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Randomised controlled trial: Respiratory complications in infants undergoing general anaesthesia with a laryngeal mask airway versus an endotracheal tube

Randomised controlled trial: Respiratory complications in infants undergoing general anaesthesia with a laryngeal mask airway versus an endotracheal tube

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000250033
Enrollment
181
Registered
2010-03-24
Start date
2010-07-08
Completion date
2015-05-07
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Infants undergoing minor elective surgery have their airway managed at the discretion of the anaesthetist in charge with either an endotracheal tube or an laryngeal mask airway. Research already done witin the Princess Margaret Hospital for Children (PMH) Anaesthetic Unit has identified some patients with asthma, eczema, hay fever, a current cold & exposure to smoking have a higher risk of airway complications following their surgery. However, the best practice for the management of an infant's airway is still under debate. The aim of this study is to identify which airway support, laryngeal mask or endotracheal tube, is safer in regards to respiratory problems in the perioperative period for infants (0-12 months) undergoing minor general surgery.

Interventions

Endotracheal intubation for airway maintenance for elective surgical procedure following induction of anaesthesia. The procedure is a one off intervention with the endotracheal tube staying in place for the total duration of the procedure which ranges from approx. 30 min to 2 hours.

Sponsors

Britta Regli-von Ungern-Sternberg
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
0 to 12 Months
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 11, 2026