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Trial registered on ANZCTR


Registration number
ACTRN12615000699561
Ethics application status
Approved
Date submitted
11/06/2015
Date registered
3/07/2015
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Date results provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Differences in endotracheal tube cuff sealing by applying four methods of endotracheal tube cuff inflation in patients undergoing general surgery procedures
Scientific title
Assessment of four methods of endotracheal tube cuff inflation in terms of optimal cuff sealing in surgical population
Secondary ID [1] 286453 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endotracheal tube cuff sealing 294628 0
complications from endotracheal cuff tube overinflation 294629 0
Condition category
Condition code
Anaesthesiology 294928 294928 0 0
Anaesthetics
Respiratory 294929 294929 0 0
Other respiratory disorders / diseases
Injuries and Accidents 295563 295563 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After endotracheal intubation, we would apply four different methods for ETT cuff (ETTc) inflation in four different subgroups of patients (as they occur from randomization):
1) inflation of ETTc as usual practice and assessment of adequacy of inflation with finger estimation [Palpation],
2) ETTc will be overinflated and then it will be checked for air return back into the syringe [Air-return],
3) inflation of ETTc up to the point that no sound of air leakage will be heard by direct auscultation [minimal occlusive volume assessed by direct auscultation of air leak (MinVol)] and
4) inflation of ETTc up to the point that no sound of air leakage will be heard over trachea using stethoscope [minimum air leak assessed with stethoscope (MinLeak)].
The ETTc pressure will be measured with a non-invasive manometer via the pilot balloon.
The duration of each method is estimated to be less than 1 minutes for the first and second method and about 2 mnutes for the third and fourth method.
Intervention code [1] 291530 0
Early detection / Screening
Comparator / control treatment
The control treatment will be the application of a usual practice to assess the adequacy of ETTc inflation such as finger estimation, which will be tested against two less common methods of ETT cuff inflation estimation such as , minimal occlusive volume or minimum leak technique and one less applied method involving air return back into the syringe after cuff overinflation, with the view to ascertain optimal ETT cuff sealing practice in a surgical population.
Control group
Active

Outcomes
Primary outcome [1] 294687 0
The ETT cuff pressure obtained by each method of cuff inflation.
This will be based on the indications obtained by a non-invasive manometer applied in the pilot balloon.
Timepoint [1] 294687 0
Just after ETT cuff inflation
Primary outcome [2] 294688 0
The air needed for ETT cuff inflation in each method. This will be measured as ml of air used to inflate the cuff with a pre-filled with air 10 ml-syringe.
Timepoint [2] 294688 0
As soon as ETT cuff inflation is completed
Secondary outcome [1] 313864 0
Presence of complications such as sore throat, that might occur in each method of ETT cuff inflation. This will be based on patient's self-reporting of painful sensation localized to the pharynx or surrounding anatomy.
Timepoint [1] 313864 0
Two, six and twenty-four hours postoperatively
Secondary outcome [2] 315531 0
Presence of complications such as hoarseness (dysphonia) that might occur in each method of ETT cuff inflation. The patient will be assessed with the GRBAS scale. This is a subjective rating scale providing a measure of the overall grade (G), roughness (R), breathiness (B), asthenia or weakness (A), and strain (S) of dysphonia as judged by the listener on a scale of 0 to 4 (0: normal, 1: mild, 2: moderate, 3: moderate to severe, 4: severe).
Timepoint [2] 315531 0
Two, six and twenty-four hours postoperatively
Secondary outcome [3] 315532 0
Presence of complications such as dysphagia that might occur in each method of ETT cuff inflation. This will be assessed by Functional Oral Intake Scale numbered as 1 the worse and as 7 the best response.
Timepoint [3] 315532 0
Two, six and twenty-four hours postoperatively

Eligibility
Key inclusion criteria
Adult patients, ASA physical status 1 to 3, Mallampati score 1-2, oral endotracheal intubation with a high-volume and low-pressure endotracheal tube, N2O free general anesthesia, intraoperative normothermia, conventional mechanical ventilation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tracheostomy, surgical procedures involving the neck or the upper airwa, laryngo-tracheal pathology, history of previous tracheostomy, high-frequency oscillatory ventilation, history of difficult airway management, above 2 intubation attempts and prone positioning.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 34 patients in each group is estimated for a type 1 error of 0.05 (a=0.05) and a power of 90%. An estimated reduction in ETT cuff pressure > 4 cmH2O (SD 8 cmH2O) between palpation estimation and air-return after cuff overinflation techniques is defined as the primary end-point.
Analysis of variance (ANOVA) for repeated measures with Greenhouse–Geisser correction, Comparisons between different groups were performed using one-way ANOVA for comparisons between different groups and linear regression will be used as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2015
Actual
4/05/2015
Date of last participant enrolment
Anticipated
Actual
19/04/2016
Date of last data collection
Anticipated
Actual
19/04/2016
Sample size
Target
150
Accrual to date
Final
139
Recruitment outside Australia
Country [1] 6968 0
Greece
State/province [1] 6968 0

Funding & Sponsors
Funding source category [1] 291448 0
Self funded/Unfunded
Name [1] 291448 0
Country [1] 291448 0
Primary sponsor type
Individual
Name
Georgia Tsaousi
Address
Aristotle University of Thessaloniki, Greece
Stilponos Kiriakidi 1- GR 54636
University campus, Thessaloniki, Greece
Country
Greece
Secondary sponsor category [1] 290123 0
None
Name [1] 290123 0
Address [1] 290123 0
Country [1] 290123 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304815 0
Scientific Board of AHEPA University Hospital
Ethics committee address [1] 304815 0
Ethics committee country [1] 304815 0
Greece
Date submitted for ethics approval [1] 304815 0
30/01/2014
Approval date [1] 304815 0
31/03/2014
Ethics approval number [1] 304815 0
12625

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 498 498 0 0
/AnzctrAttachments/368282-Ethics Committee Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 56186 0
A/Prof Georgia Tsaousi
Address 56186 0
Aristotle University of Thessaloniki, Greece
Stilponos Kiriakidi 1 - GR54636
University Campus, Thessaloniki, Greece
Country 56186 0
Greece
Phone 56186 0
+302310994855
Fax 56186 0
Email 56186 0
tsaousig@otenet.gr
Contact person for public queries
Name 56187 0
Georgia Tsaousi
Address 56187 0
Aristotle University of Thessaloniki, Greece
Stilponos Kiriakidi 1 - GR54636
University Campus, Thessaloniki, Greece
Country 56187 0
Greece
Phone 56187 0
+302310994855
Fax 56187 0
Email 56187 0
tsaousig@otenet.gr
Contact person for scientific queries
Name 56188 0
Georgia Tsaousi
Address 56188 0
Aristotle University of Thessaloniki, Greece
Stilponos Kiriakidi 1 - GR54636
University Campus, Thessaloniki, Greece
Country 56188 0
Greece
Phone 56188 0
+302310994855
Fax 56188 0
Email 56188 0
tsaousig@otenet.gr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.