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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] 280624 0
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 286635 0
Condition category
Condition code
Anaesthesiology 286919 286919 0 0
Anaesthetics
Respiratory 286936 286936 0 0
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] 285022 0
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] 287274 0
Primary endpoint will be the total of respiratory complications which will be assessed via clinical assessments
Timepoint [1] 287274 0
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] 297804 0
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] 297804 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285382 0
Charities/Societies/Foundations
Name [1] 285382 0
Society of Paediatric Anaesthesia Australia and New Zealand (SPANZA)
Address [1] 285382 0
PO Box 180
Morisset NSW 2264
Country [1] 285382 0
Australia
Funding source category [2] 288340 0
Government body
Name [2] 288340 0
NHMRC
Address [2] 288340 0
Canberra, GPO BOX 1421
ACT 2601
Country [2] 288340 0
Australia
Funding source category [3] 288341 0
Charities/Societies/Foundations
Name [3] 288341 0
ANZCA
Address [3] 288341 0
Melbourne
630 St Kilda Rd
VIC 3004
Country [3] 288341 0
Australia
Funding source category [4] 288342 0
Charities/Societies/Foundations
Name [4] 288342 0
PMH Foundation
Address [4] 288342 0
Hamilton Rd
Subiaco, WA 6008
Country [4] 288342 0
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] 284240 0
University
Name [1] 284240 0
The University of Western Australia
Address [1] 284240 0
35 Stirling Highway
Crawley WA 6009
Perth
Country [1] 284240 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287400 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 287400 0
Roberts Road
SUBIACO, WA 6008
Ethics committee country [1] 287400 0
Australia
Date submitted for ethics approval [1] 287400 0
Approval date [1] 287400 0
24/05/2012
Ethics approval number [1] 287400 0
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 34272 0
Prof Britta Regli-von Ungern-Sternberg
Address 34272 0
Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
Subiaco, WA 6008
Country 34272 0
Australia
Phone 34272 0
+61893408109
Fax 34272 0
Email 34272 0
britta.regli-vonungern@health.wa.gov.au
Contact person for public queries
Name 17519 0
Prof Britta Regli-von Ungern-Sternberg
Address 17519 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital for Children
Roberts Road
Subiaco, WA 6008
Country 17519 0
Australia
Phone 17519 0
+61893408109
Fax 17519 0
Email 17519 0
britta.regli-vonungern@health.wa.gov.au
Contact person for scientific queries
Name 8447 0
Prof Britta Regli-von Ungern-Sternberg
Address 8447 0
Department of Anaesthesia and Pain Management
Princess Margaret Hospital for Children
Roberts Road
Subiaco, WA 6008
Country 8447 0
Australia
Phone 8447 0
+61893408109
Fax 8447 0
Email 8447 0
britta.regli-vonungern@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary