| CTRI Number |
CTRI/2023/08/056551 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
30/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact Of Pillow Height On Glottic View In ICU Patients |
|
Scientific Title of Study
|
Impact of pillow height On glottis view in ICU patients- A prospective randomised 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 |
Dr Srikar Goud G B |
| Designation |
Anaesthesia PG Resident |
| Affiliation |
MS RAMAIAH MEDICAL COLLEGE |
| Address |
Post Graduate Department Of Anaesthesiology MS RAMAIAH MEDICAL COLLEGE New BEL Road MS Ramaiah Nagar MSRIT POST BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9482829299 |
| Fax |
|
| Email |
srk.srikar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas K N |
| Designation |
Associate Professor |
| Affiliation |
MS RAMAIAH MEDICAL COLLEGE |
| Address |
Department Of Anaesthesiology MS RAMAIAH MEDICAL COLLEGE New BEL ROAD MS Ramaiah Nagar MSRIT POST BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9844186745 |
| Fax |
|
| Email |
vikas.vikas7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Vikas K N |
| Designation |
Associate Professor |
| Affiliation |
MS RAMAIAH MEDICAL COLLEGE |
| Address |
Department Of Anaesthesiology MS RAMAIAH MEDICAL COLLEGE New BEL Road MS Ramaiah Nagar MSRIT POST BANGALORE
Bangalore
KARNATAKA
560054
India |
| Phone |
9844186745 |
| Fax |
|
| Email |
vikas.vikas7@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical College New BEL road M S Ramaiah Nagar
MSRIT Post Bangalore KARNATAKA 560054 India
|
|
|
Primary Sponsor
|
| Name |
M S Ramaiah Medical College |
| Address |
M S Ramaiah Medical College New BEL road M S Ramaiah Nagar
MSRIT Post Bangalore KARNATAKA 560054 India
|
| 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 Srikar Goud G B |
MS Ramaiah Medical College Hospital |
Department of
Anaesthesiology
Second Floor MS
Ramaiah Medical
College Hospital New
BEL Road Bangalore
Bangalore
KARNATAKA |
9482829299
srk.srikar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
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 |
Pillow |
Using an appropriately sized Macintosh blade, direct laryngoscopy will be performed, and
the glottic view will be assessed without a pillow, or with non-compressible pillows of 5 cm
or 10 cm height in random order. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients getting admitted in ICU and requiring
intubation.Patients who are hemodynamically stable.
Patients not having respiratory distress.
|
|
| ExclusionCriteria |
| Details |
Body mass index (BMI) <18.5 or >30.Anticipated difficult airway.Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Glottic View will be assessed based on CL grading
Grade 1 – Full view of glottis
Grade 2A – Partial view of glottis
Grade 2B – Only arytenoids seen
Grade 3 – Only epiglottis seen
Grade 4 – Neither epiglottis nor glottis seen |
While Intubating at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of
attempts for successfull intubation |
three different pillow
heights (without a pillow, 5 cm, & 10 cm) |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
01/09/2023 |
| 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="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
|
Direct laryngoscopy is used to facilitate tracheal intubation under vision. The key
step for successful laryngoscopy is optimal positioning.
1 Proper head positioning
facilitates good glottic view and minimize tracheal injury, duration and repeated attempts
of laryngoscopy/intubation and reducing complications.
2
The most commonly used head position is ‘sniffing position’. It consists of neck flexion
of approximately 35°and atlanto occipital joint extension of approximately 15°. This
aligns the oral, pharyngeal, and laryngeal axis in straight line, permitting the line of
vision to fall directly on the laryngeal inlet.
The neck flexion component of the sniffing position is generally achieved by simple
flexion of the head without a pillow or with a pillow of height up to 5-10 cm.
3,4
Limited studies are available for assessing the optimal pillow height for obtaining the
best glottic view during laryngoscopy and intubation in the Indian population. Hence, the
present study has been taken up to evaluate laryngoscopic view and intubation conditions
with three different pillow heights |