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CTRI Number  CTRI/2024/02/062678 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparison between 2 videolaryngoscopes, Kingvision and VL3R (Hugemed) in patients posted for electiv surgery under general anaesthesia 
Scientific Title of Study   A comparative study of Kingvision and VL3R (Hugemed)tm videolaryngoscope for the ease of intubation in adult patients undergoing general anaesthesia for elective 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  Trisha Kshirsagar 
Designation  Second year junior resident 
Affiliation  Jawaharlal Nehru Medical College, Aligarh 
Address  Department of Anaesthesiology, Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  9960072243  
Fax    
Email  trishakshirsagar99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Syed Kamran Habib 
Designation  Assistant professor 
Affiliation  Jawaharlal Nehru Medical College, Aligarh 
Address  Department of anesthesia, Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh, Uttar Pradesh

Aligarh
UTTAR PRADESH
202001
India 
Phone  9897172780  
Fax    
Email  syedkamranhabib@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Syed Kamran Habib 
Designation  Assistant professor 
Affiliation  Jawaharlal Nehru Medical College, Aligarh 
Address  Department of anesthesia, Jawaharlal Nehru Medical college, Aligarh Muslim University, Aligarh, Uttar Pradesh

Aligarh
UTTAR PRADESH
202001
India 
Phone  9897172780  
Fax    
Email  syedkamranhabib@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru medical college, Aligarh Muslim University, ALigarh 
 
Primary Sponsor  
Name  JNMC hospital, Aligarh 
Address  Aligarh 
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 Trisha Kshirsagar  JNMC hospital  Department of Anaesthesiology, faculty of medicine, Aligarh Muslim University
Aligarh
UTTAR PRADESH 
9960072243

trishakshirsagar99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Comparator Agent  Intubation using Kingvision Videolaryngoscope  Patients will be premedicated with IV Inj. Ondansetron 0.1 mg/kg, IV Inj. Fentanyl 1.5 mcg/Kg and IV Inj. Midazolam 30mcg/Kg IV and preoxygenation will be carried out using 100% oxygen using closed circuit with 10 litres of total gas flow. After premedication, Heart rate and Blood pressure will be recorded as prior to intubation values. All patients will be given IV Inj. Propofol 2 mg/kg for induction of anaesthesia until loss of consciousness. IV Inj Succinylcholine 1.5 mg/kg IV as intubating muscle relaxant will be administered after loss of verbal contact and after demonstrable mask ventilation. After adequate muscle relaxation, intubation shall be carried out using Kingvision videolaryngoscope, and parameters will be recorded 
Intervention  Intubation using VL3R (Hugemed) Videolaryngoscope  Investigator will pick the envelope with the name of one videolaryngoscope prior to premedication. Patients will be premedicated and preoxygenation will be carried out using 100% oxygen with 10 litres of total gas flow. Heart rate and Blood pressure will be recorded as prior to intubation values. All patients will be given IV Inj. Propofol 2 mg/kg for induction of anaesthesia until loss of consciousness. IV Inj Succinylcholine 1.5 mg/kg IV as intubating muscle relaxant will be administered after loss of verbal contact and after demonstrable mask ventilation. After adequate muscle relaxation, intubation shall be carried out using VL3R videolaryngoscope and parameters will be recorded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Written and well informed consent.

2. ASA grade I-II of either sex.

3. All Mallampatti grades.

4. Age between 18-60 years.

5. Weight between 45-70 Kg.

 
 
ExclusionCriteria 
Details  1.ASA grade III and IV
2. Previous failed intubations
3. Head and neck surgery
4. Pregnancy
5. Inter incisor distance less than 3 cm
6. Risk of gastric regurgitation ( full stomach, hiatus hernia)
7. Raised ICP or cervical spine injury
 
 
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 
To compare the time for successful intubation for both the devices  at first capnograph reading 
 
Secondary Outcome  
Outcome  TimePoints 
Change in haemodynamic parameters   pre insertion, immediately post insertion, 3 minutes, 5 minutes, 10 minutes 
Ease of intubation  At end of intubation 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   04/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Video assisted laryngoscope have a monitor that allows physicians to secure the airway under vision and additionally capture pictures and videos in real time, Indirect visualization of the laryngeal inlet provided by the newly designed video assisted laryngoscope facilitates tracheal intubation .

 

To obtain optimal visualisation of the glottis, direct laryngoscopy requires alignment of the oropharyngeal-laryngeal axes. However, duration of intubation and the success rate for securing the airway by tracheal intubation might have a significant impact on undesirable events like hypoxia or regurgitation. It can sometimes be challenging to place an endotracheal tube (ETT) in front of the glottis and advance it despite good visualization on the monitor, especially when a video laryngoscope (VL) with a hyper-angulated blade is used. This phenomena (great view but unable to intubate) is linked to VL blades that are, unlike the traditional Macintosh blade, hyperangulated. Because of the unique profile that follows the anatomical shape of the human airway, alignment of the oropharyngeal-laryngeal axes becomes unnecessary to visualize the glottis.

 

The new challenge is now to also bring the tip of the ETT to the level of the glottis, pass the glottis and advance the tube inside the trachea. Several techniques have been proposed to meet this challenge; many authors proposed using a stylet to give the tube the shape of a “hockey stick” to follow the curvature of the video blade. However, ETT placement is often associated with a prolonged time for intubation. Additionally, stylet use for video laryngoscopy has been linked to an increased risk of soft tissue injury of the upper airway.

 

The success of a Videolaryngoscope assisted intubation depends on multiple factors, such as blade design (acute angled or Macintosh like; channeled or non-channeled); quality of the image on the monitor, as well as the experience of the intubator .

 

Hence we hypothesize from above findings that for the same reasons mentioned in above studies, perhaps we may have an alternative device in the form of HugeMed  VL3 ,which could be comparable to the king vision non channeled device in terms of easy and quick intubation time.

 

Therefore, the present study is aimed at comparing the VL3 videolaryngoscope and the king vision video larygnoscope,  in terms of airway management times, performance indices, hemodynamics and complications, if any, in adult patients scheduled for elective surgery.

 

 
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