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Trial registered on ANZCTR


Registration number
ACTRN12610000252011
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
24/03/2010
Date last updated
12/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Control Trial: Intravenous versus inhalational induction in infants and children
(0-8 years) with a high risk for respiratory complications undergoing minor elective surgical procedures with laryngeal mask airways
Scientific title
Randomised Control Trial: Intravenous versus inhalational induction in infants and children
(0-8 years) with a high risk for respiratory complications undergoing minor elective surgical procedures with laryngeal mask airways
Secondary ID [1] 1513 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory complications following inhalational or intravenous induction of anaesthesia 256964 0
Condition category
Condition code
Anaesthesiology 257107 257107 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intravenous induction of anaesthesia with intravenous propofol (as per attending anaesthetist 2-5 mg/kg). The induction of anaesthesia is a very brief one/off intervention (approx. 2 min).
Intervention code [1] 256141 0
Treatment: Drugs
Comparator / control treatment
inhalational induction of anaesthesia
The induction of anaesthesia is a very brief one/off intervention (approx. 2 min).
Control group
Active

Outcomes
Primary outcome [1] 258002 0
Incidence of respiratory complications in the perioperative period
Presence of perioperative respiratory complication as defined by one or more of the following:
Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.
The presence/absence of respiratory complications will be recorded during the time of anaesthesia and the time spent in recovery. The overall presence of respiratory complications will be taken for the analysis.
Timepoint [1] 258002 0
intraoperatively until discharge from the recovery area
Secondary outcome [1] 263556 0
occurrence and frequency of the individual respiratory complications in both intra-operatively and in the recovery area.
The outcome will be assessed by clinical monitoring
Timepoint [1] 263556 0
intraoperatively until discharge from the recovery area

Eligibility
Key inclusion criteria
Children, aged 0 to 8 years, male or female undergoing elective minor surgery with 2 or more risk factors:8 1. Cold or flu currently or in the last 2 weeks 2. Eczema at present or in the past 3. Wheezing in the last 12 months 4. Asthma in the past (if wheezing in the last 12 months is negative) 5. Dry night cough 6. Bronchial hyperreactivity at exercise 7. Family history of asthma (mother, father and/or siblings) 8. Family history of eczema (mother, father and/or siblings) 9. Family history of hayfever (mother, father and/or siblings) 10. Passive smoking (mother, father, caregiver) These patients are undergoing the following types of procedures: magnetic resonance imaging (MRI), eye surgery, endoscopy, minor orthopaedic, grommets, minor general surgery and minor plastics procedures.
Minimum age
No limit
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known cardiac disease, airway or thoracic malformations, syndrome, neurological disorder, need for premedication, contraindication for i.v. or inhalational induction and/or for laryngeal mask airway (LMA) use as assessed by an anaesthetist independent of the study team. Any surgery involving the upper airway, chest or abdomen

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)
All patients will be recruited at the pre-anaesthetic visit. Only patients who meet the inclusion criteria for the study will be enrolled and only after informed consent is given voluntarily by the parent/guardian. The patients will be randomised by computer generated block randomisation. The participant will be assigned the next available Participant Number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients will be randomised by computer generated block randomisation. Following written informed consent, the participant will be assigned the next available Participant Number. The Participant Number will correspond to a numbered randomisation envelope. The randomisation is concealed in the closed envelope and will only be opened by the anaesthetist in charge of the patient at induction of anaesthesia. The participant number will be used to identify the patient for the duration of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
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
Recruitment hospital [1] 5020 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 256644 0
Hospital
Name [1] 256644 0
Princess Margaret Hospital for Children
Address [1] 256644 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country [1] 256644 0
Australia
Funding source category [2] 288363 0
Charities/Societies/Foundations
Name [2] 288363 0
Princess Margaret Hospital Foundation
Address [2] 288363 0
Princess Margaret Hospital Foundation
Level 1,
68 Hay Street
Subiaco
WA 6008
Australia
Country [2] 288363 0
Australia
Funding source category [3] 288364 0
Government body
Name [3] 288364 0
NHMRC
Address [3] 288364 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [3] 288364 0
Australia
Primary sponsor type
Individual
Name
Britta Regli-von Ungern
Address
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country
Australia
Secondary sponsor category [1] 255931 0
Individual
Name [1] 255931 0
Neil Chambers
Address [1] 255931 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country [1] 255931 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258668 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 258668 0
Princess Margaret Hospital for Children Ethics Committee
Level 1
Children’s Clinical Research Facility
Princess Margaret Hospital
Roberts Road
SUBIACO WA 6008
Ethics committee country [1] 258668 0
Australia
Date submitted for ethics approval [1] 258668 0
11/03/2010
Approval date [1] 258668 0
20/05/2010
Ethics approval number [1] 258668 0
1787/EP

Summary
Brief summary
Despite the development of anaesthesia management guidelines, perioperative respiratory adverse events (PRAE) remain a major cause of morbidity and mortality during paediatric anaesthesia, causing more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. In a previous cohort study in over 9000 children, we identified several risk factors (current or recent upper respiratory tract infection, wheezing more than 3 times in the last 12 months, eczema, nocturnal dry cough, a family history of asthma, eczema, rhinitis or passive smoking) which can help in every day clinical practice to identify the children at a particularily high risk for PRAE.

A recent large cohort study conducted by the anaesthetic department of Princess Margaret Hospital, “Risk assessment for respiratory complications in paediatric anaesthesia” by von Ungern-Sternberg, Habre, Boda, Rebmann, Johnson, Sly, and Chambers, identified the type of anaesthesia impacted on the risk of RAE occurring. In this observational study, intravenous (i.v.) induction with propofol was associated with a significantly lower incidence of RAE compared with inhalational induction with sevoflurane, particularly with regard to the occurrence of laryngospasm (RR 3.2[2.6-4] p less than 0.0001). However, worldwide inhalational induction of anaesthesia is the most common way of anaesthesia induction in children because it avoids a needle prick in the awake child.
The aim of this study is to randomise 300 infants and children (0-8 years) with a high risk for respiratory complications, who are undergoing minor elective surgery, to receive either an i.v. induction with propofol or an inhalational induction with sevoflurane. All patients will be monitored for the occurrence of RAE in the perioperative period.

We hypothesize that patients receiving i.v. propofol will demonstrate less respiratory complications (laryngospasm, bronchospasm, desaturation less than 95%, airway obstruction, severe coughing and/or postoperative stridor compared with patients receiving sevoflurane (22% as compared to 38%). These values are based on our previous large cohort study.
Trial website
Trial related presentations / publications
Papers are currently being drafted. Once published this section will be updated.
Public notes

Contacts
Principal investigator
Name 30930 0
Prof Britta Regli-von Ungern
Address 30930 0
Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
SUBIACO,
WA 6008
Country 30930 0
Australia
Phone 30930 0
+61893408109
Fax 30930 0
Email 30930 0
britta.regli-vonungern@health.wa.gov.au
Contact person for public queries
Name 14177 0
Prof Britta Regli-von Ungern
Address 14177 0
Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
SUBIACO,
WA 6008
Country 14177 0
Australia
Phone 14177 0
+61893408109
Fax 14177 0
Email 14177 0
britta.regli-vonungern@health.wa.gov.au
Contact person for scientific queries
Name 5105 0
Prof Britta Regli-von Ungern
Address 5105 0
Princess Margaret Hospital for Children
Department of Anaesthesia and Pain Management
Roberts Road
SUBIACO,
WA 6008
Country 5105 0
Australia
Phone 5105 0
+61893408109
Fax 5105 0
Email 5105 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