ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12614000424606

Ethics application status

Approved

Date submitted

3/04/2014

Date registered

17/04/2014

Date last updated

30/01/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Obesity: Alterations in lung mechanics - impact on the incidence of perioperative respiratory adverse events (OPRAE)

Scientific title

In children receiving a general anaesthetic will obese or overweight children have differences in the incidence of perioperative respiratory adverse events and have alterations in lung mechanics compared to normal weight children?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

OPRAE

Linked study record

Health condition

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

The impact of obesity on the incidence of perioperative respiratory adverse events and the alterations in lung mechanics compared to normal weight children.

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Normal development and function of the respiratory system

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

All participants will be recruited at the preanaesthetic visit and will be consented voluntarily to the study after approval from the consulting anaesthetist.
Children’s weight, height and age will be used to calculate their BMI percentile to assign them to the two study groups:
*Group 1, normal weight: patients aged between 6 and 16 years with a BMI above the 5th percentile and below the 85th percentile
*Group 2, overweight/obese: patients aged between 6 and 16 years with a BMI greater than or equal to the 85th percentile.
Each patient will complete Lung function testing which will involve two different tests before anaesthesia induction: the measurement of respiratory mechanics using the forced oscillation technique and lung volumes using the multiple breath washout technique. The forced oscilation technique will be repeated after anaesthesia induction. Patients will be monitored throughout their procedures and postoperatively in the post anaesthesia care unit (PACU). Any respiratory complications that may occur will be documented. Patients will be followed up on the ward or via telephone within 3 days following surgery incase of any complications.

Intervention code [1]

Not applicable

Comparator / control treatment

The obese/overweight children will be compared to the normal weight children as defined by the BMI percentile:
*Group 1, normal weight – patients aged between 6 and 16 years with a BMI above 5th percentile and below 85th percentile
*Group 2, overweight/obese – patients aged between 6 and 16 years with a BMI greater than or equal to the 85th percentile.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is to assess the incidence of Perioperative Respiratory Adverse Events between children who are overweight/obese and children who have a normal weight.
These respiratory adverse events include laryngospasm, bronchospasm, desaturation <95%, airway obstruction, severe coughing and/or postoperative stridor as assessed by the treating anaesthetist and in recovery by the treating nurses.

Timepoint [1]

The Respiratory adverse events will be recorded at anaesthesia induction, maintenance, emergence and in recovery.

Secondary outcome [1]

The secondary outcome is to compare the effects of postural changes in lung volumes and respiratory mechanics between children who are overweight/obese and children who have a normal weight.

Timepoint [1]

These outcomes will be measured using the forced ocsilation technique prior to and after anaesthesia induction and by using the multiple breath washout technique prior to anaesthesia induction.

Eligibility

Key inclusion criteria

*Children undergoing elective surgery
*Male or Female aged between 6 and 16 years
*Children with a BMI more than the 5th and less than the 85th percentile (normal weight group)
*Children with a BMI more than or equal to 85th percentile (overweight and obese group)
*Children having a laryngeal mask airway (LMA).

Minimum age

6 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

*Children with a known cardiopulmonary disease:
*Uncorrected congenital heart disease
*Primary/secondary pulmonary hypertension
*Cardiac/thoracic malformations/tumours
*Structural lung changes
*Airway malformations, thorax deformity
*Children unable to perform the lung function tests.
*Children receiving a sedating premedication (e.g. midazolam, clonidine) before surgery.
*Children having used a bronchodilator within 5 hours prior to surgery.
*Children having an endotracheal tube inserted during anaesthesia
The above list is not an exhaustive list. Other less common cardiopulmonary conditions will be assessed by the anaesthetist in charge in consulation with the study team.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

To detect the effect size in this study, we will need 44 obese/overweight children and 44 normal weight children to have a statistical power of 0.8 at the significance of 0.05. The sample size and power were estimated in STATA environment. Furthermore, based on our research experience protocol violations, poor quality data and patient withdrawals are common factors that have a significant influence on the sample size of a study. These need to be included in the final sample size calculation in order to obtain 44 usable datasets per group. We estimate these factors to account for approximately 25% of each cohort, thus leading to a sample size of 110 children divided into 2 groups of 55.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/04/2014

Actual

25/11/2014

Date of last participant enrolment

Anticipated

30/12/2016

Actual

10/01/2017

Date of last data collection

Anticipated

Actual

10/01/2017

Sample size

Target

110

Accrual to date

Final

110

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Princess Margaret Hospital Foundation

Address [1]

Level 1,
68 Hay Street
Subiaco
WA 6008

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Australia and New Zealand College of Anaesthetists

Address [2]

ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia.

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

NHMRC

Address [3]

National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601

Country [3]

Australia

Primary sponsor type

Individual

Name

Britta Regli Von Ungern Sternberg

Address

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

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children Ethics Committee

Ethics committee address [1]

Level 1, Children's Clinical Research Facility
Princess Margaret Hospital
Roberts Road, Subiaco  
Perth 
WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/10/2013

Approval date [1]

16/04/2014

Ethics approval number [1]

2013110

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 paediatric anaesthesia, obesity is a significant problem with obese children not only having anaesthesia-relevant co-existing diseases like asthma or hypertension, but also having a higher incidence of anaesthesia related complications. Many factors encountered during general anaesthesia such as supine positioning (lying down, face up), anaesthetic agents and the type of surgery affect the functioning of the respiratory system and in particular lung volumes and respiratory mechanics. These anaesthesia related changes in lung function are expected to be even more pronounced in obese patients. The incidence of obesity is rising steadily in Australia with 25% of children being overweight or obese in 2011-2012 according to the Australian Bureau of Statistics.  
A better knowledge of lung health and the changes in lung function caused by anaesthesia and the impairment of respiratory mechanics by obesity will help improve the management of these high risk patients. 
We therefore aim to assess lung function changes as well as the incidence of PRAE in healthy and overweight/obese children. 
We hypothesise that
1.The incidence of PRAE will be higher in obese/overweight children compared to normal weight children.
2.Obese or overweight children will have a significantly different respiratory resistance (Rrs) and reactance (Xrs) compared to normal weight children. 
3.The state of consciousness (being awake or anaesthetised) and the body position (being seated or supine) will affect the respiratory resistance and reactance and that this effect with be more pronounced in overweight and obese children compared to children with a healthy weight.

We will recruit 110 children between the ages of 6 and 16 that have a BMI between the 5th and 85th percentile for the healthy population (n equal to 55) and more than or equal to the 85th percentile for the obese/overweight population (n equal to 55). Lung function testing consisting of Forced Oscillation Technique (FOT) and Multiple Breath Washout (MBW) will be completed on all patients on the day of their procedure. All patients will be monitored closely during and following their procedures and any respiratory events will be recorded. 

We are hoping to get a better understanding of the lung health of the obese and overweight population of children in order to improve the anaesthetic management of this high risk group.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof 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

[email protected]

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

[email protected]

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

[email protected]

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically