None listed
Conditions
Brief summary
Perioperative respiratory adverse events (PRAE) pose a significant risk in paediatric anaesthesia, with the incidence of PRAE being reported between 15 and 50 %. Accurate detection of those at risk for developing PRAE is vital to enable tailoring of their perioperative management. Traditionally, risk of PRAE is assessed using the patient’s past medical history, family medical history and physical examination. However, given the multifactorial nature of the risk of PRAE and children with complex medical backgrounds such as chronic lung disease, obstructive sleep apnoea or obesity, patients may benefit from additional objective preoperative pulmonary function tests. Recently our group published an educational review identifying the clinical utility of preoperative pulmonary function testing in paediatrics which identified that there is little evidence to support the routine use of lung function in preoperative assessment. However, we noted that the measurement of Peak Cough Flow (PCF) is predictive of the need for respiratory support or cough support following surgery suggesting that a higher PCF may reduce the incidence of PRAE; thus far there is no evidence in the role of PCF in preoperative assessment, however this simple, non-invasive and portable test may help identify high-risk subjects. We propose a prospective cross-sectional interventional study to assess if Peak Cough Flow and spirometry in children with and without respiratory symptoms aged 5-10 years is clinically associated with an increased risk of developing PRAE. Monitoring and recording of PRAE (laryngospasm – closure of the vocal cords, bronchospasm – narrowing of the airways, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor-squeaky noises when breathing) will occur throughout the procedure and in the post anaesthesia care unit (PACU). We hypothesise that children with a higher percent of predicted PCF will be at a reduced risk for developing PRAE.
Interventions
All participants will be recruited on the day of surgery, once informed consent and assent is gained by the research team member (research officers, research assistants) the participant’s height and weight will be measured, if a participant is unable to stand an ulna length measurement will be used to estimate standing height. The participant will perform baseline peak cough flow (PCF) and Spirometry as per international guidelines and Perth Children’s Hospital (PCH) respiratory laboratory proce
All participants will be recruited on the day of surgery, once informed consent and assent is gained by the research team member (research officers, research assistants) the participant’s height and weight will be measured, if a participant is unable to stand an ulna length measurement will be used to estimate standing height. The participant will perform baseline peak cough flow (PCF) and Spirometry as per international guidelines and Perth Children’s Hospital (PCH) respiratory laboratory procedures. The order of tests will be randomised to prevent possible fatigue concerns. Parentally reported respiratory history and medication use will be recorded. The tests will be completed by trained research team members and are expected to take 20-30 minutes in total. The testing will occur on the day of surgery prior to the patient being brought to theatre. Peak Cough Flow • The participant will be sitting, preferably with feet on the floor, if this is not possible the participant will sit as upright as possible, and any change in position will be recorded. • The participant will place a filtered mouthpiece between their teeth and seal lips tightly, the research staff member will instruct them to take a full inspiration and then perform a single fast cough as hard as possible. • Measurements will be repeated until at least 3 acceptable measurements are performed that are within 0.67L/s of each other. A maximum of 8 trials will be performed. • Reported variables with be PCF (L/s), the absolute value and the percent predicted value will be reported. Spirometry • Spirometry will be performed to the international standards. At least 3 technically acceptable measurements will be performed with the best FEV1 and FVC measurements being within 0.15L of each other. A maximum of 8 trials will be performed. • 3 acceptable and repeatable inspiratory measurements will also be recorded as per international guidelines. Inspiratory loop shape will be assessed by 2 experienced research staff members (CO, MO) to identify any abnormalities of the flow value loop shape. • Reported variables will be absolute and z score values for FEV1, FVC, FEV1/FVC, FIF50/FEF50. The shape of the flow volume loops will be consensus scored with a binary normal/abnormal scoring.
Sponsors
Perth Children's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
Children undergoing elective surgery under general anaesthetic • Male or female aged between 5 and 10 years • Control group: Children without respiratory symptoms defined as below • Respiratory Symptoms group: Children with respiratory symptoms including: o Recent Upper respiratory Tract infection (<2wks) o Nocturnal cough o >2 bouts of wheeze in the previous 12 months o Current doctor diagnosis of asthma o Wheeze or cough on exertion in the previous 3 months.
Exclusion criteria
Children receiving midazolam as a premedication before surgery Children who have not performed the PCF measurement prior to receiving a premedication of clonidine or dexmedetomidine Children with a known difficult airway. Children with a known significant cardiac disease: o Uncorrected congenital heart disease o Primary pulmonary hypertension o Cardiac malformations/tumours Inability to perform the required manoeuvre History of syncope related to forced expiration/cough Haemoptysis of unknown origin; the sniff nasal inspiratory pressures and peak cough flow manoeuvres may aggravate the underlying condition Pneumothorax. Less than 1 week since successful treatment Unstable cardiovascular status, recent myocardial infarction, or pulmonary embolism; Thoracic, abdominal, or cerebral aneurysms Recent eye surgery within 1 week Sinus or middle ear surgery or infection post 1 week Thoracic or abdominal surgical procedures within 4 weeks. Non English-speaking families
Outcome results
None listed