Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000498897
Ethics application status
Approved
Date submitted
8/05/2012
Date registered
9/05/2012
Date last updated
9/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of operator experience and method in the inflation of endotracheal tube pilot balloon on cuff pressure
Scientific title
Effects of operator experience and method in the inflation of endotracheal tube pilot balloon on cuff pressure in patients undergoing elective surgery in the supine position
Secondary ID [1] 280451 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endotracheal tube cuff pressure 286429 0
Condition category
Condition code
Anaesthesiology 286680 286680 0 0
Other anaesthesiology
Respiratory 286681 286681 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1)Operators were divided into following groups according to experiences:
Group T1 (n=50): Anesthesia technician with less (than two years) experience (5 operators)
Group T2 (n=50): Anesthesia technician with more (than two years) experience (5 operators)
Group A1 (n=50): Research assistant doctor with less (than three years) experience (5 operators)
Group A2 (n=50): Research assistant doctor with more (than three years) experience (5 operators)
2) After intubation, endotracheal tube cuff was inflated by two different methods, until the leakage sound was discontinuated or pilot balloon palpation by operators.
Each of the operator from these groups were to conduct the application on 10 patients, and endotracheal tube cuffs were inflated according to leakage sound in half of the patients (n=5) and pilot balloon palpation in the other half (n=5).
3) After endotracheal entubation, cuff was inflated immediately. cuff pressures were measured at the 5th and 60th minutes of endotracheal intubation and immediately before emergence from anesthesia
Intervention code [1] 284811 0
Other interventions
Comparator / control treatment
Group S (n=50): Specialist doctor (5 operators)
Control group
Active

Outcomes
Primary outcome [1] 287082 0
endotracheal cuff pressure (via aneroid manometer)
In case the cuff pressure was above 30 cmH2O or below 20 cmH2O, the pressure was intervened to bring back to normal limits
Timepoint [1] 287082 0
at the 5th and 60th minutes of endotracheal intubation, and immediately before emergence from anesthesia
Secondary outcome [1] 297333 0
Postoperative complaint
(sore throat, hoarseness of voice, coughing, and dysphagia)
Timepoint [1] 297333 0
at the PACU
at the postoperative 24th hour
(present/absent)

Eligibility
Key inclusion criteria
16-60 years old,
ASA status I-III,
elective surgery in supine position,
endotracheal tube inner diameter 7 -8.5 mm,
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
head-neck surgery,
urgent or difficult intubation,
an operation period less than 60 minutes,
endotracheal tube inner diameter less than 7 mm or more than 8.5 mm,
Mallampati score of III-IV,
high aspiration risk (full stomach, pregnancy),
diabetes mellitus, congenital, laryngotracheal and rheumatic diseases

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 4291 0
Turkey
State/province [1] 4291 0
Elazig

Funding & Sponsors
Funding source category [1] 285211 0
Self funded/Unfunded
Name [1] 285211 0
Country [1] 285211 0
Primary sponsor type
Hospital
Name
Firat University Hospital
Address
Firat University Hospital Anesthesiology and Reanimation Department 23119 Elazig
Country
Turkey
Secondary sponsor category [1] 284083 0
None
Name [1] 284083 0
Address [1] 284083 0
Country [1] 284083 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287212 0
Firat University Ethics Committee of Clinical Studies Conducted in Humans
Ethics committee address [1] 287212 0
Firat University Ethics Committee
Firat University Medicine Faculty
23119 Elazig
Ethics committee country [1] 287212 0
Turkey
Date submitted for ethics approval [1] 287212 0
07/02/2011
Approval date [1] 287212 0
10/03/2011
Ethics approval number [1] 287212 0

Summary
Brief summary
Background: In this study, we planned to investigate the effects of operator experience and cuff pressure inflation method differences following endotracheal tube cuff pressure (ETCP) and complaints about it.
Materials and methods: Two hundred fifty patients were planned general anesthesia included in this study. ETC was inflated by operators with distinct experience according to leakage or pilot balloon palpation techniques. ETCPs were measured by manometer at three periods as 5 and 60 minutes after endotracheal intubation, and before emergence. Complaints about it were recorded in post anesthetic care unit and postoperative 24th hour.
Results: Though we found experience of operator had significant effect on the ETCP, we observed inflation methods hadn’t effect. But experienced operators also were found ETCP was higher than normal range. A correlation was observed between cuff pressure and operation duration with postoperative complaints.
Conclusions: Our study concluded that used methods do not have an precede over one another, ETC inflated at normal pressure increases as operator’s experience increases but experience does not suffice alone in adjusting ETCP, a healthier method such as manometer should be used in routine applications instead of conventional methods, and CP and operation duration have correlations with some postoperative complaints.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34147 0
Address 34147 0
Country 34147 0
Phone 34147 0
Fax 34147 0
Email 34147 0
Contact person for public queries
Name 17394 0
Ayse Belin OZER
Address 17394 0
Firat University Medicine Faculty Anesthesiology and Reanimation Department 23119 Elazig
Country 17394 0
Turkey
Phone 17394 0
+90 424 2333555
Fax 17394 0
+90 424 2388096
Email 17394 0
abelinozer@gmail.com
Contact person for scientific queries
Name 8322 0
Ayse Belin OZER
Address 8322 0
Firat University Medicine Faculty Anesthesiology and Reanimation Department 23119 Elazig
Country 8322 0
Turkey
Phone 8322 0
+90 424 2333555
Fax 8322 0
+90 424 2388096
Email 8322 0
abelinozer@gmail.com

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No Supporting Document Provided



Results publications and other study-related documents

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