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CTRI Number  CTRI/2020/05/024961 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On: 30/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal Crossover Study 
Study Design  Other 
Public Title of Study   A study to compare two laryngoscopes, Macintosh and Airtraq to evaluate the movements of cervical spine while intubating. 
Scientific Title of Study   A comparative study to evaluate the cervical spine movements during laryngoscopy using Macintosh and Airtraq laryngoscopes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiranpreet Kaur 
Designation  Associate Professor 
Affiliation  Pt.B.D.Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9992249436  
Fax    
Email  kiranpreet72@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rameez Raja 
Designation  Junior resident 
Affiliation  Pt. B.D. Sharma PGIMS 
Address  Doctors Hostel, Department of Anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9597173094  
Fax    
Email  rameezonline@live.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rameez Raja 
Designation  Junior resident 
Affiliation  Pt. B.D. Sharma PGIMS 
Address  Doctors Hostel, Department of Anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak.

Rohtak
HARYANA
124001
India 
Phone  9597173094  
Fax    
Email  rameezonline@live.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and critical care Pt. B.D. Sharma PGIMS, Rohtak. Haryana 124001  
 
Primary Sponsor  
Name  Department of Anaesthesiology and critical care 
Address  Pt. B.D. Sharma PGIMS, Rohtak. Haryana 124001 
Type of Sponsor  Government medical college 
 
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 Kiranpreet Kaur   Pt. B.D. Sharma PGIMS, Rohtak  Department of Anaesthesiology and critical care, Pt. B.D. Sharma PGIMS, Rohtak Haryana 124001
Rohtak
HARYANA 
9992249436

kiranpreet72@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Pt. B.D. Sharma PGIMS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AirTraq laryngoscope  Patient will be ventilated again with 100 % oxygen using bag and mask for another 4-5 breaths. Second laryngoscopy using Airtraq laryngoscope will be done and third image of lateral cervical spine radiograph will be taken. Radiograph during both the laryngoscopies will be taken only after obtaining best laryngoscopic view and the laryngeal view will be graded based on modified Cormack and Lehane criteria and laryngoscopy time will be noted. 
Comparator Agent  Macintosh laryngoscope  Intravenous line will be secured with appropriate sized intravenous cannula. Induction of anaesthesia will be done with injection thiopentone 5 mgkg-1, fentanyl 2 µgkg-1 and vecuronium bromide 0.1 mgkg-1 intravenously. Intermittent positive pressure ventilation will be done for 3 minutes. Laryngoscopy will be first performed using Macintosh laryngoscope and second X-Ray image of lateral cervical spine will be taken and the laryngeal view will be graded based on modified Cormack and Lehane criteria and laryngoscopy time will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients aged between 18-60 years of either sex, belonging to American Society of Anesthesiologists (ASA) physical status I or II scheduled for elective surgery under image control requiring general anaesthesia and intubation will be enrolled in the study. 
 
ExclusionCriteria 
Details  Patients having cervical spine injury, Rheumatoid Arthritis, Scoliosis/ spinal deformity, anticipated difficult intubation, aspiration risk, pregnancy, BMI > 30kgm-2 will be excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Analysis of radioimages: Atlanto occipital distance, difference between the angles made by the cervical spine, Anterior deviation of the spine, Soft tissue displacement will be measured.
The following will be assessed for both Macintosh and Airtraq laryngoscopes.Data will be compiled and appropriate statistical test will be used to analyze the results.
 
The outcome will be assessed on Day 1 of the study. It takes 30 mins to record the data and 1 week to analyze the data. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Laryngocopic time
2. Cormack Lehanne grading
3. Hemodynmic parameters
The following will be assessed for both Macintosh and Airtraq laryngoscopes.Data will be compiled and appropriate statistical test will be used to analyze the results. 
The outcome will be assessed on Day 1 of the study. It takes 30 mins to record the data and 1 week to analyze the data. 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   N/A 
Date of First Enrollment (India)   03/05/2020 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The present prospective study will be conducted in Department of Anaesthesiology & Critical care, Pt. B.D. Sharma, PGIMS, Rohtak. A total of 25 patients, between age group of 18-60 years belonging to ASA grade I and II, scheduled for elective surgery under image control requiring general anaesthesia and intubation, will be enrolled in the study. Patients with cervical spine injury, Rheumatoid Arthritis, Scoliosis/ spinal deformity, anticipated difficult intubation, aspiration risk, pregnancy, BMI > 30kg/m2 will be excluded from the study. On arrival in the operation theatre baseline readings of electrocardiography (ECG), pulse oximetry (SPO2)), non-invasive blood pressure (NIBP) will be recorded. Baseline image of lateral view of cervical spine including first 4 cervical vertebrae will be taken. First laryngoscopy was performed using Macintosh laryngoscope and second X-Ray image of lateral cervical spine was taken. Second laryngoscopy was done using Airtraq laryngoscope and third image of cervical spine radiograph will be taken. Simultaneously the laryngeal view based on modified Cormack and Lehane criteria and laryngoscopy time will be noted using both the laryngoscopes. All the three radiographs were analysed and angle measurements from C0-C4 will be done to evaluate the cervical spine movement. In addition, Atlanto-occipital distance, anterior deviation of spine and soft tissue displacement during laryngoscopy, was also calculated from radiographs. MAP, HR and SpO2 will be recorded before induction and immediately after both laryngoscopies.


 
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