Perioperative complication following anaesthesia in children with respiratory infection (RHUBARBE)

26/11/2016
30/03/2024
EU PAS number:
EUPAS16436
Study
Finalised
Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Respiratory symptom
Population studied

Short description of the study population

Children aged ≥ 1 month anaesthesized while presenting active or past respiratory infections.
Children ≥ 1 month of age with ASA I to IV, and any surgery were included.

Age groups

  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)

Special population of interest

Other

Special population of interest, other

Respiratory infection patients

Estimated number of subjects

1000
Study design details

Main study objective

Determining major respiratory complications during anaesthesia in children with respiratory tract infection

Outcomes

The incidence and prevalence of major respiratory and general complications during anaesthesia in children with respiratory tract infection, -The risk foactor of major respiratory and general complications during anaesthesia in children with respiratory tract infection- Factors leading to delayed or not naesthesia during anaesthesia in children with respiratory trat infection

Data analysis plan

Descriptive statistics (mean, sd, median, ranges, N, %)Multivariate analysis : logistic regression and/or Tree analysis