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Trial registered on ANZCTR

Registration number

ACTRN12614001252606

Ethics application status

Approved

Date submitted

14/11/2014

Date registered

2/12/2014

Date last updated

22/04/2020

Date data sharing statement initially provided

12/04/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Development of new evidence-based ventilation guidelines for children undergoing surgery with general anaesthesia

Scientific title

To collect lung function outcomes in children undergoing surgical procedures with a general anaesthetic aged between 1 and 15 years of age and use the data with their demographic information to develop reference ranges and nomograms.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

None

Linked study record

Health condition

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

Mechanical ventilation ranges in children undergoing general anaesthesia for a surgical procedure.

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Respiratory

Normal development and function of the respiratory system

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.
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. These tests will take approximtaley 1 hour. The forced oscilation technique will be repeated after anaesthesia induction. This will take between 5 and 10 minutes. 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

No control. All patients recruited are undergoing a general anaesthetic for a surgical procedure

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome is the measurement of respiratory resistance in mechanically ventilated paediatric population.

Timepoint [1]

Measurements will be completed prior to and after anaesthesia induction by the forced oscilliation technique.

Primary outcome [2]

The primary outcomes are the measurement of pulmonary compliance in mechanically ventilated paediatric population.

Timepoint [2]

Measurements will be recorded by the lung function testing (Multiple Breath Washout) prior to the start of the surgery.

Secondary outcome [1]

Creation of reference ranges for the mechanically ventilated paediatric population.

Timepoint [1]

At the end of the study once data collection is completed all of the data will be analysed and collated to form reference ranges for the paediatric population.

Eligibility

Key inclusion criteria

Male or female
Aged 1 to 15 years
Group 1 children aged between 1 and < 6 years
Group 2 children aged between 6 and < 11 years
Group 3 children aged between 11 and < 16 years
Undergoing surgery with general anaesthesia in Princess Margaret Hospital.

Minimum age

1 Years

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children receiving a sedating premedication (e.g. midazolam, clonidine) before surgery.
Children born <37 completed weeks of gestation or having received respiratory support in the neonatal period
Children with a known difficult airway or thoracic malformation.
Children with a known lung and/or cardiopulmonary disease:
Uncorrected congenital heart disease
Primary/secondary pulmonary hypertension
Cardiac/thoracic malformations/tumours
Structural lung changes
Asthma
Cystic Fibrosis
Recurrent wheeze > 2 months or persistent cough > 3 months in past year

The above list is a non-exhaustive list. Any other less common cardiopulmonary conditions will be assessed by the anaesthetist in charge and accounted for in the exclusion criteria list.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

This study is the first study to establish reference values for lung function and lung mechanics in children under general anaesthesia for surgical procedures. We have thoroughly reviewed the relevant literature and were not able to find reported reference values of resistance and reactance under anaesthesia in children.

The primary aim of the study is to develop reference ranges for respiratory resistance and compliance and tidal breathing measurements in children aged 1-15 years during surgery under general anaesthesia. We acknowledge that lung function increases with growth at a varied rate during different age periods. We will develop the reference equations separately for the three age groups: 1 to<6, 6 to<11 and 11 to <16 years. Age, gender, height, weight and other potential predictors for these lung function parameters will be investigated to develop the reference equations. In the best model to predict the normal values of lung function we expect to include all predictors with a correlation coefficient >0.3 for a given lung function parameter. At the significance of 0.05 we have a power of 86% to significantly identify predictors with this strength of correlation for 100 children in each of the three age groups. There will be confounding effects between predictors. We select a variance inflation factor of 1.2 for the adjustment of multicollinearity. After the adjustment we need to recruit 120 children for each of the three age groups. We have further to account for 25% loss due to unacceptable data, subject exclusion due to clinical conditions during surgery and/or change in clinical management of airway over the three age groups. Therefore we will recruit 480 children overall for the study to develop reference equations of lung function parameters in children for the three age groups.

For the investigated predictors we will perform a set of regression analyses with respiratory resistance and compliance and tidal breathing measurements as dependent variables. Diagnostic tests for outliers and influential cases will be utilised to identify outliers. Linear, logarithmic, power and exponential regression techniques will be employed to determine the best relationship between every measured lung function parameter and the investigated predictors. The best-fitting regression model will be selected according to the likelihood ratio test.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

The investigator team thought we may have sufficient participant numbers.

Date of first participant enrolment

Anticipated

15/12/2014

Actual

26/03/2015

Date of last participant enrolment

Anticipated

31/05/2019

Actual

22/08/2017

Date of last data collection

Anticipated

Actual

23/08/2017

Sample size

Target

480

Accrual to date

Final

418

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]

Hospital

Name [1]

Princess Margaret Hospital

Address [1]

Roberts Road
Subiaco
WA 6008

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof 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]

Charities/Societies/Foundations

Name [1]

Australian and New Zealand College of Anaesthetists,

Address [1]

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

Country [1]

Australia

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]

02/06/2014

Approval date [1]

06/11/2014

Ethics approval number [1]

EP 2014064

Summary

Brief summary

Paediatric patients undergoing elective or emergency surgery, or who have been admitted to the Neonatal/Paediatric Intensive Care Unit (NICU/PICU), often require mechanical ventilation. During the perioperative period, these patients are at risk of several types of lung injury, including atelectasis (collapse of lung tissue), pneumonia (disease marked by inflammation of the lungs), pneumothorax (presence of air within the pleural cavity leading to lung collapse), Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
Anaesthetic management can contribute to these injuries, exacerbate any underlying lung conditions or even improve outcomes, depending on the specific situation. Moreover, several studies have shown that pulmonary complications, more specifically respiratory failure requiring ventilation, are associated with high morbidity and mortality along with increased health-related costs and greater length of hospital stay. 
Ventilation mode (volume, pressure or dual), modality (controlled, assisted, support ventilation) and respiratory parameters (e.g. tidal volume and respiratory rate) are the most important factors of mechanical ventilation. An important aspect of ventilation strategies is to optimise respiratory mechanics. A critical part of this process is knowing the normal range of respiratory mechanics during ventilation. This allows clinicians to define ventilation such that the respiratory mechanics can be maintained at a level expected for that particular patient and therefore protect against over- or under ventilation and thus minimise potential harm. While the normal ranges of a variety of respiratory outcomes during mechanical ventilation have been assessed in adults, there are no normal reference ranges of values available for the paediatric population. This precludes the formulation of clear evidence-based ventilation guidelines in children. 
Measurable mechanical and physiological parameters such as pulmonary compliance (ease of expansion of the lungs and thorax), respiratory resistance (resistance to flow of gases during ventilation), tidal volume (volume of air moved in and out during quiet/normal breathing) can be used to effectively monitor the effect of changes in mechanical ventilation and limit the risk of Ventilator-Induced Lung Injury VILI. Furthermore, the lack of precise data on these essential parameters as well as the implications relating to the lack of this important data, have been highlighted by experts from the recent American Thoracic Society workshop on the evaluation of respiratory mechanics and function in patients being cared for in paediatric and neonatal ICU settings (personal communication from Dr Carmichael-Peterson, Chair of the American Thoracic Society Task Force for the measurement of respiratory function in the ICU). Better ventilation strategies are also of particular importance in children with cardiac and/or respiratory co-morbidities undergoing anaesthesia as well as children with prolonged surgeries impacting on respiratory function, e.g. pneumoperitoneum, extensive abdominal surgery.

This study aims at measuring lung function outcomes in children aged between 1 and 15 years old who are undergoing surgery under general anaesthesia and require mechanical ventilation. 

We hypothesise that by measuring the respiratory resistance and pulmonary compliance of children undergoing surgery before and after anaesthesia induction, we will be able to develop robust prediction equations and nomograms that define the values of physiological parameters to be programmed in mechanical ventilators for optimal lung function in anaesthetised children having surgery.

Trial website

None

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]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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.

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