Randomised controlled trial: Respiratory complications in infants undergoing general anaesthesia with a laryngeal mask airway versus an endotracheal tube
Not Applicable
- Conditions
- Respiratory complications in children receiving either a laryngeal mask airway or an endotracheal tubeAnaesthesiology - Anaesthetics
- Registration Number
- ACTRN12610000250033
- Lead Sponsor
- Britta Regli-von Ungern-Sternberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 290
Inclusion Criteria
Children, aged 0 to 12 months, male or female undergoing combined general and regional (e.g. caudal, penile block) anaesthesia with the plan to use either a laryngeal mask airway or endotracheal tube (as assessed by an anaesthetist independent of the study team).
Exclusion Criteria
Known cardiac disease, airway or thoracic malformations, need for premedication with midazolam, contraindication of laryngeal mask airway or endotracheal tube use as assessed by an anaesthetist independent of the study team.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method total of respiratory complications. <br>Presence of perioperative respiratory complication as defined by one or more of the following:<br>Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.<br>The presence/absence of respiratory complications will be recorded during the time of anaesthesia and the time spent in recovery. The overall presence of respiratory complications will be taken for the analysis[during the time of anaesthesia and the time spent in recovery.]
- Secondary Outcome Measures
Name Time Method occurrence and frequency of the individual respiratory complications in both intra-operatively and in the recovery area.<br>THe outcome will be assessed by clinical monitoring.[during the time of anaesthesia and the time spent in recovery.]