| CTRI Number |
CTRI/2025/04/085215 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing The Ease Of Intubation In Pediatric Patients By Using 2 Blades:
McCOY Laryngoscope And C MAC Videolaryngoscope Blade Size 2 undergoing elective surgery under general anesthesia |
|
Scientific Title of Study
|
Comparison Between McCOY Laryngoscope Blade 2 And C MAC Videolaryngoscope For Laryngoscopic View And Ease Of Intubation In Pediatric Patients Undergoing Elective Surgery Under General Anaesthesia:A Randomised Controlled 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 Sharanya S Narayana |
| Designation |
Junior Resident |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7022477925 |
| Fax |
|
| Email |
Sharanya.satyanarayana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Mane |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
Drrajeshmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Mane |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844131062 |
| Fax |
|
| Email |
Drrajeshmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, Karnataka. India. Pincode-590010 |
|
|
Primary Sponsor
|
| Name |
Dr Sharanya S Narayana |
| Address |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka |
| 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 Sharanya S Narayana |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Anaesthesiology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Jawaharlal Nehru Medical College campus, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA |
7022477925
Sharanya.satyanarayana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intubation with CMac videolaryngoscope blade 2 |
General anaesthesia is mostly used for surgical procedures in pediatric patients.Endotracheal intubation is the main element of pediatric airway management.After obtaining approval from ethical committee,pre anesthetic evaluation is done.Informed consent is taken from the patients parent/guardian.Opaque envelope method is used for randomisation of patients.Patients arenshifted into OT.After giving premedications and preoxygenation with 100% oxgyen intubation is attempted with C-Mac videolaryngoscope blade 2 and the glottic view is noted.Tracheal intubation is done with appropriate size Endotracheal tube.The tube is fixed after confirming air entry by auscultation.Finally Intubation Difficulty Score is noted. |
| Comparator Agent |
Intubation with McCoy Blade size 2 |
Pediatric patients posted for elective surgery are evaluated.
After obtaining consent from the parent/guardian,patient is shifted into the OT.Premedications and preoxygenation with 100% oxygen is done.Intubation is attempted with McCoy blade size 2.The glottic view and Intubation difficulty score is assessed similar to the other group |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II pediatric patients undergoing elective surgery under general anesthesia with consent from the parent/guardian |
|
| ExclusionCriteria |
| Details |
Pediatric patients having asthma,impaired pulmonary function and patients whose parent/guardian decline to give consent |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the glottis visualisation using Cormack-Lehane grading |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of intubation with Intubation Difficulty Score and Hemodynamic parameters |
Heart rate and saturation are monitored for the first 30 minutes post intubation at an interval of 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
10/05/2025 |
| 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="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
|
General anaesthesia is a commonly used procedure in pediatric surgeries. Airway related complications have a high perioperative incidence in pediatric patients. Thus, endotracheal intubation represents the main element of pediatric airway management for safety. In children, endotracheal intubation is difficult compared to adults due to anatomic differences i.e, epiglottis is large, floppy and omega shaped, makes an angle of 450 with the base of tongue. At birth, larynx is situated opposite to the lower border of C4 vertebra, it descends to C4-C5 interspace by the age of 3yrs & finally descends to lie opposite to the body of C5. Due to these differences anaesthesiologists encounter more difficult airway in pediatric patients.Hence,conventional direct laryngoscopy by McIntosh & Miller blade delayed tracheal intubation in difficult airway leading to increased mortality in pediatric population due to hypoxia. McCoy laryngoscope blade has a hinged tip with a lever control that aids in lifting the large epiglottis for an improved glottis view. While,CMac videolaryngoscope gives a better laryngoscopic view during intubation. Data for pediatric group is still insufficient. Most studies are done on comparison of CMAC video laryngoscope with McCoy blade in difficult airway in adults, whereas studies involving McCoy blade size 2 in pediatric difficult airways is insufficient and poses a great scope. Thus,in this randomised study,we want to see the ease of intubation and compare the glottic view during intubation between the McCoy blade and CMac videolaryngoscope of the blade size 2 in pediatric patients.
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