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Timing of laryngeal mask removal in children with a high risk for postoperative respiratory complications –awake or anesthetized?

A randomised controlled trial to assess respiratory complications following removal of a laryngeal mask (awake vs. anaesthetised) in children undergoing adeno-/tonsillectomy with a high risk of postoperative respiratory complications

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000387224
Enrollment
290
Registered
2009-05-29
Start date
2009-07-06
Completion date
2014-01-28
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

Removal of the laryngeal mask airway can be performed while children are still deeply anesthetized or when they are awake (as defined by eye opening, grimacing, coughing, and purposeful movements). Each technique has its own advantages and disadvantages. In healthy children, it has been shown that there are no clinical differences between removal of the laryngeal mask airway in the awake state vs anesthetized state. In patients with a high risk of developing a postoperative respiratory problems (e.g. coughing) such as those with asthma, it may be preferable to remove the laryngeal mask airway while the patients are still anesthetized to avoid airway stimulation and consecutively bucking, coughing and bronchospasm. The results of a recent large prospective cohort study at our institution with over 9000 children allow to identify children with a high risk for developping postoperative respiratory complications. The aim of this present randomized controlled trial is to assess whether children at a high risk for respiratory problems benefit from anethetized removal of the laryngeal mask airway as compared to awake removal of the laryngeal mask airway following adenoidectomy. We hypothesize that children with a high risk for respiratory problems defined by the presence of either airway susceptibility, eczema or a positive family history who have their laryngeal mask airway removed deeply anaesthetised will demonstrate less respiratory problems compared with high risk children who have it removed awake.

Interventions

Group “awake” The children of group “awake” will have their laryngeal mask airway (LMA) removed awake. The LMA will be removed when the children have demonstrated facial grimace, adequate tidal volume and respiratory rate, coughing with open mouths or opening of their eyes and purposeful movements.

Sponsors

Britta 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 16 Years
Healthy volunteers
No

Inclusion criteria

Children, aged 0 to 16 years, male or female undergoing elective adenoidectomy or adenotonsillectomies with or without grommets insertion with one or more of the following risk factors (I-III) with the plan to use a laryngeal mask airway (as assessed by an anaesthetist independent of the study team): I. Airway susceptibility as defined as 1 or more of the following a. Cold or flu in the last two weeks b. Wheezing > 3 times in the last 12 months c. Wheezing at exercise d. Nocturnal dry cough II. Current or past eczema III. Positive family history as defined as 1 or more of the following a. =2 family members with asthma b. =2 family members with eczema c. =2 family members with hayfever d. Only mother smoking or mother and father smoking

Exclusion criteria

Known cardiac disease, airway or thoracic malformations, need for premedication with midazolam.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 22, 2026