| CTRI Number |
CTRI/2024/12/078241 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Acromio-axillo-suprasternal notch Index as a predictor of difficult Laryngoscopy in Paediatric patients- An observational study |
|
Scientific Title of Study
|
Evaluation of the Acromio-Axillo-Suprasternal notch Index as a predictor of difficult Laryngoscopy in Paediatric patients- An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh G M |
| Designation |
PG Resident |
| Affiliation |
|
| Address |
Dept of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, India
Bangalore
KARNATAKA
560077
India |
| Phone |
09740584234 |
| Fax |
|
| Email |
rishabhmankale@rocketmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purvashree deshmukh |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Dept of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, India
Belgaum
KARNATAKA
590010
India |
| Phone |
7026083555 |
| Fax |
|
| Email |
purvashreedeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purvashree deshmukh |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Dept of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, India
Belgaum
KARNATAKA
590010
India |
| Phone |
7026083555 |
| Fax |
|
| Email |
purvashreedeshmukh@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore Hospital and Medical research centre, Nehru Nagar, Belagavi, Karnataka, India Pin- 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Rishabh GM |
| Address |
KLE Campus, Nehru Nagar, Belagavi, Karnataka, India 590010 |
| 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 Purvashree Deshmukh |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Department of Anaesthesiology |
KLE Campus, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA |
7026083555
purvashreedeshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Paediatric patients aged between 2 to 10 years undergoing elective surgery under General anaestheia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Children undergoing elective surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
ASA III and above
Children with obvious airway anomalies
Children with tumours in Upper airway( oral cavity, pharyngeal and glottic cancers)
Children with restricted mouth openings due to injuries or other causes |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the utility of the Acromio-Axillo-Suprasternal Notch Index as a predictable tool for difficult laryngoscopy in paediatric patients ages 2 to 10 years |
at time of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish a co-relation between the AASI and the Cormack- Lehane grading which classifies the difficulty of laryngoscopic visualisation during tracheal intubation |
during larynngoscopy |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
17/01/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Endotracheal intubation is a critical component of general anaesthesia, Paediatric patients present additional challenges due to their unique anatomical conditions, congenital anomalies, and limited availability of appropriately sized equipment. The consequences of difficult airway and difficult intubation can be more severe than in adults due to their high oxygen consumption and low oxygen reserves, which can lead to rapid desaturation and bradycardia. Although many criteria are present in the literature to predict difficult airwat, a predictor with high sensitivity and specificity remain elusive. Hence, this study is ebing undertaken to determine efficacy of AASI as a predictor of difficult laryngoscopy and intubation. |