Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000208909
Ethics application status
Approved
Date submitted
23/02/2011
Date registered
24/02/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of endotracheal lidocaine instillation in reducing increases of intracranial pressure during endotracheal suctioning procedures
Scientific title
Use of Endotracheal Lidocaine in Reducing Increases in Intracranial Pressure During Endotracheal Suctioning in Severe Traumatic Brain Injury Children: A randomized, controlled, double-blind, crossover study
Secondary ID [1] 259659 0
not applicable
Universal Trial Number (UTN)
U1111-1119-5415
Trial acronym
not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe traumatic brain injury 261223 0
intracranial hypertension 261224 0
endotracheal intubation 261225 0
Condition category
Condition code
Neurological 259371 259371 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 2% lidocaine
Doses: lidocaine 1.5 mg/kg added to normal saline (total volume of 5 mL)
Mode of administration: endotracheal instillation
Duration: instillation at 1 ml/s rate
Each study will be performed in duplicate, once after endotracheal lidocaine instillation and once after instillation of an equal volume of a normal saline in a double-blind crossover fashion. Lidocaine and saline will be instilled at body temperature through a 4-French fine tube advanced into the endotracheal tube within its length, near the carina. Approximately 30-60 secs prior to suctioning procedure, the delivery of FiO2 will be increased to 100% while the ventilator settings will remain unchanged. After endotracheal lidocaine or saline solution instillation a 3 min interval will be allowed prior to the suctioning event which will be performed in a single pass using an closed-system suctioning (with an appropriate diameter of the suction catheter, negative pressure of 80-100 mmHg, and total duration of < 15 secs). Inspired oxygen fraction (FiO2)will remain at 100% for 60 secs following the suctioning event then will be returned to the preprocedural level (baseline). After a 3 hour-washout period the crossover solution will be then administered
Intervention code [1] 258086 0
Treatment: Drugs
Comparator / control treatment
Comparator/control treatment: normal saline solution
Doses: 5 mL
Mode of administration: endotracheal instillation
Duration: instillation at 1 ml/s rate
Control group
Placebo

Outcomes
Primary outcome [1] 262187 0
Mean change in the intracranial pressure (mmHg) from baseline. The intracranial pressure will be continuously monitored by a multiparameter bedside monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [1] 262187 0
at baseline (before endotracheal suctioning procedure), during endotracheal suctioning procedure and, 5 min and 15 min after endotracheal suctioning procedure
Secondary outcome [1] 273289 0
heart rate (beats per minute) will be continuously monitored by a multiparameter bedside monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [1] 273289 0
at baseline (before endotracheal suctioning procedure), during endotracheal suctioning procedure and, 5 min and 15 min after endotracheal suctioning procedure
Secondary outcome [2] 273290 0
Invasive mean arterial pressure (mmHg) will be monitored by a multiparameter monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [2] 273290 0
at baseline (before endotracheal suctioning procedure), during endotracheal suctioning procedure and, 5 min and 15 min after endotracheal suctioning procedure
Secondary outcome [3] 273291 0
partial pressure of end-tidal carbon dioxide (PETCO2) will be monitored by a multiparameter monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [3] 273291 0
at baseline (before endotracheal suctioning procedure), during endotracheal suctioning procedure and, 5 min and 15 min after endotracheal suctioning procedure
Secondary outcome [4] 273292 0
oxygen saturation (%) on pulse oximetry will be continuously monitored by a bedside multiparameter monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [4] 273292 0
at baseline (before endotracheal suctioning procedure), during endotracheal suctioning procedure and, 5 min and 15 min after endotracheal suctioning procedure

Eligibility
Key inclusion criteria
Patients presenting severe closed-head injury presenting the following: a) age younger than 16 years, b) Glasgow Coma Scale score 4-8 and intracranial pressure monitoring, c) hemodynamic status stable and, d) within 72 hours from admission.
Minimum age
1 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intracranial hypertension (intracranial pressure > 20 mmHg), hepatic disease and, patients with acute lung injury (PaO2/FiO2 < 300).

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)
Allocation involved contacting the holder of the allocation schedule (study pharmacist) who was "off-site" (Department of Pharmacy) and had no contact with the study participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a 15% change in intracranial pressure from baseline with an SD of 5 mm Hg and an a risk of 0.05 and a ß risk of 0.2, the size of the study population needed to be at least 13 patients for a cross-over design.
Continuous data are reported as a mean and standard deviation (SD) and analyzed with an unpaired Student’s t-test. To compare the intracranial pressure changes between the two drugs during study period, mean differences with 95% confidence intervals (95% CIs) will be reported. Repeated-measures analysis of variance will be used to test for within-group differences followed with t test with Bonferroni correction..
All analysis will based on the intention-to-treat principle . Calculations will be performed by using the SPSS ( statistical packages (SPSS Inc., Chicago, IL), applying 2-sided Fisher exact tests for comparisons of categorical data, and Mann–Whitney U tests for continuous data. Differences will be considered statistically significant at p < 0.05

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2011
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
13
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 3219 0
Brazil
State/province [1] 3219 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 258549 0
Hospital
Name [1] 258549 0
Hospital do Servidor Publico Municipal
Country [1] 258549 0
Brazil
Primary sponsor type
Individual
Name
Paulo Sergio Lucas da Silva
Address
Pediatric Intensive Care Unit, Department of Pediatrics
Rua Castro Alves, 60
Aclimacao, Sao Paulo
01532-900
Country
Brazil
Secondary sponsor category [1] 257683 0
None
Name [1] 257683 0
Address [1] 257683 0
Country [1] 257683 0
Other collaborator category [1] 251826 0
Individual
Name [1] 251826 0
Simone Brasil Oliveira Iglesias
Address [1] 251826 0
Estrada do Lutero, 1460 - Residencial Paisagem Renoir III - Granja Vianna - Cotia - Sao Paulo
06715-400
Country [1] 251826 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260517 0
Ethics Committee
Ethics committee address [1] 260517 0
Ethics committee country [1] 260517 0
Brazil
Date submitted for ethics approval [1] 260517 0
01/12/2010
Approval date [1] 260517 0
15/02/2011
Ethics approval number [1] 260517 0
219/2010

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

Contacts
Principal investigator
Name 32253 0
Dr Paulo sergio Lucas da Silva
Address 32253 0
PEDIATRIC INTENSIVE CARE UNIT - HOSPITAL DO SERVIDOR PUBLICO MUNICIPAL
CASTRO ALVES, 60, LIBERDADE, SÃO PAULO
SÃO PAULO
BRAZIL
POSTCODE: 01532000
Country 32253 0
Brazil
Phone 32253 0
+5511996015472
Fax 32253 0
Email 32253 0
[email protected]
Contact person for public queries
Name 15500 0
Paulo Sergio Lucas da Silva
Address 15500 0
Hospital do Servidor Publico Municipal, Pediatric Intensive Care Unit
Rua Castro Alves, 60, Aclimacao, Sao Paulo, Brazil
01532-900
Country 15500 0
Brazil
Phone 15500 0
+551133972817
Fax 15500 0
Email 15500 0
[email protected]
Contact person for scientific queries
Name 6428 0
Paulo Sergio Lucas da Silva
Address 6428 0
Hospital do Servidor Publico Municipal, Pediatric Intensive Care Unit
Rua Castro Alves, 60, Aclimacao, Sao Paulo, Brazil
01532-900
Country 6428 0
Brazil
Phone 6428 0
+551133972817
Fax 6428 0
Email 6428 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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