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CTRI Number  CTRI/2024/10/074550 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PILOT STUDY 
Study Design  Other 
Public Title of Study   COMPARISON OF DIFFERENT ANGLES OF RAMPED POSITION ON VIDEOLARYNGOSCOPE IN INDIAN ADULT PATIENTS.  
Scientific Title of Study   COMPARATIVE EVALUATION OF EFFECT OF DIFFERENT ANGLES OF RAMPED POSITION ON VIDEOLARYNGOSCOPIC GLOTTIC VIEWS FOR TRACHEAL INTUBATION IN INDIAN NON-OBESE ADULT PATIENTS- A PILOT STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravneet kaur boparai 
Designation  PG resident 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anesthesia School of Medical Sciences and Research and Sharda Hospital,Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  7707962621  
Fax    
Email  2022008315.ravneet@pg.sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Ashok Kumar Sethi 
Designation  Professor 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anesthesia School of Medical Sciences and Research and Sharda Hospital,Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  8368116645  
Fax    
Email  newdraksethi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashok Kumar Sethi 
Designation  Professor 
Affiliation  School of Medical Sciences and Research 
Address  Department of Anesthesia School of Medical Sciences and Research and Sharda Hospital,Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201306 India

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  8368116645  
Fax    
Email  newdraksethi@gmail.com  
 
Source of Monetary or Material Support  
School of Medical Sciences and Research and Sharda Hospital,Greater Noida, India Pin 201310 
 
Primary Sponsor  
Name  School of Medical Sciences and Research and Sharda Hospital Greater Noida 
Address  School of Medical Sciences and Research and Sharda Hospital,Greater Noida, India Pin 201310 
Type of Sponsor  Private 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 Ashok Kumar Sethi  Sharda hospital  Department of Anesthesia, 2nd floor hospital buidling B blcok
Gautam Buddha Nagar
UTTAR PRADESH 
8368116645

newdraksethi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,School of Medical Sciences and Research ,Sharda University,Greater Noida  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  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  A)Age between 18-65 years.
B)ASA physical status I-II.
C)All classes of Modified Mallampati score
 
 
ExclusionCriteria 
Details  Anticipated difficult bag-mask ventilation
Failure to mask ventilate after injection of induction agent
Restricted flexion and extension movements of head & neck Patients planned for awake intubation, nasal intubation or rapid sequence induction/intubation due to any cause
History of upper airway disease or respiratory infection in the last 15 days
Patients posted for surgeries involving oral cavity, larynx, pharynx and neck

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
POGO score  Intraoperative 
 
Secondary Outcome  
Outcome  TimePoints 
Cormack & Lehane grade  Intraoperative 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   04/10/2024 
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="1"
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  

Airway management during anaesthesia is an important determinant of morbidity and mortality despite progress in identifying factors that can predict difficult mask ventilation and endotracheal intubation (ETI). of the prerequisites described for successful laryngoscopy and ETI is optimal patient positioning. ‘Sniffing’ position (SP) which involves neck flexion at chest and head extension at atlanto-occipital (AO) joint is conventionally considered ideal for direct laryngoscopy (DL) as it is believed to align oro-pharyngeal and laryngeal axes of the patient for allowing the line of vision of the operator to fall directly on the laryngeal inlet.2 In view of the importance of positioning for laryngoscopy and ETI, many studies have been conducted to establish optimal patient positioning but their results and recommendations are dissimilar.3 Some of these include changing the pillow height,4 utilizing ramped position,5 using maximum head extension or no head extension,6 head-elevated-laryngoscopy position5 and back-up position5 etc.

Ramped position, also referred to as back-up or head-elevated position involves flexion of the patient at hips and was introduced to offer better laryngeal exposure during DL in morbidly obese patients than the patients in the sniffing position7and has been said to facilitate better alignment of the pharyngeal, laryngeal and oral axis of the airway during difficult laryngoscopy, especially in the large patients.8 Some studies found this position usefulin non-obese conditions also.Various techniques have been used to achieve the elevation for ramping, viz., stack of pillows, towels, blankets, specially designed commercially available foam pillows and adjustment of head end of the operating table.10 Hospital pillows, towels or blankets are most frequently used for making ramps during airway management but have many disadvantages like more time-consumption11,difficulties in arranging appropriate linen in sufficient quantities for making ramp, requirement of lifting the patient during positioning12 and alignment of External Auditory Meatus - Sternal Notch (EAM-SN) line vs. horizontal, difficulty of removing the blankets after the procedure, inability to quantify the ramp angle, difficulties in changing the angle of ramp if required, difficulties in achieving the targeted height of the head of patient for laryngoscopy and intubation and almost no possibility to replace the blankets in order to realign the patient for the best position for airway management after tracheal extubation.12 Commercially available foam pillow ramps have not become popular because of their cost factor11 and use of operating table ramp has also proven difficult and with no specific guidelines.Though a few studies have recommended 25° ramp for favourable conditions for DL in obese patients,14 degree of elevation required for appropriate ramping is still a big question and achieving different angles of ramp with the existing ramping methods is very difficult. Moreover, any simple ramping device which can offer variable angles of ramp according to requirements is also not available.A recommendation of an endpoint of horizontal alignment of the patient’s EAM with SN line during ramping has also been suggested7 as a good end-point for DL in both obese as well as non-obese patients, as it is said to provide a closer alignment of pharyngeal, laryngeal and oral axes.15Video-laryngoscopy (VL) has been found to provide a better laryngeal view, reduced rate of oesophageal intubation, higher first-attempt intubations as compared to DL in general population suggesting that VL is an excellent alternative to DL in many normal as well as difficult airway scenarios.16However, the present guidelines for ramping for DL may not apply to VL because of the difference in geometric design of the two types of laryngoscopes in terms of angle of the blade and difference in the mechanics of visualization of glottis and the required line-of-vision in view of location of a camera only a few millimetres before the vocal cords in video-laryngoscopes and provision of the image of glottis on an external monitor.17 Similarly, due to different mechanics of obtaining the glottic views in the two techniques, results of correlations of different angles of EAM-SN line vs. horizontal in the videoscopic image obtained with video-laryngoscope may be different than that of DL. Lacunae in the existing knowledgeExtensive search of literature reveal that there are no studies which recommend any specific ramping positions for achieving most favourable glottic views and best intubating conditions during VL. Moreover, no studies have recommended any specific angle of ramp for use of ramped position to achieve best results in terms of laryngoscopic views and intubation with VL. Likewise, there are no studies to provide any information on the relationship of angle of EAM-SN line vs. horizontal axis while utilizing different angles in the ramp during video-laryngoscopy and no recommendations are also available on this subject. In view of the above and importance of ramp position for laryngoscopy and ETI, difficulties associated with the use of existing methods for making the ramp  and a real need to search the best angle of ramp suitable to provide best glottic views and intubating conditions during VL, a simple, self-fabricated, portable ramping device made up of acrylic polystyrene which is strong enough to hold the weight of the patient and which can provide an adjustable ramp angle of 15°, 20° and 25° without physically lifting the patient during use, was designed for the present study. This device henceforth would be called as Sethi’s Ramp Positioner (SRP). Therefore, the present randomized pilot study was designed to evaluate and compare the glottic views according to Percentage of Glottic Opening (POGO) score and modified Cormack and Lehane (MCL) grade, ease of insertion of the blade of video-laryngoscope, need of optimization manoeuvres for facilitating ease of intubation, intubation difficulty score (IDS), time to successful intubation, number of Intubation attempts, incidence of failure to intubate using VL and correlation of angles of ‘EAM-SN line vs. horizontal’ using head-flat position and 15°, 20° and 25° angles of ramped position using SRP in Indian non-obese adult patients and to recommend, if possible, the most optimal angles of ramp during VL for best outcomes.

 
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