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Trial registered on ANZCTR


Registration number
ACTRN12605000592640
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
5/10/2005
Date last updated
27/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The VALID study: is ventilation affected by leaving in dentures?
Scientific title
To investigate whether bag-mask ventilation after induction of anaesthesia in patients with dentures is easier with dentures left in or removed.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Absent dentition 719 0
Condition category
Condition code
Anaesthesiology 796 796 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients randomised to Group A have their dentures removed after induction of anaesthesia but before bag-mask ventilation, while the patients randomised to Group B have their dentures left in for bag-mask ventilation and removed afterwards, prior to placement of endotracheal tube or laryngeal mask airway. Bag-mask ventilation is attempted in both groups of patients for 30 seconds after loss of eyelash reflex.
Intervention code [1] 535 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1017 0
Ease of bag-mask ventilation as determined by chest rise and fall
Timepoint [1] 1017 0
Measured for 30 seconds immediately after loss of eyelash reflex.
Primary outcome [2] 1018 0
Ease of bag-mask ventilation as determined by presence of etCO2 trace at 3 litres/min fresh gas flow
Timepoint [2] 1018 0
Measured for 30 seconds immediately after loss of eyelash reflex.
Primary outcome [3] 1019 0
Ease of bag-mask ventilation as determined by APL valve at 20cmH2O
Timepoint [3] 1019 0
Measured for 30 seconds immediately after loss of eyelash reflex.
Secondary outcome [1] 1907 0
Fresh gas flow required in litres/min.
Timepoint [1] 1907 0
Assessed for 30 seconds immediately after loss of eyelash reflex.
Secondary outcome [2] 1908 0
APL valve setting in cmH2O.
Timepoint [2] 1908 0
Assessed for 30 seconds immediately after loss of eyelash reflex.
Secondary outcome [3] 1909 0
Requirement to use oxygen flush valve.
Timepoint [3] 1909 0
Assessed for 30 seconds immediately after loss of eyelash reflex.
Secondary outcome [4] 1910 0
Requirement for oropharyngeal airway.
Timepoint [4] 1910 0
Assessed for 30 seconds immediately after loss of eyelash reflex.
Secondary outcome [5] 1911 0
Requirement for second person to assist to seal the mask.
Timepoint [5] 1911 0
Assessed for 30 seconds immediately after loss of eyelash reflex.

Eligibility
Key inclusion criteria
All patients with dentures undergoing general anaesthesia excluding those unable to give informed consent and those having rapid sequence induction were invited to participate
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequence concealed in numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block randomisation with random block size
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 208 0
New Zealand
State/province [1] 208 0

Funding & Sponsors
Funding source category [1] 885 0
Self funded/Unfunded
Name [1] 885 0
Address [1] 885 0
Country [1] 885 0
Primary sponsor type
Hospital
Name
Dunedin Public Hospital
Address
Country
New Zealand
Secondary sponsor category [1] 747 0
None
Name [1] 747 0
N/A
Address [1] 747 0
Country [1] 747 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36404 0
Address 36404 0
Country 36404 0
Phone 36404 0
Fax 36404 0
Email 36404 0
Contact person for public queries
Name 9724 0
Dr. Matthew Zacharias
Address 9724 0
Department of Anaesthesia
Dunedin Public Hospital
201 Great King St
Dunedin
Country 9724 0
New Zealand
Phone 9724 0
+64 3 4740999 ext. 8030
Fax 9724 0
+64 3 4747650
Email 9724 0
mzach@xtra.co.nz
Contact person for scientific queries
Name 652 0
Dr. Niamh Conlon
Address 652 0
Dept of Anesthesiology, PO Box 3094, Duke University Medical Center, Durham, NC 27710.
Country 652 0
United States of America
Phone 652 0
001 919 6811965
Fax 652 0
001 919 6818993
Email 652 0
tallniamh@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary