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Trial registered on ANZCTR


Registration number
ACTRN12609000188235
Ethics application status
Approved
Date submitted
12/02/2009
Date registered
17/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized clinical trial of comparison between disposable and reusable laryngeal tube Suction-II(laryngeal tube S-II,LTS-II) for ventilation of patients undergoing laparoscopic cholecystectomy
Scientific title
A randomized clinical trial of comparison between disposable and reusable laryngeal tube Suction-II(laryngeal tube S-II,LTS-II) in anesthesia for ventilation of patients undergoing laparoscopic cholecystectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic cholecystectimy surgery 4320 0
Condition category
Condition code
Anaesthesiology 4555 4555 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A disposable laryngeal tube S-II will be used by the anaesthetist after induction of general anesthesia to ventilate the patients lungs with a mixture of oxygen and inhalational anaesthestics during surgery
Intervention code [1] 4050 0
Treatment: Devices
Comparator / control treatment
A reusable laryngeal tube S-II will be used by the anaesthetist after induction of general anesthesia to ventilate the patients lungs with a mixture of oxygen and inhalational anaesthestics during surgery
Control group
Active

Outcomes
Primary outcome [1] 5434 0
acceptable lung ventilation confirmed by auscultation of the chest and normal capnography
Timepoint [1] 5434 0
during surgery
Secondary outcome [1] 9131 0
quality of airway seal confirmed by sealing airway pressure measured by the anaesthesia machine
Timepoint [1] 9131 0
start of operation
Secondary outcome [2] 9132 0
post operative pharyngeal morbidity diagnosed by asking the patient by a blinded nurse
Timepoint [2] 9132 0
1 and 6 hours after the end of surgery
Secondary outcome [3] 9133 0
possibility of gastric insufflation confirmed by the surgeon when doing laparoscopy
Timepoint [3] 9133 0
during surgery

Eligibility
Key inclusion criteria
Elective surgery for laparoscopic cholecystectomy
Minimum age
16 Years
Maximum age
81 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
morbidly obese(body mass index>35kg/m²), upper respiratory tract symptoms in the previous 10 days, increased risk of aspiration(not fasted ,diabetes mellitus, or oesophageal pathology).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomised table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1568 0
Iran, Islamic Republic Of
State/province [1] 1568 0
Fars

Funding & Sponsors
Funding source category [1] 4493 0
Commercial sector/Industry
Name [1] 4493 0
Volker Bertram Medizintechnik[VBM]
Address [1] 4493 0
VBM Medizintechnik
Gesellschaft mit beschrankter Haftung [GmbH]
Einsteinstr. 1
DE-72172 Sulz a.N.
Country [1] 4493 0
Germany
Primary sponsor type
University
Name
Shiraz University of Medical Sciences
Address
Shiraz University of Medical Sciences, Zand Blvd. Shiraz,71345-1978, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 4056 0
Government body
Name [1] 4056 0
Anesthesiology and Critical Care Research Center
Address [1] 4056 0
Anesthesiology and Critical Care Research Center, Nemazee Hospital, Nemazee Square,71937-11351, Shiraz
Country [1] 4056 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6553 0
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Ethics committee address [1] 6553 0
Shiraz University of Medical Sciences, Zand Blvd. Shiraz,71345-1978, Iran
Ethics committee country [1] 6553 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6553 0
Approval date [1] 6553 0
12/11/2006
Ethics approval number [1] 6553 0
87-4293

Summary
Brief summary
The laryngeal tube suction II (LTS-II) is a recent version of supraglottic airway devices allowing gastric drainage. In this prospective, randomized study we compared insertion and ventilation of disposable LTS-II with reusable type for airway management under conditions with elevated intra abdominal pressure induced by capnoperitoneum.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29280 0
Address 29280 0
Country 29280 0
Phone 29280 0
Fax 29280 0
Email 29280 0
Contact person for public queries
Name 12527 0
Farid Zand MD
Address 12527 0
Department of Anaesthesiology
Nemazee Hospital
71937-11351
Shiraz
Country 12527 0
Iran, Islamic Republic Of
Phone 12527 0
+98-711-647-4270
Fax 12527 0
+98-711-647-4270
Email 12527 0
zandf@sums.ac.ir
Contact person for scientific queries
Name 3455 0
Farid Zand MD
Address 3455 0
Department of Anaesthesiology
Nemazee Hospital
71937-11351
Shiraz
Country 3455 0
Iran, Islamic Republic Of
Phone 3455 0
+98-711-647-4270
Fax 3455 0
+98-711-647-4270
Email 3455 0
zandf@sums.ac.ir

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary