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Trial registered on ANZCTR


Registration number
ACTRN12611001101976
Ethics application status
Approved
Date submitted
5/12/2010
Date registered
24/10/2011
Date last updated
24/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of The Laryngeal Mask Airway Unique for Adenotonsillectomy
Scientific title
We will to compare the safety between the disposable unique laryngeal mask airway and the tracheal tube for adenotonsillectomy in paediatric patients
Secondary ID [1] 273210 0
Nil
Universal Trial Number (UTN)
U1111-1118-4244
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laryngospasm during the surgery and at the recovery room 258769 0
Hypoxia before, during and after anaesthesia 258770 0
Bronchospasm during the surgey and at the recovery room 258771 0
Gastric contents regurgitation 258772 0
Condition category
Condition code
Anaesthesiology 258915 258915 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients will be randomised by sealed envelopes. After premedication with oral midazolam the children will be monitored with EKG, peripheral oxygen saturation, non invasive blood pressure. The anesthetic induction will be inhalatory with sevoflurane plus O2/N2O (50%) in a Jackson Rees device and hydratation with Ringer's solution. After propofol 1.5mg.kg and fentanyl 2.0mcg.kg, according the randomization we will to use the disposable Unique LMA, choosing the size and insertion techinique according the manufactor's indication or a laryngoscopie with Miller's blade and a paedicatric cuffed tracheal tube, proper to child size . The surgeon will to use the Mc Ivory device to open the mouth and at the end of the surgical procedure, we will perform a tracheoscopy with a apropriated size flexibe fiberscope, to look for blood or secretions. We will analyse the oxygen level at the follow times: 1-after remove the facial mask, 2-after the insertion of the respiratory device (LMA or tracheal tube), 3-after the patient positioning (neck hyperextension), 4- after remove the respiratory device, 5-at admitssion in the recovery room. We will register the occurence of: respiratory adverse events like hypoxia (definied as oxygen saturation bellow 92%), laryngospasm, bronchospasm, cough, and stridor. After 24 hours, by a phone call, we will ask about nausea, vomits and sore throat. The duration of this study will be about 6 hours at the hospital.
Intervention code [1] 257707 0
Treatment: Devices
Intervention code [2] 269326 0
Other interventions
Comparator / control treatment
The tracheal intubation is the gold standard method for anaesthesia in adenotonsillectomies. Our aim is to compare the safety and the surgical conditions, (visual field, because the LMA cuff can obstruct the surgeons view) of the LMA and the tracheal tube
Control group
Active

Outcomes
Primary outcome [1] 259777 0
Laringospasm: Clinical aspects of respiratory movements (thorax and abdominal), respiratory sounds, stethoscopic sounds, pulse oximetry value
Timepoint [1] 259777 0
1-Induction of anaesthesia
2-After insertion of the respiratory device
3-Positioning the patient for the surgery
4-After take off the respiratory device
5-At the recovery room
Primary outcome [2] 259778 0
Bronchospasm: respiratory sounds at stethoscopic, capnography curve aspect, pulse oximetry value
Timepoint [2] 259778 0
1-Indution of anaesthesia
2 After introdution of the respiratory device (LMA or tracheal tube)
3- At oppening the mouth
4- After removal LMA or TT
5- Recovery room
Primary outcome [3] 262347 0
Cough and stridor: observational aspect of respiratory sounds, oximetry pulse level, respiratory movements (paradoxal movements)
Timepoint [3] 262347 0
After removal the respiratory device and at recovery room admition
Secondary outcome [1] 273886 0
Difficulties on surgical field: if the LMA can obstruct the vision of the surgeon, by asking him
Timepoint [1] 273886 0
During tonsils removal

Eligibility
Key inclusion criteria
Candidates for adenotonsillectomies, aged 1-12.
Minimum age
1 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Airway active infecction, infection at the tonsils, gastric-oesophageal reflux, signals or history of difficult airway management, coagulation abnormalities.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a SigmaStart for Windows (Microsoft Corporation - USA)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Safety - repiratory conditions, looking for falls in oxygen levels, and respiratory events like bronchospasm.
Efficacy - surgical field, the visual conditons for the surgeon
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 3075 0
Brazil
State/province [1] 3075 0
Santa catarina

Funding & Sponsors
Funding source category [1] 258174 0
Hospital
Name [1] 258174 0
Hospital do Coracao de Balneario Camboriu
Country [1] 258174 0
Brazil
Primary sponsor type
Other Collaborative groups
Name
Unimed litoral
Address
Av. Marcos Konder, 1233
Itajai, Santa Catarina
CEP: 88301303
Country
Brazil
Secondary sponsor category [1] 264118 0
Charities/Societies/Foundations
Name [1] 264118 0
Institutie for Anaesthesia Progress (IPA)
Address [1] 264118 0
Av. Marcos Konder, 1111
Itajai - Santa Catarina - Brazil
CEP 88301303
Country [1] 264118 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269151 0
CEP-CONEP Univali
Ethics committee address [1] 269151 0
Ethics committee country [1] 269151 0
Brazil
Date submitted for ethics approval [1] 269151 0
15/07/2010
Approval date [1] 269151 0
29/10/2010
Ethics approval number [1] 269151 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31989 0
Address 31989 0
Country 31989 0
Phone 31989 0
Fax 31989 0
Email 31989 0
Contact person for public queries
Name 15236 0
Dante Ranieri Junior
Address 15236 0
XV Novembro, 222 apartment 10 (street)
ZIP 88301420
Itajai
Santa Catarina
Country 15236 0
Brazil
Phone 15236 0
+55-47-33492176
Fax 15236 0
+55-47-33492176
Email 15236 0
deranieri@terra.com.br
Contact person for scientific queries
Name 6164 0
Dante Ranieri Junior
Address 6164 0
XV Novembro,222 ap 10
Itajai - SC - Brazil
ZIP 88301420
Country 6164 0
Brazil
Phone 6164 0
Tel: +55-47-33463766
Fax 6164 0
+55-47-33463766
Email 6164 0
sanit@brturbo.com.br

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
No additional documents have been identified.