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CTRI Number  CTRI/2020/11/028984 [Registered on: 09/11/2020] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Other (Specify) [Airtraq DL]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 2 types of laryngoscopes (Airtraq and Mcintosh) for inserting double lume endotracheal tubes(A special type of endotracheal tube used in lung surgeries for oxygenation during anaesthesia)in airways which are intentionally made difficult 
Scientific Title of Study   Comparison of Airtraq and Mc intosh laryngoscope for double lumen tube intubation in simulated difficult airway.- A randomised study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Mounika 
Designation  Post graduate student 
Affiliation  Nizams institute of Medical sciences 
Address  Staff Anaesthesia room,Millenium Block cardiothoracic surgery operation theatre ,Department of Anaesthesia, Nizams institute of Medical sciences Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  2018mounika.k@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prachi Kar 
Designation  Associate Professor 
Affiliation  Nizams institute of Medical sciences 
Address  Staff Anaesthesia room, Millenium Block Cardiothoracic surgery operation theatre,Department of Anaesthesia, Nizams institute of Medical sciences Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  7702897765  
Fax    
Email  prachikar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  K Mounika 
Designation  Post graduate student 
Affiliation  Nizams institute of Medical sciences 
Address  Staff Anaesthesia room, Millenium Block Cardiothoracic surgery Operation Theatre,Department of Anaesthesia, Nizams institute of Medical sciences Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  2018mounika.k@gmail.com  
 
Source of Monetary or Material Support  
Nizams institute of Medical sciences, Hyderabad, Telangana 
 
Primary Sponsor  
Name  K Mounika 
Address  Department of Anaesthesia Nizams Institute of Medical Sciences, Hyderabad 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Prachi Kar  Associate Professor, Nizams Institute of Medical Sciences, Hyderabad 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
K Mounika  Nizams institute of medical sciences  Staff Anaesthesia room, Millenium Block Cardiothoracic surgery Operation Theatre. Depart of Anaesthesia
Hyderabad
TELANGANA 
8885283618

2018mounika.k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airtraq laryngoscope  Airtraq Dl laryngoscope for Double lumen tube insertion in simulated difficult airway. 
Comparator Agent  Mc Intosh Laryngoscope  Mc Intosh Laryngoscope for Double lumen tube insertion in simulated difficult airway 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I or II, Age 18 - 60 years, both sex, patients with normal airway parameters 
 
ExclusionCriteria 
Details  Anticipated difficult intubation or difficult mask ventilation parameters
Patients with large thyroid mass or other neck masses
C-spine fracture or other cervical disorders with restricted neck movement or unstable cervical spine
faciomaxillary injury or anomalies, Abnormalities of airway like burn contractures and cleft lip/palate
TMJ ankyloses
patient with bleeding disorders
uncontrolled hypertension,
Actively secreting adrenal tumours, or cardiac disorders where hemodynamic response to intubation may not be well tolerated
BMI>30
Pregnant females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time required for DLT insertion  Time required for DLT insertion 
 
Secondary Outcome  
Outcome  TimePoints 
1. The number of attempts at intubations and failures if any
2. Cormack Lehanne grade and Intubation difficulty score
3. Ease of laryngoscopy and ease of intubation on 4-point Likert scale
4. The incidence of complications like trauma, desaturation, cuff rupture and postoperative sore throat
5- Hemodynamic response to intubation 
hemodynamic response at 1,2 and 5 minutes after intubation
compliationsafter intubation and in post operative period 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2020 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   after study completion 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Written informed consent will be obtained from the subjects recruited for this single blinded randomised study. Patient’s age, height, weight, ASA/NYHA status, diagnosis, surgery, co morbidities and airway parameters {(Inter incisor gap (IID), Mentohyoid distance (MHD), Thyromental distance (TMD), Sternomental distance (SMD), Malampatti grading (MPG)  } will be noted preoperatively. 52 patients with expected normal airway parameters will be randomly allocated to either the Airtraq or Macintosh group (group A and group M respectively), using computer generated randomisation chart . The patients will be premeditated with alprazolam 0.25 mg a night before the surgery and will be asked to follow NPO (Nil per oral) orders for 8h. After shifting the patients to the operating room, ASA standard monitoring along with entropy will be connected, 18G intravenous line will be placed and intravenous fluid will be started. Under strict aseptic precautions and local anaesthesia, radial artery will be cannulated with 20 G switch canula and arterial pressure will be monitored. Baseline mean arterial pressure (MAP), heart rate (HR), SpO2 values will be noted. Epidural space will be identified in T4-5/T5-6 interspace using 18G Tuohy needle with loss of resistance to air technique, epidural catheter will be inserted and test dose of 3ml, 2% lignocaine will be injected to rule out intrathecal position. Patients will be made to lie down in supine position with neutral neck position using a pad under the occiput and Philadelphia rigid cervical collar of appropriate size will be applied. Inter- incisor distance will be measured after collar application. Patients will be excluded if IID is <2 cm after collar application. The height of the operating table will be adjusted such that the plane of the patient’s face is at the level of xiphisternum of the anaesthesiologist performing laryngoscopy and intubation.  Patients will be preoxygenated with 100 % Oxygen for 3 minutes followed by premedication with injection fentanyl 2ug/kg. Induction will be achieved with graded dose of propofol to achieve entropy of 40-60. After confirming ability to ventilate, inj. Rocuronium 1mg/kg will be administered and mask ventilation will be continued for one minute. At this point the sealed envelope containing the group allocation will be opened and the allocated laryngoscope will be made ready. In case of Airtraq, the stilette of DLT will be removed and the DLT will be preloaded into the integrated channel of Airtraq DL (ProdolMeditec S.A., Vizcaya, Spain) as per manufacturer instructions. Universal phone adapter will be used during intubation with Airtraq. The decision on the size of DLT to be used will be at the discretion of attending anaesthesiologist. The size of DLT used will be noted.  During laryngoscopy the time to best glottic view will be noted. This will defined as time from beginning of laryngoscopy to obtain the best view of the vocal cords. Laryngoscopic view will  be graded using Cormack lehane (CL) grading system  and CL grade will be noted. Total time for intubation will be noted. This will be defined as time from beginning of laryngoscopy till successful completion of intubation. The length at which DLT is to be fixed at angle of mouth will be decided based on height-based formula {(height in cm /10) + 12} being approximated to nearest whole number. After placement of tube and inflation of cuff, the adequacy of isolation will be checked by auscultation.  In patients where a failure to intubate or achieve isolation is encountered, Philadelphia collar will be removed and routine intubation practice will be followed for placement of DLT. Other parameters such as number of attempts, manoeuvres used for intubation, intubation difficulty according to intubation difficulty score (IDS) will be noted.  The hemodynamic response to intubation (MAP and HR) at 1, 2 and 5 minutes after intubation will be noted. The ease of laryngoscopy and ease of tube placement will be noted on a 4-point Likert scale. Complications like oropharyngeal trauma, cuff rupture, desaturation will be noted. The patients will be followed up on the incidence of postoperative hoarseness.

 
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