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1 Clinical Trial Details (PDF Generation Date :- Tue, 09 Oct :20:25 GMT) CTRI Number Last Modified On 26/09/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/10/ [Registered on: 03/10/2012] - Trial Registered Retrospectively Yes Interventional Surgical/Anesthesia Randomized, Parallel Group Trial comparison of effectiveness of an airway equipment- the airtraq- when it is used with or without an additional equipment- the bougie Role of gum elastic bougie with Airtraq optical laryngoscope for endotracheal intubation- aid or impediment: a comparative study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) IEC 110/2011 Name Designation Affiliation Address Phone Fax Name Designation Affiliation Address Other Details of Principal Investigator dr Eeshwar Rao post graduate department of anaesthesiology department of anaesthesiology kasturba hospital Manipal Udupi KARNATAKA India dreeshwar@gmail.com Details Contact Person (Scientific Query) Gurudas Kini Professor Phone Fax Name Designation Affiliation Address Phone Fax department of anaesthesiology department of anaesthesiology kasturba hospital Manipal Udupi KARNATAKA India kini.gurudas@gmail.com Details Contact Person (Public Query) dr jasvinder kaur assistant professor department of anaesthesiology, KMC, Manipal University department of anaesthesiology kasturba hospital Manipal Udupi KARNATAKA India jasvinder08@gmail.com page 1 / 39

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria > Kasturba Hospital, KMC, Manipal Name Source of Monetary or Material Support Primary Sponsor Details Kasturba Hospital KMC Manipal Address Kasturba Hospital, KMC, Manipal, karnataka-india Type of Sponsor Name NIL List of Countries India Name of Principal Investigator dr jasvinder kaur Research institution and hospital Address NIL Name of Site Site Address Phone/Fax/ operation teatre complex operation rooms 1-11,deparment of anesthesia,kasturba medical college hospital, manipal Udupi KARNATAKA jasvinder08@gmail.com Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? IEC, Kasturba Hospital, KMC Manipal Status Not Applicable Health Type Patients Approved 12/04/2011 No Date No Date Specified Condition Type Name Details normal healthy patients undergoing elective surgery under general endotracheal anaesthesia Comparator Agent Airtraq Airtraq will be used for endotracheal intubation Intervention Airtraq with bougie Airtraq with bougie will be used for endotracheal intubation Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria scheduled to undergo elective surgery under general endotraheal anaesthesia Exclusion Criteria Emergency surgeries requiring rapid sequence induction of anaesthesia and patients with full stomach Patients with known orofacial or laryngo pharyngeal pathology Having known cardio pulmonary disease Patients with restricted mouth opening/ anticipated difficult airway Body mass index more than 35kg/m2 Method of Generating Random Sequence Method of Computer generated randomization Sequentially numbered, sealed, opaque envelopes page 2 / 39

3 Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Time of intubation Ease of intubation Maneuvers employed to facilitate intubation Number of attempts during intubation and immediately following intubation Secondary Outcome Outcome Timepoints Trauma during intubation attempts : noted if any blood observed on Airtraq blade at end of intubation attempt or in the oral cavity on a repeat intubation attempt Undue hypertension/ hypotension Undue bradycardia/tachycadria Desaturation/ bronchospasm during intubation and immediately following intubation Target Sample Size Phase of Trial Phase 4 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Total Sample Size=75 Sample Size from India=75 02/05/2011 No Date Specified Years=1 Months=6 Days=0 Not Applicable Open to Recruitment nil After initiation of standard monitoring (ECG, NIBP, SPO 2 )and page 3 / 39

4 intravenous access will be secured. The monitor will be set to record NIBP every minute, and to alarm if either the BP or heart rate deviate page 4 / 39

5 greater than 25% from baseline during the course of the study. Intravenous glycopyrrolate 0.2mg and Fentanyl 2µg/kg i.v. will be page 5 / 39

6 administered and patients will be preoxygenated for 3 minutes, with addition of End tidal CO 2 monitoring. Anaesthesia will be induced page 6 / 39

7 with propofol 3mg/kg. Loss of verbal response will be taken as the end point of anaesthetic induction. Post induction, a peripheral nerve page 7 / 39

8 stimulator monitoring train of four (TOF) count over the ulnar nerve will be secured. After confirming adequacy of mask ventilation, page 8 / 39

9 neuromuscular blockade will be achieved with vecuronium bromide 0.12mg/kg, and anaesthesia will be deepened with 1.5 to2% page 9 / 39

10 isoflurane in oxygen, to achieve an end tidal MAC of at least 1. Laryngoscopy will be attempted, once the TOF count is zero and an page 10 / 39

11 adequate end tidal MAC is achieved. As per group allocation, the Airtraq will be prepared by lubricating its page 11 / 39

12 ETT channel and placing an ETT in it, as indicated below 1. ETT alone in group A 2. ETT with well lubricated bougie inserted upto the page 12 / 39

13 murphy s eye in group AB such that, when protruded through the ETT, the bougie curves anteriorly. For groups A and AB, 7mmID ETT loaded in the green Airtraq (size page 13 / 39

14 3) will be used for all females and 8mm ID ETT loaded in the blue Airtraq (size 4) will be used for all males. The ETT channel of the page 14 / 39

15 Airtraq will be generously lubricated and appropriate ETT will be placed in it. Both convex and concave surfaces of the Airtraq blade page 15 / 39

16 will also be lubricated. TECHNIQUE OF INSERTING AIRTRAQ : Patient will be lying supine page 16 / 39

17 with head in sniffing position. In all patients observer 2 will insert the Airtraq into the mouth in the midline over the centre of the tongue page 17 / 39

18 while providing a jaw lift with the thumb of the observer s non dominant hand hooked over the patient s mandible, intra-orally. page 18 / 39

19 This would be the primary and preferred technique. If insertion of the Airtraq is found to be difficult with the primary technique, the page 19 / 39

20 following manoeuvres may be employed, in descending order of preference: page 20 / 39

21 (i)jaw thrust provided by another anaesthesiologist from the patient s foot end. page 21 / 39

22 (ii)insertion of the Airtraq from the side of the mouth. Manoeuvres employed for Airtraq insertion will be noted. Once page 22 / 39

23 insertion is achieved, the Airtraq blade wll be advanced along the posterior wall of the pharynx until its tip is positioned in the vallecula. page 23 / 39

24 It will then be lifted up to obtain a glottic view. If a back and up manoeuvre (manoeuvre1) as recommended by the manufacturers page 24 / 39

25 fails to produce a good glottis view, the epiglottis will be included with the Airtraq (manoeuvre2) to obtain a central grade I/II view, and if page 25 / 39

26 this fails, external laryngeal manipulation will be employed in addition (manoeuvre3). The time (T1) and manoeuvres require to obtain a page 26 / 39

27 good glottic view will be noted. If despite using all three manoeuvres, a grade I/II view is not obtained, the patient will not be page 27 / 39

28 excluded from the study. Once a good glottic view is obtainedpage 28 / 39

29 1) In group A the ETT will be advanced into the glottis under vision.the ETT will be displaced laterally from the Airtraq, and the Airtraq page 29 / 39

30 removed while the ETT cuff is inflated and positive pressure ventilation (PPV) initiated. The time taken from the visualization of page 30 / 39

31 the glottis till a capnographic trace is obtained will be noted (T2). 2) In group AB, after visualisation of glottis the bougie will be page 31 / 39

32 advanced through the glottis first. Once this is achieved, the ETT will be railroaded over the bougie into the trachea, under vision. The page 32 / 39

33 bougie and the Airtraq will then be withdrawn, while the ETT cuff is inflated and PPV initiated. T2 will be noted as above. page 33 / 39

34 In both groups, the ETT will be secured after confirming bilaterally equal normal breath sounds. page 34 / 39

35 Ease of intubation will be graded by observer 2 as below: Easy: Smooth insertion of Airtraq into position in the vallecula page 35 / 39

36 allowing a good glottic view AND smooth passage of ETT/GEB into the glottis without hinging against arytenoids page 36 / 39

37 Not very easy: Difficulty in inserting Airtraq into position and obtaining good glottic view OR hinging of ETT/GEB against page 37 / 39

38 arytenoids. Difficult: Difficulty in inserting Airtraq into position AND difficulty in page 38 / 39

39 Powered by TCPDF ( PDF of Trial inserting ETT/GEB through the vocal cords OR complete inability /failure to intubate by using Airtraq.. page 39 / 39