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CTRI Number  CTRI/2024/01/061818 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare the efficacy of placement of airway tube in windpipe between direct visualization of larynx by using McCoy blade and indirect visualization of larynx by using video laryngoscope in patients who are scheduled for cervical spine surgery. 
Scientific Title of Study   Comparison of direct laryngoscopy with McCoy blade & BPL video laryngoscopy for intubation in patients undergoing elective cervical spine surgery. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohammad Aleem Ansari 
Designation  Junior resident 
Affiliation  Uttar Pradesh university of medical sciences Saifai Etawah 
Address  Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  8750843632  
Fax    
Email  medico398@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atit Kumar 
Designation  Junior grade Professor 
Affiliation  Uttar Pradesh university of medical sciences Saifai Etawah 
Address  Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9453471671  
Fax    
Email  dr_atit@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Atit Kumar 
Designation  Junior grade Professor 
Affiliation  Uttar Pradesh university of medical sciences Saifai Etawah 
Address  Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah

Etawah
UTTAR PRADESH
206130
India 
Phone  9453471671  
Fax    
Email  dr_atit@rediffmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh university of medical sciences Saifai Etawah 
 
Primary Sponsor  
Name  Uttar Pradesh university of medical sciences Saifai Etawah 
Address  Uttar Pradesh university of medical sciences Saifai Etawah Uttar Pradesh India PIN code 206130 
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 Mohammad Aleem Ansari  Uttar Pradesh university of medical sciences  Department of anesthesiology and critical care Etawah Uttar Pradesh
Etawah
UTTAR PRADESH 
8750843632

medico398@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES SAIFAI ETAWAH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S129||Fracture of neck, unspecified, (2) ICD-10 Condition: Q069||Congenital malformation of spinalcord, unspecified, (3) ICD-10 Condition: G952||Other and unspecified cord compression, (4) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BPL video laryngoscopy  In this group video laryngoscopy will be performed by using the BPL video laryngoscope after giving premedication, induction agent and muscle relaxant. Duration of intubation of endotracheal tube into the trachea from handling of video laryngoscopy to appearance of capnogram on monitor will be noted and other parameters like Modified Cormack Lehane grading, ease of intubation and hemodynamic parameters for 10 minutes will also be monitored. 
Comparator Agent  Direct laryngoscopy with McCoy blade  In this group direct laryngoscopy will be performed by using the McCoy blade after giving premedication, induction agent and muscle relaxant. Duration of intubation of endotracheal tube into the trachea from handling of direct laryngoscope with McCoy blade to appearance of capnogram on monitor will be noted and other parameters like Modified Cormack Lehane grading, ease of intubation and hemodynamic variability for 10 minutes will also be monitored. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Conscious with cervical spine unstable patients
2.Age 18 years to 65 years
3.ASA class 1 and ASA class 
 
ExclusionCriteria 
Details  1.Known history of difficult intubation
2.Mouth opening less than 3 fingers
3.Thyromental distance less than 6.5 centimeter
4.Body mass index more than 35 kg-m2
5.Known risk of aspiration,
6.Failed intubation in unanticipated difficult airway. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the duration of the tracheal intubation procedure in BPL video laryngoscopy and Direct laryngoscopy with McCoy blade.
 
90 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the visualization of airway between the two groups using Modified Cormack Lehane grading
2.Ease of intubation
3.To determine intubation difficulty score
4.To compare the hemodynamic stability while the insertion of endotracheal tube into trachea 
10 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   27/01/2024 
Date of Study Completion (India) 30/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Intubating the trachea and securing the airway remains a challenge, although it is a routine practice for the anesthesiologist. There is no single factor to predict the existence of a difficult airway, so difficult airway is not recognized until the induction of anesthesia. Difficult intubation is very subjective and it is difficult to measure the degree of difficulty, as previous studies say that in difficult airway management video laryngoscope improve Cormack- Lehane grade and achieve the same or a higher intubation success rate in less time, compared with direct laryngoscope. After getting clearance from ethical committee, to refine the previous studies we are conducting a study on 60 patients of elective cervical spine surgery and the patients are divided in two groups by random number table with 30 patients in each group, to compare efficacy of BPL video laryngoscopy and direct laryngoscopy with McCoy blade for intubation in patients undergoing elective cervical spine surgery. Patients will be intubated by using BPL video laryngoscope and direct laryngoscope with McCoy blade of respective group patients after giving premedication, preoxygenation for 3 minutes, induction agent and muscle relaxants. The primary objective is to find duration of the tracheal intubation by using BPL video laryngoscope and direct laryngoscope with McCoy blade. The secondary objectives are comparing the visualization of airway between the two groups using Modified Cormack Lehane grading, ease of intubation, to determine intubation difficulty score, to compare the hemodynamic stability while and after insertion of ET Tube into trachea.


 
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