Safer anaesthesia for children with asthma (SAFA trial): Can exhaled nitric oxide (NO) levels predict children at risk for respiratory complications? – a pilot study

Not Applicable

Completed

• Conditions: This study aims to assess the usefulness of expiratory nitric oxide (eNO) to detect children with a high risk for perioperative respiratory adverse events; Anaesthesiology - Anaesthetics; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12612000608864
• Lead Sponsor: Department of Anaesthesia and Pain Management

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Children, aged 4 to 16 years, male or female undergoing elective minor surgery
100 healthy children with no risk factors
180 children with 2 or more risk factors for developing PRAE:
-cold or flu currently or in the last 2 weeks
-eczema at present or in the past
-wheezing in the last 12 months
-asthma in the past (if wheezing in the last 12 months is negative)
-dry nocturnal cough
-wheezing at exercise
-family history of asthma (mother, father and/or siblings)
-family history of eczema (mother, father and/or siblings)
-family history of hay fever (mother, father and/or siblings)
-passive smoking (mother, father, caregiver)

Exclusion Criteria

Children with airway malformations
Pre-medication of Midazolam
Children with Neurological imparement
Children with Cardiac Disease
Children who are uncooperative

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint will be the total of respiratory complications which will be assessed via clinical assessments[The respiratory complications will be assessed in the entire perioperative period until the patient is discharged from the post anaesthesia care unit.]

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will be the occurrence and frequency of the individual respiratory complications in in the perioperative period. <br>Presence of respiratory complications is defined by the presence of one or more of the following:<br>-Bronchospasm<br>-Laryngospasm,<br>-Severe coughing<br>-Desaturation < 95%<br>-Airway obstruction <br>-stridor<br><br>The outcomes will be assessed via clinical assessment.[The respiratory complications will be assessed in the entire perioperative period until the patient is discharged from the post anaesthesia care unit.]