| 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
|
|
|
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
|
|
|
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. |