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CTRI Number  CTRI/2014/07/004763 [Registered on: 25/07/2014] Trial Registered Retrospectively
Last Modified On: 17/06/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
Evaluation of two type of instrument used by anesthesiologists to place preshaped tubes into the windpipe of patients under anesthesia.  
Scientific Title of Study   Prospective randomized trial to evaluate role of McGrath MAC videolaryngoscope in placement of double lumen tubes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumitra G Bakshi 
Designation  Assoc Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical Care and Pain Tata Memorial Hospital, Mumbai, India

Mumbai
MAHARASHTRA
400028
India 
Phone  022-24177058  
Fax    
Email  sumitrabakshi@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajay Gawri 
Designation  P.G.Student  
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical Care and Pain Tata Memorial Hospital, Mumbai, India

Mumbai
MAHARASHTRA
400028
India 
Phone  022-24177058  
Fax    
Email  drajaygawri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumitra G Bakshi 
Designation  Assoc Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical Care and Pain Tata Memorial Hospital, Mumbai, India

Mumbai
MAHARASHTRA
400028
India 
Phone  022-24177058  
Fax    
Email  sumitrabakshi@yahoo.in  
 
Source of Monetary or Material Support  
Tata Memorial Hospital. 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Borges Road , Parel, Mumbai -400012. India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumitra Bakshi  Main OT complex, 2nd floor , Main Building   Tata Memorial Hospital Borges Road, Parel Mumbai -12 India
Mumbai
MAHARASHTRA 
022-24177058

sumitrabakshi@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA grade I-II Patients planned for surgery needing lung isolation technique with predicted normal airways,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Equipment,MacIntosh Laryngoscope,  Intubation time to be compared  
Comparator Agent  Equipment- McGrath blade  Intubation time to be compared 
Intervention  No new inteervention planned in the study. Intubation is the only intervention and is a part of routine anesthetic management.   All patients planned for general anesthesia needing intubation with double lumen tube.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Informed consent agreed upon
2. ASA physical status I and II patients
3. Age > 18years
4. Scheduled to undergo elective surgical procedures requiring DLT
 
 
ExclusionCriteria 
Details  1. Refusal to consent
2. ASA physical status III and above
3. A history or Anticipated difficult airway on clinical examination
(includes MPC III and IV, Thyromental distance less than 6.5cm, Sternomental distance less than 12.5cm, interincisor gap of less than 3cm,BMI 30)
4 The presence of indications for rapid sequence induction of anesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Objective: To prove that the ‘Time To Intubate (TTI)’ the trachea with DLT using McGrath videoscope is similar to that with MacIntosh laryngoscope, with an accepted difference of 20 sec (non inferiority study design)

 
After induction of anesthesia, the muscle relaxant will be adminstered . After 4 minutes intubation will be attempted. Time from passage of scope to first capnograph deflection is the Time to intubate (TTI) comparision between the TTI of two scopes is the primary endpoint.  
 
Secondary Outcome  
Outcome  TimePoints 
Is there any difference in the numbers of failures between the scopes?
2. What are the complications that are encountered with either scope?
3. How easy is it to intubate using the two scopes on the basis of NRS Score- 1(extremely easy)- 10 (extremely difficult ).?
 
Sore throat and hoarseness will be evaluated 12-24 hours after surgery.  
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/06/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

After informed consent, we will recruit 74 adult ASA Gr I-II patients who are scheduled for elective open thoracic surgery requiring double-lumen tube insertion for one-lung ventilation.

 

Pre-operative airway assessment and the Mallampati score, inter-incisor gap and thyromental distance will be documented.

 

Using computer-generated tables, patient will be randomized to anaesthesiologists ( predefined 4-5 anesthesiologists) experienced with McGrath in addition to standard blade.  Previous six successful intubations in patients with single lumen tube will be considered as the criteria to label the anaesthesiologist experienced with McGrath scope.

 

 The intubator will have to use either the standard MacIntosh scope (blade 3) or the McGrath videoscope, based on randomization which will be concealed using sealed opaque envelopes. It will be ensured at the being of the trial that each intubator does near equal intubation with each scope. Randomization, thus,  will be done at two levels , intubator and scope.   

 

After attaching appropriate monitors and checklist, the patients’ lungs will be pre-oxygenated with 100% oxygen at a fresh gas flow of 6 litres/min for 3 minutes via a closely applied facemask. General anaesthesia will then be administered with intravenous fentanyl 2 microgram/kg followed by intravenous propofol 2-3 mg/kg or any other suitable induction agent.  After loss of consciousness, Injection rocuronium 1 mg/kg or other suitable relaxant will be administered and manual bag  â„ mask ventilation will be continued for 3 min. The appropriate double-lumen tube (size and side) will be inserted as clinically indicated. The tube will be lubricated well. The anaesthetist will insert the McGrath blade along the midline of the tongue as per standard recommendations. Once the glottis is seen clearly on the screen, a double lumen tube will be inserted into the patient’s mouth from the right side. When the distal tip of the tube will be seen to enter the trachea between the vocal cords, the stylet will be removed and the tube will be rotated 90 degrees under observation on the videoscope screen, either clockwise or anti-clockwise depending on the type of tube. The double-lumen tube will then be advanced and the blade removed from the patient’s mouth. Using the Macintosh laryngoscope blade, the tube will be inserted in the traditional fashion. Immediately after successful intubation, an assistant will inflate both cuffs with air and mechanical ventilation will commence. Correct positioning of the double-lumen tube will be determined clinically by auscultation of both lungs before and after selective clamping of the tracheal and bronchial lumens, and with a fibre optic bronchoscope to be inserted with the patient in the supine position.

 

Time taken for visualization of cord, defined as time from advancement of scope from dental arches to visualization of the glottis and the total time to intubate, defined as time from advancement of scope from dental arches to deflection of capnograph for each laryngoscope will be recorded.

 

A failed intubation is defined when the user cannot intubate the patient’s trachea after two attempts, each attempt being defined as not more than 120 seconds or fall of saturation to 90% whichever is earliest. A total of two attempts will be allowed to each performer. In between each attempt patient will be masked ventilated.

 

In case of failure to intubate after two attempts, with McGrath scope, intubation can be tried with standard MacIntosh blade. Any difficulty at intubation or mask ventilation at any point of time, the airway will be managed as per ASA difficult airway guidelines.

 

In such cases, the time to intubate will be taken as the addition of duration of each intubation attempt. However, cases in which intubation has failed twice, the time to intubate will not be considered in the analysis with respect to intubation time. The event will be recorded as a failure.

 

The performers are permitted to use external laryngeal pressure to improve the glottic view or to facilitate tube insertion. This would be recorded in the case form as an optimization manoeuvre.

 

However in case if the attempt has to be abandoned in view of an inappropriately sized DLT, the event will be recorded but the attempt and time will not be considered in the TTI for that patient.

 

In case of a mechanical damage to tube like tears of the tracheal or bronchial cuff, then a new double lumen tube will be inserted, and it will be recorded as a complication.

 

 

Once tube is in place, the placement of the tube will be confirmed and any alteration needed will be noted.

 

 

The injury i.e. visible trauma to lip or oral mucosa, presence of blood on laryngoscope blade will be recorded as minor injury. While, any bleeding requiring intervention in the form of packing or suturing or dental extraction of a previous normal tooth will be graded as major injury

 

 

Once tracheal intubation is accomplished successfully, the performer will score the glottic view as per Cornmack and Lehane grading and also score the ease of use of the laryngoscope on a numerical rating scale (NRS) (ranging from 1 for extremely easy to 10 for extremely difficult).

 

 The lowest value of arterial oxygen saturation, pre-intubation and  post-intubation blood pressure readings will be noted at 1,2,5 min

 

Presence of bronchospasm( wheeze on auscultation) will be noted.

 

Following surgery, the patient will be evaluated in the post anesthesia care unit for symptoms of sore throat and hoarseness on a scale of 0 (no hoarseness) - 10 (significant hoarseness). For analysis, the score will be clubbed as 0- nil, 1-3 mild, 4-6=moderate, 7-10= severe

    

 

 
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