FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/09/057550 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 11/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PILOT STUDY 
Study Design  Other 
Public Title of Study   Glottic views using Videolaryngoscope by using head elevation with pillows of variable heights. 
Scientific Title of Study   Comaparative evaluation of effect of using different pillow heights on Glottic views and Intubating conditions using Videolaryngoscope in non-obese Indian 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  Durray Shehwar 
Designation  PG Resident 
Affiliation  School of Medical Sciences and Research and Sharda Hospital, Greater Noida 
Address  Department of Anaesthesia, School of Medical Sciences and Research and Sharda Hospital, Greater Noida. Gautam Buddha Nagar.

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9873216372  
Fax    
Email  2022007735.durray@pg.sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr.ASHOK KUMAR SETHI 
Designation  Professor 
Affiliation  School of Medical Sciences and Research and Sharda Hospital 
Address  Department of Anaesthesia, School of Medical Sciences and Research and Sharda Hospital, Greater Noida Gautam Buddha Nagar
Department of Anaesthesia, School of Medical Sciences and Research and Sharda Hospital,Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  8368116645  
Fax    
Email  newdraksethi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.ASHOK KUMAR SETHI 
Designation  Professor 
Affiliation  School of Medical Sciences and Research and Sharda Hospital 
Address  Department of Anaesthesia, School of Medical Sciences and Research and Sharda Hospital, Greater Noida, Gautam Buddha Nagar
Department of Anaethesia,School of Medical Sciences and Research, Greater Noida.
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 
 
Primary Sponsor  
Name  School of Medical Sciences and Research and Sharda Hospital, Greater Noida 
Address  Knowledge Park III, Greater Noida 
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 
DrDurray Shehwar  School of Medical Sciences and Research and Sharda Hospital,Sharda University  Department of Anaesthesia,Floor no. 2 Block-B SMS&R and Sharda Hospital, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 
9873216372

2022007735.durray@pg.sharda.ac.in 
 
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  1.Age 18-65 years.
2.ASA physical status I-II.
3.All classes of Modified Mallampati class
 
 
ExclusionCriteria 
Details  a)Anticipated difficult bag-mask ventilation
b)Failure to mask ventilate after injection of induction agent
c)Inter-incisor gap <3.0 cm
d)Thyromental distance <6.5 cm
e)Obesity : BMI ≥ 30 kg/m2
f)Restricted flexion and extension movements of head & neck
g)Indication for awake or nasal intubation or rapid sequence induction/intubation
h)Patients posted for surgeries involving oral cavity, larynx, pharynx and neck
i)History of upper airway disease or respiratory infection in the last 15 days
j)Risk of pulmonary aspiration of gastric contents e.g., pregnant females, patients with full stomach, upper GIT problems like gastro-oesophageal reflux disease
k)Pathological causes of difficult laryngoscopy such as malformation of the face, cervical spine disorders, tumours of the airway, sleep apnoea syndrome, and prominent upper incisors
 
 
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 
1. POGO score
The percentage of glottic opening (POGO) score corresponds to the percentage of the glottis visualized during laryngoscopy. A 100% value denotes visualization of the entire glottis from the anterior commissure of the vocal cords to the inter-arytenoid notch. If none of the glottic opening is visualised , then the value is stated as 0%. Percentage of view of the glottic opening between 0-100% will be noted according to the view obtained with VL in each group.
 
The percentage of glottic opening (POGO) score shall be recorded in supine head flat position followed by head elevation of 4cm,6m and 8cm after induction of anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
2.Modified Cormack & Lehane score
3.Ease of insertion of videolaryngoscope
4.Need of optimization manoeuvres for facilitating ease of intubation
5.Intubation Difficulty Score
6.Number of Intubation attempts
7.Time to successful intubation
8.Failure to intubate
9.Angle of EAM-SN line in comparison to horizontal axis
10.Any complications during the test procedure
 
Percentage of glottic opening (POGO) score shall be recorded in head flat supine position followed by head elevation of 4cm,6cm & 8cm after induction of anaesthesia. 
 
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)   21/09/2023 
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="6"
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  

Laryngoscopy and endotracheal intubation are amongst the most important procedures for the anaesthesiologists performing airway management during routine as well as emergency general anaesthesia in the operating rooms.

A Macintosh type direct laryngoscope is most routinely used for direct laryngoscopy (DL) under direct vision to perform endotracheal intubation in ‘sniffing’ position which is classically described as optimal position of head and neck for this purpose as it allows closer alignment of the pharyngeal and laryngeal axes with oral axis to provide a better line of vision for DL.1,2 ‘Sniffing’ position is achieved by flexing the neck over the chest and extending the head at atlanto-occipital (AO) joint with the help of pillows, head rings or towels under the head. However, there are conflicting reports on this issue which proclaim that these axes can never be perfectly aligned and provide no significant advantage during DL and tracheal intubation.3

One of the latest additions to the series of laryngoscopes is video laryngoscope which is used almost in the same manner as Macintosh type direct laryngoscope. Videolaryngoscopy (VL) provides the view of the glottis by utilizing a digital video camera located at the point of angulation of the blade to generate a view of the glottis in a separate small colour LCD monitor. Such video laryngoscopes have been found to be useful for tracheal intubations in various clinical situations related to normal as well as difficult airways.4

In a situation during induction of anaesthesia when a patient is in ‘‘sniffing’ position’ and the initial attempt at DL proves difficult or fails, VL is used as a rescue method if the videolaryngoscope is available. While proceeding for VL, most anaesthesiologists are habitual of keeping the patient in the same position of head and neck as DL without any alteration. A suboptimal position for DL as well as VL can result in a wasted attempt for intubation and further repeated attempts can result in poor outcomes including death.1

Poor laryngoscopic visualizations and difficult/failed intubations with DL have prompted the anaesthesiologists to try many modified positions of head & neck for achieving better laryngoscopic views and successful intubations. Some of these include changing the pillow height5, utilizing ramped position6, using maximum head extension or no head extension6, head-elevated-laryngoscopy position6 and back-up position6 etc. Various pillow heights from 3.0 cm to 13.5 cm have been tried in ‘‘sniffing’ position’ by various authors but no clear-cut established universal consensus on this subject has been reached and very conflicting recommendations about pillow heights for DL have surfaced viz., 4.0, 4.5, 5.0, 7.0, 9.0 and even 10.0 cm. 7,8,9Credibly in the present day context when video-laryngoscopes are being more frequently and successfully used for difficult laryngoscopy and tracheal intubation as a rescue tool, VL is now being suggested by several authors to be accepted as first choice method for all intubations.10 Despite recognising the utility of VL, still there are no reports recommending any specific head and neck position for best glottic views for tracheal intubation with video-laryngoscopes.

Most recently, a secondary indicator i.e., horizontal alignment of external auditory meatus (EAM) and supra-sternal notch (SN) which is not directly related to airway configuration, has also been suggested to allow closer alignment of pharyngeal, laryngeal axes and oral axis to provide a better line of vision for DL and has been recommended as a satisfactory endpoint for getting optimal head and neck position for laryngoscopy in obese as well as non-obese patients, irrespective of degree of head elevation.11 However, there is no study which mentions the change in angle of EAM-SN line in comparison to the horizontal axis in different head and neck positions for VL.

In view of the fact that optimal positioning of head & neck has been well accepted as an essential requirement for laryngoscopy12 and intuitively, there are discordant results about the utility of ‘sniffing’ position and a clear-cut pillow height for better laryngeal exposure with DL7 and moreover, role of  ‘sniffing’ position is ambiguous while performing VL, in view of no need to align three anatomical axes to obtain a direct view of glottis during VL and literature is still devoid of any studies which recommend any specific positioning of head and neck for video laryngoscopy, the present study was planned to assess using video-laryngoscope, the effects of different head and neck positions, namely, flat without head elevation and with pillow heights of 4, 6 and 8 cm for head elevation on the Percentage of Glottic Opening (POGO) score,13 modified Cormack and Lehane (MCL) grade,14 ease of insertion of videolaryngoscope, need of optimization manoeuvres for facilitating ease of intubation, intubation difficulty score (IDS), time to successful intubation, number of Intubation attempts, failure to intubate and angle of EAM-SN line in comparison to the horizontal axis and to recommend the most optimal pillow height for best outcomes with VL.

Lacunae in the existing knowledge

Extensive search of literature revealed that there is no study which suggests or recommends any specific head & neck position for best glottic views and easy intubation while using videolaryngoscope and which also compares the effect of using different pillow heights on glottic view, easiness in insertion of blade of videolaryngoscope, ease of intubation, intubation difficulty score, time to successful intubation, number of Intubation attempts, failure to intubate and change in the angle of ‘EAM-SN line with horizontal’ with different pillow heights in adult patients. Though literature is full of various head and neck positions used for DL,15 the ideal head & neck position for VL has not been recommended till date, hence the present study.

 
Close