Feasibility and efficacy of using lung measurements to predict complications during surgery for young children with and without asthma.

Not Applicable

Completed

• Conditions: Asthmatics having general anaesthesia; Anaesthesiology - Anaesthetics; Respiratory - Asthma; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12617000271303
• 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: 2017-02-22
• Study Completion: 2021-12-16
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Children, aged 4 to 10 years of age, male and female, undergoing elective surgery under general anaesthesia at our site.
Test group:
1 or more respiratory risk factors:
*Wheeze (more than or equal to 3 times) over past year
*Recurrent respiratory symptoms during exercise in the past year
*Persistent dry cough in last 12 months

Control group:
*No doctor diagnosed active respiratory symptoms as listed in test group
*Can have family history of:
*Hay fever
*Asthma
*Eczema

Exclusion Criteria

*Cystic Fibrosis, bronchiectasis (doctor diagnosed conditions)
*Cardiac or Thoracic surgery
*Doctor diagnosed cardiac diseases
*Known major Syndromes
*Use of ketamine or midazolam premedication
*Contraindication to the use of sevoflurane
*Less than 32 weeks gestational age
*Recent cold

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of using a simple and objective screening approach to identify children at an increased risk of perioperative respiratory adverse events (PRAE) prior to surgery by quantification of airway inflammation and assessment of respiratory mechanics. Feasability will be assessed by the rate of patients who can successfully complete the measurements on the day of surgery.<br>[Measurements completed prior to anaesthesia induction on the ward. Perioperative respiratory adverse events (PRAE) will be assessed throughout anaesthesia by anaesthetists (induction, maintenance, emergence, recovery phases) and in recovery ward after surgery by nurses.]

Secondary Outcome Measures

Name	Time	Method
The effect size of the incidence of perioperative respiratory adverse events (PRAE) between children with active respiratory symptoms such as asthma, wheeze and persistent dry nocturnal cough and children with no risk factors (controls). PRAE are assessed by anaesthetist during procedure and by post anaesthesia care unit (PACU) nurse in the recovery unit after the procedure. Events are documented in real time.[perioperative respiratory adverse events (PRAE) will be assessed throughout anaesthesia (induction, maintenance, emergence, recovery phases) and in recovery ward after surgery.]