Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000191998
Ethics application status
Not yet submitted
Date submitted
11/01/2011
Date registered
18/02/2011
Date last updated
18/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
comparing low flow anesthesia between endotracheal tube and laryngeal mask airway during controlled ventilation
Scientific title
Comparison of postoperative complication between Laryngeal Mask Airway and Endotracheal tube during low flow anesthesia with controlled ventilation
Secondary ID [1] 253383 0
There is not any secondary ID
Universal Trial Number (UTN)
U1111-1118-9841
Trial acronym
There is not any trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative Cough and shivering 261158 0
Condition category
Condition code
Anaesthesiology 259067 259067 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maintanance of anesthesia will be done with low flow anesthesia (with isofulane2% at first and fresh gasflow 6 lit/min for ten minutes and after that fresh gas flow decreases to 1 lit/min and isoflurane to 1 lit/min) through Laryngeal Mask Airway and postoperative complications will be assessed
Intervention code [1] 257826 0
Treatment: Drugs
Comparator / control treatment
Maintanance of anesthesia will be done with low flow anesthesia(with isofulane2% at first and fresh gasflow 6 lit/min for ten minutes and after that fresh gas flow decreases to 1 lit/min and isoflurane to 1 lit/min) through Endotracheal Tube and postoperative complications will be assessed
Control group
Active

Outcomes
Primary outcome [1] 259921 0
Post operative complications(shivering,sore thoat and cough

) with patient self-reported questionnaires
Timepoint [1] 259921 0
Post operation till day 3 once time daily
Primary outcome [2] 259922 0
Intraoperative leakage( via ventilator) and end tidal co2 by capnography
Timepoint [2] 259922 0
During operation
Secondary outcome [1] 268818 0
Safety ,if there is not any complication intraoperative(leak) and postoperative(cough,shivering,dysphagy) with clinical assessment and monitoring.
Timepoint [1] 268818 0
during operation and 24h post operative

Eligibility
Key inclusion criteria
Adult patients(between 20-70 y.o), with ASA physical status I-II, who are candidated to elective surgery
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Difficult airway, upper respiratory tract infection and sore throat during past 10 days, allergy to latex and not being fasted.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 3136 0
Iran, Islamic Republic Of
State/province [1] 3136 0
East Azerbaijan

Funding & Sponsors
Funding source category [1] 258299 0
University
Name [1] 258299 0
Tabriz University of Medical Sciences
Country [1] 258299 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tabriz University of Medical Sciences
Address
Golgasht street, Tabriz
5157663114
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257659 0
None
Name [1] 257659 0
Address [1] 257659 0
Country [1] 257659 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260284 0
Ethics committee of Tabriz University of Medical Sciences
Ethics committee address [1] 260284 0
Tabriz University, Daneshgah street, Tabriz
5157663114
Ethics committee country [1] 260284 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260284 0
14/10/2010
Approval date [1] 260284 0
Ethics approval number [1] 260284 0

Summary
Brief summary
Laryngeal Mask Airway(LMA) is a good alternative for endotracheal tube during anesthesia. Closed system in anesthesia has some advantages like better control of airway temperature and humidification, lower cost and lower polution of operative room, so nowadays clinician like to use this way for maintenance of anesthesia.As good sealing is a concern about LMA, so there are some controversies about the usage of closed system during
controlled ventilation with LMA. 80 patients will be enrolled in this study. Patients will randomized to two 40 patient groups. in one group anesthesia will be maintained with low flow anesthesia by LMA and controlled ventilation and in the other group anesthesia will be maintained through endotracheal tube and controlled ventilation.Intraoperative hemodynamic parameters ,end tidal co2 and leak and also postoperative sorethroat, shivering and cough will be assessed for each patient.
Trial website
There is not any web site for this trial.
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32077 0
Address 32077 0
Country 32077 0
Phone 32077 0
Fax 32077 0
Email 32077 0
Contact person for public queries
Name 15324 0
Ata Mahmoodpoor
Address 15324 0
General ICU,Shohada hospital, El-Goli street, Tabriz
5157663114
Country 15324 0
Iran, Islamic Republic Of
Phone 15324 0
00984113851117
Fax 15324 0
00984113853171
Email 15324 0
[email protected]
Contact person for scientific queries
Name 6252 0
Ata Mahmoodpoor
Address 6252 0
General ICU,Shohada hospital, El-Goli street, Tabriz
5157663114
Country 6252 0
Iran, Islamic Republic Of
Phone 6252 0
00984113851117
Fax 6252 0
00984113853171
Email 6252 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.