide (eNO) to detect children with a high risk for perioperative respiratory adverse events

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

non invasive measurement of exhaled NO preoperatively with the aid of a Niox Mino (Aerocrine, Sweden). The child has to exhale into a mouthpiece attached to the Niox Mino. Only one measurement will be taken at the preoperative assessment. In childen < 130cm height, the measurement takes 6s, while the NO measurement in children of 130cm or taller the measurement takes 10 s.
The patient will be monitores for respiratory adverse events throughout the perioperative period until the patient is discharged from the post anaesthesia care unit.

Intervention code [1]

Not applicable

Comparator / control treatment

NO will be measured in children with risk factors for respiratory adverse events and in healthy children as a control group.

Control group

Active

Outcomes

Primary outcome [1]

Primary endpoint will be the total of respiratory complications which will be assessed via clinical assessments

Timepoint [1]

The respiratory complications will be assessed in the entire perioperative period until the patient is discharged from the post anaesthesia care unit.

Secondary outcome [1]

Secondary endpoints will be the occurrence and frequency of the individual respiratory complications in in the perioperative period.
Presence of respiratory complications is defined by the presence of one or more of the following:
-Bronchospasm
-Laryngospasm,
-Severe coughing
-Desaturation < 95%
-Airway obstruction
-stridor

The outcomes will be assessed via clinical assessment.

Timepoint [1]

The respiratory complications will be assessed in the entire perioperative period until the patient is discharged from the post anaesthesia care unit.

Eligibility

Key inclusion criteria

Children, aged 4 to 16 years, male or female undergoing elective minor surgery
100 healthy children with no risk factors
180 children with 2 or more risk factors for developing PRAE:
-cold or flu currently or in the last 2 weeks
-eczema at present or in the past
-wheezing in the last 12 months
-asthma in the past (if wheezing in the last 12 months is negative)
-dry nocturnal cough
-wheezing at exercise
-family history of asthma (mother, father and/or siblings)
-family history of eczema (mother, father and/or siblings)
-family history of hay fever (mother, father and/or siblings)
-passive smoking (mother, father, caregiver)

Minimum age

4 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children with airway malformations
Pre-medication of Midazolam
Children with Neurological imparement
Children with Cardiac Disease
Children who are uncooperative

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

24/05/2012

Actual

28/05/2012

Date of last participant enrolment

Anticipated

Actual

21/11/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

280

Accrual to date

Final

280

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Society of Paediatric Anaesthesia Australia and New Zealand (SPANZA)

Address [1]

PO Box 180
Morisset NSW 2264

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NHMRC

Address [2]

Canberra, GPO BOX 1421
ACT 2601

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

ANZCA

Address [3]

Melbourne
630 St Kilda Rd
VIC 3004

Country [3]

Australia

Funding source category [4]

Charities/Societies/Foundations

Name [4]

PMH Foundation

Address [4]

Hamilton Rd
Subiaco, WA 6008

Country [4]

Australia

Primary sponsor type

Hospital

Name

Department of Anaesthesia and Pain Management

Address

Princess Margaret Hospital for Children
Roberts Road
Subiaco, WA 6008

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Western Australia

Address [1]

35 Stirling Highway
Crawley WA 6009
Perth

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children Ethics Committee

Ethics committee address [1]

Roberts Road
SUBIACO, WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/05/2012

Ethics approval number [1]

1933EP

Summary

Brief summary

Australia has one of the highest rates of asthma and allergy in the world. Both are strong
risk factors for perioperative respiratory adverse events (PRAE), which are the leading
cause of critical incidents in paediatric anaesthesia
It is already well established that the severity of current asthma, as well as the effect of
therapeutic asthma drugs, can be assessed by monitoring exhaled nitric oxide levels. In
addition, exhaled nitric oxide levels can be easily measured in children using a simple
non-invasive device.
The aim of this study is to assess whether the measurement of exhaled nitric oxide levels
may be used to identify children at a particularly high risk for respiratory complications.
By identifying this at risk group, the anaesthetist will be able to make a more informed
decision regarding the optimal time for surgery, as well as institute the appropriate
medical management prior to surgery for each individual child. Optimising the
anaesthesia management for this high-risk group would be expected to lead to a
reduction in perioperative respiratory complications. Since respiratory complications are
one of the leading causes for morbidity and mortality in paediatric anaesthesia, such a
reduction would lead to a major improvement in outcomes for high-risk children
undergoing anaesthesia. In addition to an anticipated reduction in the occurrence of
respiratory complications, this study has the potential to reduce the health costs
associated with the occurrence of these complications (e.g. unplanned hospital
admissions, prolonged hospital stay, additional treatment). We also anticipate that our
findings will lead to an improvement in waiting list times, aid the scheduling of surgery,
assist in the preoperative identification of children at a higher risk of PRAE and aid the
planning of appropriate preventive strategies, thereby reducing the cancellation of
surgery. Cancellations have associated adverse economic impacts for the health care
system, cause enormous emotional and financial burdens for the child and his/her family
as well as engender lack of confidence in the public health care system.
To conclude, we anticipate that this study will improve the safety of children undergoing
anaesthesia by providing early detection of high-risk patients which will aid the optimal timing
of surgery, enhance the anaesthesia management of our patients, help reduce the costs of
prolonged hospital stay associated with peroperative complications and optimise waitlist
times. Further benefits may include a reduced requirement for critical care facilities, a
decrease in unexpected intensive care admissions and enhanced child/parent satisfaction
rates.

Trial website

Trial related presentations / publications

Anaesthesia. 2015 Oct;70(10):1160-4. doi: 10.1111/anae.13123. Epub 2015 Jun 1.
Prediction of peri-operative adverse respiratory events in children: the role of exhaled nitric oxide.
Ramgolam A1,2, Hall GL2, Zhang G3, Hegarty M1, von Ungern-Sternberg BS1,4.

Public notes

Contacts

Principal investigator

Name

Prof Britta Regli-von Ungern-Sternberg

Address

Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

Contact person for public queries

Name

Britta Regli-von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management
Princess Margaret Hospital for Children
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

Contact person for scientific queries

Name

Britta Regli-von Ungern-Sternberg

Address

Department of Anaesthesia and Pain Management
Princess Margaret Hospital for Children
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.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

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Documents added automatically

No additional documents have been identified.

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