| CTRI Number |
CTRI/2025/08/092296 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two head positions for better vocal cord visualization during intubation using video laryngoscopy in adults with predicted difficult airway |
|
Scientific Title of Study
|
Comparison of POGO score with video laryngoscopy in supine position and HELP position in adult patients with anticipated difficult airway- A randomized controlled tri-al.
|
| 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 Anish Banstola |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8960846255 |
| Fax |
|
| Email |
anishbanstola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gnanasekaran S |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487188275 |
| Fax |
|
| Email |
gnansdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anish Banstola |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and critical care,2nd floor institute
block, JIPMER campus, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8960846255 |
| Fax |
|
| Email |
anishbanstola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER campus road, Gorimedu, Dhanvantri nagar, Pondicherry, India
605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER Campus Road, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anish Banstola |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of
Anesthesiology and
critical care office,
Second floor institute
block,
Gorimedu, Pondicherry 605006
India
Pondicherry
PONDICHERRY |
8960846255
anishbanstola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic committee- interventional studies JIPMER, Puducherry |
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 |
Head-Elevated Laryngoscopy Position (HELP) |
In this group, video laryngoscopy is performed with the patient in the HELP position. HELP position will be achieved by raising the back section of OT table and the end point will be the alignment of EAM and sternal notch in horizontal plane and folded towels or pillow will be kept under the head to achieve the end point of alignment of EAM and sternal notch in horizontal line parallel to floor. POGO score and intubation parameters will be recorded.
Duration of study will be 3 to 5 minutes after induction. |
| Comparator Agent |
Sniffing position |
Sniffing position will be achieved by placing a pillow of 7 cm beneath the head. POGO score and intubation parameters will be recorded.
Duration of study will be 3 to 5 minutes after induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients more than 18 years of age with ASA grade I and II undergoing elective surgery under general anesthesia requiring endotracheal intubation and having one or more of the following
1.Neck circumference: greater or equal 42 cm
2.MMP grade III and IV
3.Positive upper lip bite test (grade 3)
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1.Patient undergoing emergency surgery
2.Any Facial or cervical spine trauma
3.Pregnant women
4.Morbid obesity (BMI greater than 40kg per m2)
5.Any oropharyngeal tumors
6.Patient requiring nasotracheal intubation
7.Restricted neck extension
8.Mouth opening: less than 5 cm
9.Known craniofacial abnormalities and congenital syndromes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the laryngeal view using Per-centage of glottic opening (POGO score) between two study groups |
3 minutes after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the first attempt success rate of intubation between two groups
2.Comparison of time for successful intubation.
3.Comparison of ease of intubation between two groups using 5 points likert scale.
4.Comparison of intubation difficulty score using modified intubation difficulty scale between two groups.
5.To compare the need of external laryngeal manipulation.
5.To assess & compare intubation complication rate including esophageal intubation, airway trauma, desaturation, bronchospasm between the two groups.
|
3 to 5 minutes after induction |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
15/09/2025 |
| 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
|
This randomized controlled trial evaluates the effectiveness of the Head Elevated Laryngoscopy Position (HELP) versus the supine sniffing position in improving glottic visualization during intubation in adult patients with anticipated difficult airways. Using the C-MAC video laryngoscope, 114 patients undergoing elective surgeries were randomized into two groups: one intubated in the supine position, and the other in the HELP position, which aligns the external auditory meatus with the sternal notch. The primary outcome measured was the Percentage of Glottic Opening (POGO) score. Secondary outcomes included first-attempt success rate, time to intubation, ease and difficulty of intubation, need for external laryngeal manipulation, and complications. The study aims to determine whether the HELP position offers superior laryngeal visualization and intubating conditions in comparison to the supine position, potentially guiding better airway management strategies in difficult airway cases |