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

Not Applicable

• Conditions: Mechanical ventilation ranges in children undergoing general anaesthesia for a surgical procedure.; Anaesthesiology - Other anaesthesiology; Respiratory - Normal development and function of the respiratory system

• Registration Number: ACTRN12614001252606
• Lead Sponsor: Prof Britta Regli-von Ungern-Sternberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-02
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 480

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the measurement of respiratory resistance in mechanically ventilated paediatric population. [Measurements will be completed prior to and after anaesthesia induction by the forced oscilliation technique.];The primary outcomes are the measurement of pulmonary compliance in mechanically ventilated paediatric population. [Measurements will be recorded by the lung function testing (Multiple Breath Washout) prior to the start of the surgery.]

Secondary Outcome Measures

Name	Time	Method
Creation of reference ranges for the mechanically ventilated paediatric population. [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.]