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CTRI Number  CTRI/2017/09/009656 [Registered on: 05/09/2017] Trial Registered Retrospectively
Last Modified On: 24/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the ease of insertion of a special breathing tube called Double Lumen tube using laryngoscope with a video relay or a classic non video laryngoscope for the purpose of general anaesthesia to facilitate lung surgeries 
Scientific Title of Study   A Randomized Control Study to compare CMAC D Blade video laryngoscope with Macintosh laryngoscope for insertion of double lumen tube in patients undergoing thoracotomy for One Lung Ventilation.
 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Roy Rajan Mathai 
Designation  PG Resident  
Affiliation  Christian Medical College- Dr. MGR Medical University 
Address  Department of Anaesthesiology, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8940147334  
Fax    
Email  royrajan.m@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Raj Sahajanandan 
Designation  Professor 
Affiliation  Christian Medical College- Dr. MGR Medical University 
Address  Department of Anaesthesiology, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8489622336  
Fax  04162282105  
Email  rajsahajanandan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Roy Rajan Mathai 
Designation  PG Resident  
Affiliation  Christian Medical College- Dr. MGR Medical University 
Address  Department of Anaesthesiology, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8940147334  
Fax    
Email  royrajan.m@gmail.com  
 
Source of Monetary or Material Support  
Institutional Fluid Research Grant, Office of Research, Christian Medical College, Vellore, Tamil Nadu. PIN - 632002. 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Christian Medical College, Vellore, Tamil Nadu, India. PIN - 632004. 
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 
Roy Rajan Mathai  Cardiothoracic Vascular Operating Room  Cardiothoracic Vascular Operating Room, Christian Medical College, Vellore-632004
Vellore
TAMIL NADU 
8940147334

royrajan.m@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Silver, Christian Medical College- Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing thoracotomy and who require one lung ventilation with double lumen tube,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CMAC D Blade video laryngoscope  The video laryngoscope blade is made available before induction of anaesthesia and the intubation performed with its use and the timer is noted. 
Intervention  Macintosh laryngoscope blade   The randomisation envelopes are opened before induction of anaesthesia and the equipment needed is made available. Double lumen tube with stylet is made available. The timer is instituted before the introduction of macintosh laryngoscope into the oral cavity and stopped after three capnographic cycles are visualised.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing Thoracotomy surgeries with the aid of Double Lumen Tube
ASA 1 & 2
Patients with EL GANZDOURI Risk scoring less than or equal to 4 
 
ExclusionCriteria 
Details  Restricted mouth opening <2.5 CM
ASA III AND IV
Non consenting 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Intubation Time for the double lumen tube using either CMAC D BLade or Macintosh laryngoscope.   Intubation Time is referred to as the time in seconds from the introduction of the laryngoscope blade through the oral cavity to the successful completion of intubation.i.e. visualisation of three capnographic cycles.  
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamic response (Heart rate, blood pressure and mean arterial pressure) to intubation in both groups.   Values will be recorded at pre-induction, 1 minute, 3 and 5 minutes after induction 
To assess Intubation difficulty scale in both groups.

 
Recognized grading system which consists of seven variables the recording of which is done by the anesthetist intubating the patient. 
To compare the incidence of complications in both groups.  
Airway injuries will examined by a separate anesthetist in the theatre . Post-operative complications like hoarseness of voice and sore throat are examined by an independent observer. Oesophageal intubation will also be noted if occurred.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/05/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="23" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

BACKGROUND: 

Laryngoscopy is a procedure by which a tube is placed into the windpipe of a person for breathing during general anesthesia to facilitate surgery, abolish anxiety, memory and provide immobility for surgery, this is generally done by the use of a Macintosh laryngoscope. In our institution, we use double lumen tubes for certain thoracic surgeries as we need to isolate/collapse one of the lungs so that the surgeon has a better view of the operating site and also provide them ease for surgical dissection. These Double lumen tubes are bigger in diameter, rigid in structure and longer than a normal tube that we place into the wind pipe. Due to their larger size, the insertion of these are difficult even in patients with normal airway anatomy and is challenging to anesthetists. Thus complications are more due to its insertion like airway trauma, sore throat, postoperative hoarseness especially when the view of the glottis is not complete during direct laryngoscopy. The potential advantages of the use of a video laryngoscope include a better view of the cords, close view of the double lumen tubes when it passes the vocal cords, assists the staff providing external laryngeal pressure and also the external monitor can be a teaching tool. Studies have also shown that the video laryngoscope can result in less use of force required for laryngoscopy. This may result in less intubation response and hence fewer complications. This CMAC D Blade video laryngoscope has been used in difficult airway scenarios in our institution.In our study we are comparing two different laryngoscopes for tube insertion; a new type of video laryngoscope and the traditional Macintosh laryngoscope and try to compare which scope is better for Double lumen tube insertion. 


AIM: 

Primary aim: To compare the time taken for successful intubation for a double lumen tube with CMAC video laryngoscope and Macintosh laryngoscope.

Secondary aims: 1) To compare the hemodynamic response to intubation in both groups.

                            2) To assess Intubation difficulty scale in both groups.

                            3) To compare the incidence of complications in both groups.

DESIGN: a Randomized control study.

METHODS:

The aim of the study is to compare Direct Laryngoscopy with Macintosh (MAC#3) blade versus CMAC D blade video laryngoscope for intubation with a double lumen tube.Eighty patients who are posted for elective thoracic surgery who if consent for the study will be randomly divided into either group A (CMAC) or group B(Macintosh).Airway assessment will be done preoperatively for all patients by looking at their Mallampatti grade, Neck extension, Mouth opening, Jaw movement, Thyromental distance, Previous failed intubations and assessing them for any pathologies associated with the difficult airway.The risk will be assessed using a standardized scoring system which is the  El Ganzdouri Risk Index for difficult tracheal intubation(EGRI).A score less than or equal to 4 is taken as less likely to be a difficult intubation. If the patient has difficult airway they will not be included in the study.Eighty patients with no anticipated difficult airway will be recruited and informed consent will be taken.The anesthetist who has significant experience with both scopes and DLT will do the intubation.(Experience is defined as any anesthetist who has experience of putting more than 10 Double lumen tubes and who has used both scopes more than 10 times on an intubating manikin and 5 times in patients). Randomization will be computer generated and will be informed to the anesthetist just before induction of anesthesia.The patient will be pre oxygenated (etO2 >85), anesthesia induced with adequate standard doses of propofol, fentanyl and muscle relaxant of choice.Adequacy of muscle relaxation will be ensured by using a TOF watch and getting a TOF ratio of zero. An appropriate size Double lumen tube will be chosen as per the routine guidelines for our institution. After induction, a pre-curved double lumen tube is to be inserted with either of the scopes.A successful intubation will be confirmed by 3 capnographic cycles and bilateral chest auscultation.Time taken for intubation is defined as the time from introduction of the scope till 3 complete capnographic cycles.The position of the tube is confirmed by fiber optic bronchoscope.An independent observer (an instrument technician) will measure the time taken for successful intubation. He will also document the use of additional maneuvers or laryngeal pressure applied. Another anesthetist in the theatre will then examine the oral cavity, pharynx, and larynx using the laryngoscope for any airway trauma.Hemodynamic response (Heart Rate, Blood Pressure, and MAP) to intubation will be monitored at 0(baseline),1 min,3 min, and 5 min.Post operatively an independent observer will look for hoarseness of voice and sore throat. The data will be entered into the epidata software and will be analyzed for the results. 

 
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