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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

gynecologic laparoscopic surgery

Condition category

Condition code

Anaesthesiology

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]

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]

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]

after creation of pneumoperitoneum, and head down-tilt position, and at the end of surgery

Secondary outcome [1]

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]

after insertion and after pneumoperitoneum and head-down tilt position

Secondary outcome [2]

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]

after insertion

Secondary outcome [3]

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]

after insertion and after pneumoperitoneum and head-down tilt position

Secondary outcome [4]

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]

after insertion

Secondary outcome [5]

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]

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?

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]

Korea, Republic Of

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Chung-Ang University

Address [1]

224-1 Heukseok-Dong, Dongjak-Gu,

Seoul 156-755, Republic of Korea

Country [1]

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]

Individual

Name [1]

Chong Wha Baek

Address [1]

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]

Korea, Republic Of

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

20/10/2009

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

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

Phone

+82-2-6299-2571

Fax

+82-2-6299-2575

[email protected]

Contact person for scientific queries

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

Phone

+82-2-6299-2571

Fax

+82-2-6299-2575

[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

Source	Title	Year of Publication	DOI
Embase	Less perilaryngeal gas leakage with SLIPATM than with LMA-ProSealTM in paralyzed patients.	2011	https://dx.doi.org/10.1007/s12630-010-9412-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically