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Trial registered on ANZCTR


Registration number
ACTRN12609000914268
Ethics application status
Approved
Date submitted
20/10/2009
Date registered
22/10/2009
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of proseal laryngeal mask airway and Streamlined Liner of the Pharynx Airway in the paralyzed patients undergoing gynaecologic laparoscopic surgery.
Scientific title
Comparision of incidence of gastric insufflations, stability, sealing pressure and respiratory mechanics, ease of insertion, number of repositioning attempts, and incidence or severity of sore throat between
proseal laryngeal mask airway and Streamlined Liner of the Pharynx Airway when used in the paralyzed patients undergoing gynaecologic laparoscopic surgery.
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:
anesthesized patients 252034 0
gynecologic laparoscopic surgery 252035 0
Condition category
Condition code
Anaesthesiology 252223 252223 0 0
Anaesthetics

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] 241431 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.
Control group
Active

Outcomes
Primary outcome [1] 253097 0
incidence of gastric insufflation
After creation of pneumoperitoneum, and head down-tilt position, and at the end of surgery, gastric air insufflations will be monitored using stethoscope positioned over the patients stomach and through a direct visualization of stomach through a laparoscope.
Timepoint [1] 253097 0
after creation of pneumoperitoneum, and head down-tilt position, and at the end of surgery
Secondary outcome [1] 257957 0
stability
We will asses stability of SLIPA and LMA-P by checking the difference between inspiratory and expiratory tidal volume and leakage sound when move patients head flexion or extension, turn the patient?s head to left and right.
Timepoint [1] 257957 0
after insertion and after pneumoperitoneum and head-down tilt position
Secondary outcome [2] 257958 0
sealing pressure
Maximum airway sealing pressure will be measured by closing the expiratory valve of the breathing circuit and noting the pressure at which a leak developed with a fixed fresh gas flow of 3L/min.
Timepoint [2] 257958 0
after insertion
Secondary outcome [3] 257959 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 [3] 257959 0
after insertion and after pneumoperitoneum and head-down tilt position
Secondary outcome [4] 257960 0
ease of insertion
Anesthesiologists who insert SLIPA and LMA-P will be asked to relate whether they found it ,very easy, easy, difficult, very difficult to insert.
Timepoint [4] 257960 0
after insertion
Secondary outcome [5] 257961 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 [5] 257961 0
after operation

Eligibility
Key inclusion criteria
undergoing elective laparoscopic gynaecologic procedure under general anaesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
suffered from diabetes mellitus, morbid obesity or gastroesophageal reflux, at risk of aspiration
or severe cardio-pulmonary disease, neurologic, nephrologic, oncologic, disease

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
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment outside Australia
Country [1] 2271 0
Korea, Republic Of
State/province [1] 2271 0

Funding & Sponsors
Funding source category [1] 243903 0
University
Name [1] 243903 0
Chung-Ang University
Country [1] 243903 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] 251247 0
Individual
Name [1] 251247 0
Chong Wha Baek
Address [1] 251247 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 [1] 251247 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244018 0
Ethics committee address [1] 244018 0
Ethics committee country [1] 244018 0
Date submitted for ethics approval [1] 244018 0
20/10/2009
Approval date [1] 244018 0
Ethics approval number [1] 244018 0

Summary
Brief summary
The Streamlined linear of the pharryngeal airway(SLIPA) is a new type of supralaryngeal airway(SLA), use of which has increased because it is inexpensive, disposable and easy to insert.
Although other SLA(eg, laryngeal mask airway(LMA), laryngeal tube) have been used safely in elective gynaecologic laparoscopic surgery, there are few reports compare the characteristics of the SLIPA or proseal LMA(LMA-P) when used in paralyzed patients undergoing gynecologic laparoscopic surgery.
We wish to provide the incidence of gastric insufflations, stability, sealing pressure and respiratory mechanics of SLIPA when used in the paralyzed patients receiving elective gynecologic laparoscopic surgery, to compare it with LMA-P. We also wish to compare the SLIPA with LMA-P in a clinical setting with regard to ease of insertion, number of repositioning attempts, and incidence or severity of sore throat.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30400 0
Address 30400 0
Country 30400 0
Phone 30400 0
Fax 30400 0
Email 30400 0
Contact person for public queries
Name 13647 0
Hyun Kang
Address 13647 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 13647 0
Korea, Republic Of
Phone 13647 0
+82-2-6299-2571
Fax 13647 0
+82-2-6299-2575
Email 13647 0
[email protected]
Contact person for scientific queries
Name 4575 0
Hyun Kang
Address 4575 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 4575 0
Korea, Republic Of
Phone 4575 0
+82-2-6299-2571
Fax 4575 0
+82-2-6299-2575
Email 4575 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
EmbaseLess perilaryngeal gas leakage with SLIPATM than with LMA-ProSealTM in paralyzed patients.2011https://dx.doi.org/10.1007/s12630-010-9412-3
N.B. These documents automatically identified may not have been verified by the study sponsor.