Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000105044
Ethics application status
Approved
Date submitted
30/01/2010
Date registered
2/02/2010
Date last updated
2/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of fibreoptic positioning of Proseal laryngeal mask airway with IGel in anaesthetised adult patients
Scientific title
Comparison of fibreoptic positioning of Proseal laryngeal mask airway with IGel in anaesthetised adult patients
Secondary ID [1] 1358 0
NONE
Universal Trial Number (UTN)
U-1111-1113-5300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
comparison of placement of supraglottic airway devices to ventilate patients during anaesthesia 256717 0
Condition category
Condition code
Anaesthesiology 256876 256876 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Proseal laryngeal mask airway is a supraglottic airway with dorsal and ventral cuff, and drain tube to aid gastric tube insertion. These features improve ventilatory parameters and decrease incidence of stomach inflation. Igel is a supraglottic airway device without cuff and drain tube to aid gastric tube insertion. Igel has been touted to have better success rates and decreased airway trauma due to absence of cuff and comparable ventilatory parameters. The entire duration of airway tube insertion takes less than 1 minute. Igel and Proseal Laryngeal mask airway are regularly used during anaesthesia.
Intervention code [1] 255945 0
Treatment: Devices
Comparator / control treatment
Proseal laryngeal mask airway acts as control group
Control group
Active

Outcomes
Primary outcome [1] 257744 0
Fibreoptic comparison of placement of Proseal laryngeal mask airway with IGel. Fibreoptic bronchoscope will be introduced through airway tube of Proseal laryngeal mask airway and I-Gel and the fibreoptic view will be scored according to an established scoring system: Grade 4 -only vocal cords, Grade 3-vocal cords plus posterior epiglottis, Grade 2 -vocal cords plus anterior epiglottis, Grade 1-cords not seen but functions adequately
Timepoint [1] 257744 0
During anaesthesia
Secondary outcome [1] 263115 0
Time to insert airway. Time taken to insert airway is measured from the time anaesthetist takes the airway to the time square wave pattern is seen on capnography.
Timepoint [1] 263115 0
During anaesthesia
Secondary outcome [2] 263116 0
Failed insertion attempts. Criteria for failed insertion include airleak over oropharynx, stomach and ineffective ventilation (Exhaled tidal volume <8ml/kg, End tidal carbondioxide >45mmHg. In the event of failed insertion after three attempts, patient will be intubated with endotracheal tube and surgery is allowed to proceed.
Timepoint [2] 263116 0
During anaesthesia
Secondary outcome [3] 263117 0
Oropharyngeal leak pressure. Oropharyngeal leak pressure is defined as the pressure at which audible leak is heard at a constant flow of 6L/min with Adjustable Pressure Leak valve kept closed.
Timepoint [3] 263117 0
During anaesthesia
Secondary outcome [4] 263119 0
Ease of gastric tube insertion.After the airway is secured in position, gastric tube (12F Gauge) will be inserted through drain tube of Proseal Laryngeal mask airway and I-Gel and ease of insertion graded as easy, difficult and inability to insert gastric tube.
Timepoint [4] 263119 0
During anaesthesia
Secondary outcome [5] 263121 0
Postoperative airway morbidity. It is assessed by blinded observers regarding presence of sore throat, dysphagia, dysphonia.
Timepoint [5] 263121 0
During anaesthesia

Eligibility
Key inclusion criteria
Patients undergoing elective minor surgeries of patient status American Society of Anaesthesiologists (ASA) I and II
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with difficult airway, potential full stomach and emergency surgeries

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number
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
15/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment outside Australia
Country [1] 2451 0
India
State/province [1] 2451 0
TAMILNADU

Funding & Sponsors
Funding source category [1] 256442 0
Hospital
Name [1] 256442 0
SRM (SRI RAMASAMY MEMORIAL) MEDICAL COLLEGE
Country [1] 256442 0
India
Primary sponsor type
Hospital
Name
SRM Medical college
Address
SRM Nagar,
Kattankulathur-603203.
kanchipuram district
Tamilnadu
Country
India
Secondary sponsor category [1] 255741 0
None
Name [1] 255741 0
Address [1] 255741 0
Country [1] 255741 0
Other collaborator category [1] 1095 0
Individual
Name [1] 1095 0
JAYAKAR GURUSAMY
Address [1] 1095 0
ASSISTANT PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY
SRM MEDICAL COLLEGE
KATTANKULATHUR-603203
KANCHIPURAM DISTRICT
Country [1] 1095 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258498 0
Institutional Ethical Committee (IEC), SRM Medical college
Ethics committee address [1] 258498 0
Ethics committee country [1] 258498 0
India
Date submitted for ethics approval [1] 258498 0
01/08/2009
Approval date [1] 258498 0
12/08/2009
Ethics approval number [1] 258498 0
13/IEC/09

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

Contacts
Principal investigator
Name 30791 0
Address 30791 0
Country 30791 0
Phone 30791 0
Fax 30791 0
Email 30791 0
Contact person for public queries
Name 14038 0
ANAND KUPPUSAMY
Address 14038 0
ASSISTANT PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY
SRM MEDICAL COLLEGE HOSPITAL
KATTANKULATHUR-603203
TAMILNADU
Country 14038 0
India
Phone 14038 0
91-9865282288
Fax 14038 0
Email 14038 0
[email protected]
Contact person for scientific queries
Name 4966 0
ANAND KUPPUSAMY
Address 4966 0
ASSISTANT PROFESSOR
DEPARTMENT OF ANAESTHESIOLOGY
SRM MEDICAL COLLEGE HOSPITAL
KATTANKULATHUR-603203
TAMILNADU
Country 4966 0
India
Phone 4966 0
91-9865282288
Fax 4966 0
Email 4966 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.