| CTRI Number |
CTRI/2025/02/080809 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using an airway scoring system to determine if placement of breathing tube will be difficult in children undergoing surgeries |
|
Scientific Title of Study
|
Utility of Colorado Pediatric Airway Score (COPUR) in predicting difficult airway
and intubation among children undergoing elective surgeries in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajith Aravind |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9656942807 |
| Fax |
|
| Email |
ajitharavind999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malavika Kulkarni |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.kulkarni@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malavika Kulkarni |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.kulkarni@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Anaesthesiology, Kasturba Medical College and Hospital, Manipal 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ajith Aravind |
Kasturba Medical College Manipal |
Department of Anaesthesiology, Baliga Block, 1st floor, Kasturba Medical College and Hospital, Manipal 576104
Udupi
KARNATAKA |
9656942807
ajitharavind999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 (Student Research) |
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 |
2.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children undergoing surgeries under general anesthesia |
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologists(ASA) Physical Status 4,5
Life threatening emergencies
Mentally challenged children |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess validity of COPUR scale in identifying children with difficult airway |
COPUR scale noted during routine pre anesthetic evaluation(day 0). The next day, difficulty of intubation is evaluated during intra operative period(day 1). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the various intubation aids that facilitate the ease of endotracheal intubation & compare it with COPUR score obtained |
COPUR score - during pre-anesthetic evaluation (Day 0)
Aids for intubation - during intubation in the operation theatre (Day 1) |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
20/02/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Identification of patients with a difficult airway is vital in planning anaesthetic management so that tracheal intubation can be achieved safely. Several preoperative screening tools are being used in clinical anaesthesia to identify adult patients who are difficult to intubate. A significant association is seen between non-invasive clinical predictors of airway assessment and the incidence of difficult intubation (DI), yet no single method is expected to predict DI accurately. Anaesthetic literature is deficient regarding airway assessment tools for paediatric patients. Hence the present study is being undertaken to assess the utility of COPUR scale in identifying children with difficulty in intubation. The Colorado Pediatric Airway (COPUR) scale was first described in an article by Geoffrey Lane. To
the best of our knowledge, there haven’t been studies conducted to assess its validity in predicting difficult intubation yet.
|