Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000253808
Ethics application status
Approved
Date submitted
29/02/2012
Date registered
29/02/2012
Date last updated
29/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of choosing the optimal size of Streamlined liner of Pharyngeal Airway(SLIPA) estimated by patient's height and the width of thyroid cartilage in normal adults
Scientific title
A comparison of choosing the optimal size by measuring OLP(oropharyngeal leakage pressure) and inspiratory and expiratory tidal volume, of Streamlined liner of Pharyngeal Airway(SLIPA) estimated by patient's height and the width of thyroid cartilage in normal adults undergoing minor surgery in 2 hours with supine position.
Secondary ID [1] 280040 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing minor surgery in 2 hours with supine position 285954 0
Condition category
Condition code
Anaesthesiology 286141 286141 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sizing is performed before induction of anesthesia.It takes approximately 5 minutes.
The SLIPA size is chosen by matching the width across the thyroid cartilage with that of the bridge of the SLIPA.
Dimension is sized between left and right cornu of thyroid cartilage by palpation and matching the dimension at level the widest diameter of SLIPA bridge.
Intervention code [1] 284365 0
Treatment: Devices
Intervention code [2] 284378 0
Treatment: Surgery
Comparator / control treatment
Sizing is performed before induction of anesthesia. It takes approximately 5 minutes.
SLIPA size is selected by measuring the patient's height, and followed the SLIPA manufacturer's criteria.
Control group
Active

Outcomes
Primary outcome [1] 286614 0
measure the OLP(Oropharyngeal leakage pressure) by auscultation. OLP is the minimum airway pressure at which gas audibly leak around it using a fresh gas flow of
5 liter/min with the adjustable pressure-limiting (APL)
valve completely closed.
If <15mmHg, repositoning the patient's head and neck.
If OLP shows <15mmHg after repositioning, it regards as fail.
Timepoint [1] 286614 0
immediately after insertion device
Primary outcome [2] 286615 0
Respiratory mechanics
Peak Inspiratory pressure, Inspiratory tidal Volume, Expiratory tidal volume will be measured using spirometry module (S/5TM Compact anaesthesia monitor; Datex-Ohmeda, Tewksbury, MA, USA). All manipulations of the patients will be halted during the measurement, and respiratory mechanics variables will be measured in triplicate and averaged for each measurement, such that each measured data will be used as a single observation and contribute only once to each overall data set.
Timepoint [2] 286615 0
after 5 minutes after induction of anesthesia
Secondary outcome [1] 296276 0
severity of sore throat
30 min after arrival in the recovery room, patients will be asked by the independent investigator to score throat pain on an eleven-point visual analogue scale(0-10)
Timepoint [1] 296276 0
30 min after arrival in the recovery room

Eligibility
Key inclusion criteria
ASA 1,2 patients undergoing minor surgery in 2 hours with supine position.
upper and lower limbs surgery and transurethral approach, for example.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
obesity (body mass index > 30 kg m–2), existing respiratory disease, history of upper gastrointestinal surgery, hiatus hernia, gastroesophagus reflux disease, gastric ulcer, risk of aspiration or regurgitation.

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)
The details of the series are kept in a set of sealed envelopes, each bearing only the case number on the outside. After admitting into the operating room and just before the induction of anaesthesia, the numbered envelope was opened and the card inside determined which group the patient would be affiliated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of the two groups was based on Excel random-number generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4177 0
Korea, Republic Of
State/province [1] 4177 0

Funding & Sponsors
Funding source category [1] 284797 0
University
Name [1] 284797 0
Chung-Ang University
Country [1] 284797 0
Korea, Republic Of
Primary sponsor type
University
Name
Chung-Ang University
Address
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country
Korea, Republic Of
Secondary sponsor category [1] 283688 0
None
Name [1] 283688 0
Address [1] 283688 0
Country [1] 283688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286784 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 286784 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 286784 0
Korea, Republic Of
Date submitted for ethics approval [1] 286784 0
Approval date [1] 286784 0
Ethics approval number [1] 286784 0

Summary
Brief summary
SLIPA is an widespread supraglottic airway. But, the size selection criteria provided from manufacturer is inaccurate and the height is overlapped. Therefore we performed a study to find the factors influencing selection of the optimal size of Streamlined liner of Pharyngeal Airway(SLIPA) in normal adults, especially the width of thyroid.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33844 0
Address 33844 0
Country 33844 0
Phone 33844 0
Fax 33844 0
Email 33844 0
Contact person for public queries
Name 17091 0
Hyun Kang
Address 17091 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 17091 0
Korea, Republic Of
Phone 17091 0
+82-2-6299-2571, 2579, 2586
Fax 17091 0
+82-2-6299-2585
Email 17091 0
[email protected]
Contact person for scientific queries
Name 8019 0
Hyun Kang
Address 8019 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 8019 0
Korea, Republic Of
Phone 8019 0
+82-2-6299-2571, 2579, 2586
Fax 8019 0
+82-2-6299-2585
Email 8019 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseStreamlined Liner of the Pharynx Airway: Randomised comparison of size selection strategies with regard to patient height versus thyroid cartilage width.2015http://dx.doi.org/10.1177/102490791502200507
N.B. These documents automatically identified may not have been verified by the study sponsor.