ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000387224

Ethics application status

Approved

Date submitted

12/05/2009

Date registered

29/05/2009

Date last updated

12/01/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

respiratory complications in paediatric anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Other interventions

Comparator / control treatment

Group “anesthetised”
The children of the group “anaesthetised” will have their LMA removed during the surgical stage of general anaesthesia when the end-tidal sevoflurane level is greater than 1 minimum alveolar concentration (MAC). Sevoflurane is administered via an anaesthetic vaporiser. At induction of anaesthesia it is slowly increased to a dose of greater than one MAC and then left constant throughout surgery.

Control group

Active

Outcomes

Primary outcome [1]

Primary endpoint will be the total of respiratory complications in the perioperative period.
Presence of perioperative respiratory complication as defined one or more of the following:
Bronchospasm, laryngospasm, severe coughing, desaturation < 95%, airway obstruction and/or stridor.
Laryngospasm is defined as a complete airway obstruction associated with muscle rigidity of the abdominal and chest walls. Bronchospasm is defined as the occurrence of an increased respiratory effort, especially during expiration, and wheeze on auscultation. Airway obstruction is defined as the presence of partial airway obstruction in combination with a snoring noise and respiratory efforts. Assessement via clinical examination and observation.

Timepoint [1]

Respiratory complications will be monitored continuously in the perioperative period

Secondary outcome [1]

presence of individual respiratory complication (laryngospasm, bronchospasm, desaturation, severe coughing, airway obstruction stridor) Details see above under primary outcome Assessement via clinical examination and observation.

Timepoint [1]

Respiratory complications will be monitored continuously in the perioperative period

Eligibility

Key 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

Minimum age

No limit

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Inclusion and exclusion criteria will be checked at the preanaesthetic assessment. Written consent consisting of parental permission and also child assent when applicable, will be obtained. The person determining if a child is eligible for inclusion in the trial is unaware when the decision is made to which group the child would be allocated. Following inclusion into the study protocol, the children will be randomly assigned to group “awake” or group “anesthetised” by computer generated block randomisation. Allocation will be concealed in sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The patients will be randomised by computer generated block randomisation. Following written informed consent, the participant will be assigned the next available Participant Number. The Participant Number will correspond to a numbered randomisation envelope. The randomisation is concealed in the closed envelope and will only be opened by the anaesthetist in charge of the patient at induction of anaesthesia. The participant number will be used to identify the patient for the duration of the study.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/06/2009

Actual

6/07/2009

Date of last participant enrolment

Anticipated

31/03/2014

Actual

28/01/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

290

Accrual to date

Final

290

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Princess Margaret Hospital for Children Department of Anaesthesia

Address [1]

Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Princess Margaret Hospital Foundation

Address [2]

68 Hay street
Subiaco
WA 6008

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

NHMRC

Address [3]

National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601

Country [3]

Australia

Primary sponsor type

Individual

Name

Britta von Ungern-Sternberg

Address

Department of Anaesthesia
Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Mairead Heaney

Address [1]

Department of Anaesthesia
Princess Margaret Hospital for Children Roberts Road SUBIACO, WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee Princess Margaret Hospital

Ethics committee address [1]

Roberts Road
Subiaco, WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/05/2009

Ethics approval number [1]

1645/EP

Summary

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.

Trial website

Trial related presentations / publications

None yet.

Public notes

Contacts

Principal investigator

Name

Prof Britta Regli-von Ungern-Sternberg

Address

Department of Anaesthesia and pain management
Princess Margaret Hospital for Children
Roberts Road
Subiaco
WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

Contact person for public queries

Name

Britta von Ungern-Sternberg

Address

Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

Contact person for scientific queries

Name

Britta von Ungern-Sternberg

Address

Princess Margaret Hospital for Children
Department of Anaesthesia
Roberts Road
Subiaco, WA 6008

Country

Australia

Phone

+61893408109

Fax

britta.regli-vonungern@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Deep or awake removal of laryngeal mask airway in children at risk of respiratory adverse events undergoing tonsillectomy-a randomised controlled trial.	2018	https://dx.doi.org/10.1016/j.bja.2017.11.094

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically