Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001189910
Ethics application status
Approved
Date submitted
15/11/2011
Date registered
16/11/2011
Date last updated
16/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of proseal laryngeal mask airway and Streamlined Liner of the Pharynx Airway for gastric distension in the patients undergoing laparoscopic cholecystectomy.
Scientific title
Comparision of degree of gastric distension between proseal laryngeal mask airway and Streamlined Liner of the Pharynx Airway when used in the patients undergoing laparoscopic cholecystectomy.
Secondary ID [1] 273396 0
None
Universal Trial Number (UTN)
Trial acronym
SLIPA=Streamlined Liner of the Pharynx Airway LMA-P=proseal laryngeal mask airway
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing laparoscopic cholecystectomy 279174 0
Condition category
Condition code
Anaesthesiology 279372 279372 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of SLIPA
Insertion technique is based on manufacturer's recommendation.
To insert the device, the mouth is opened and the toe of the SLIPA is put into the mouth and advanced towards the posterior pharyngeal arch. At this stage, a 'jaw thrust' is applied by left hand and SLIPA is advanced caudally until the SLIPA slip into correct position.
Insertion may takes about 30 second and SLIPA may be used during the operation.
Intervention code [1] 283730 0
Treatment: Devices
Comparator / control treatment
Insertion of LMA-P Insertion technique is based on manufacturer's recommendation. To insert the device, the mouth is opened and the toe of the LMA-P is put into the mouth and advanced towards the posterior pharyngeal arch. At this stage, a 'jaw thrust' is applied by left hand and LMA-P is advanced caudally until the LMA-P slip into correct position. Insertion may takes about 30 second and LMA-P may be used during the operation. As the SLIPA and LMA-P are the types of supralaryngeal airway, the technique to insert LMA-P and SLIPA is overally the same.
Control group
Active

Outcomes
Primary outcome [1] 285962 0
Degree of gastric distension
The surgeon, who did not know which devices were used, scored gastric distension score by direct visualizing laparoscope using visual analogue scale was from 0 to 10 (0 = empty stomach, 10 = distension that interfered with surgical exposure)
Timepoint [1] 285962 0
after creation of pneumoperitoneum, and at the end of surgery
Secondary outcome [1] 294855 0
Respiratory mechanics
Peak inspiratory pressure (PIP), plateau pressure(Ppla), inspiratory tidal volume(VT), expiratory VT, static respiratory system compliance(Cst,rs), inspiratory resistance(RI, rs) 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 [1] 294855 0
after insertion and after pneumoperitoneum
Secondary outcome [2] 294856 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 [2] 294856 0
after operation
Secondary outcome [3] 294857 0
anatomical fit
Anatomical fit will be checked using a flexible fiberoptic bronchoscope (Olympus BF-3C40, Olympus Optical, Tokyo, Japan) and this was graded by consent of second anesthesiologist.
The fiberoptic view at the deflection bulb of the SLIPA and distal end of airway tube of LMA-P will be assessed by 3 factor: epiglottis (0 = not visible, 1 = posterior aspect of epiglottis seen, 2 = only tip or partial epiglottis seen, 3 = anterior or nearly total epiglottis seen), anterior and posterior aspect of vocal cord (0 = not visible, 1 = visible).
Timepoint [3] 294857 0
after insertion of SLIPA or LMA-P

Eligibility
Key inclusion criteria
ASA 1,2 patietns undergoing elective laparoscopic cholecystectomy under general anesthesia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of diabetes mellitus, gastroesophageal reflux, other neurologic or musculoskelectal disease, obesity (body mass index > 30 kg m–2) and with features or history of a difficult airway

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)
based on computer-generated codes that were maintained in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
excel generating random number
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
13/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment outside Australia
Country [1] 3950 0
Korea, Republic Of
State/province [1] 3950 0

Funding & Sponsors
Funding source category [1] 284212 0
University
Name [1] 284212 0
Chung-Ang University
Country [1] 284212 0
Korea, Republic Of
Primary sponsor type
Individual
Name
Hyun Kang
Address
Department of Anesthesiology and Pain Medicine
College of Medicine
Chung-Ang University

224-1 Heukseok-Dong, Dongjak-Gu,
Seoul 156-755, Republic of Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 269169 0
Individual
Name [1] 269169 0
Su Man Cha
Address [1] 269169 0
Department of Anesthesiology and Pain Medicine
College of Medicine, Ajou University, Suwon
Country [1] 269169 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286174 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 286174 0
Ethics committee country [1] 286174 0
Korea, Republic Of
Date submitted for ethics approval [1] 286174 0
20/06/2011
Approval date [1] 286174 0
13/07/2011
Ethics approval number [1] 286174 0
c2011091(541)

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

Contacts
Principal investigator
Name 33396 0
Address 33396 0
Country 33396 0
Phone 33396 0
Fax 33396 0
Email 33396 0
Contact person for public queries
Name 16643 0
Hyun Kang
Address 16643 0
Department of Anesthesiology and Pain Medicine
College of Medicine
Chung-Ang University
224-1 Heukseok-Dong, Dongjak-Gu,
Seoul 156-755, Republic of Korea
Country 16643 0
Korea, Republic Of
Phone 16643 0
+82-2-6299-2571
Fax 16643 0
+82-2-6299-2575
Email 16643 0
[email protected]
Contact person for scientific queries
Name 7571 0
Hyun Kang
Address 7571 0
Department of Anesthesiology and Pain Medicine
College of Medicine
Chung-Ang University
224-1 Heukseok-Dong, Dongjak-Gu,
Seoul 156-755, Republic of Korea
Country 7571 0
Korea, Republic Of
Phone 7571 0
+82-2-6299-2571
Fax 7571 0
+82-2-6299-2575
Email 7571 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
No additional documents have been identified.