| CTRI Number |
CTRI/2025/12/098476 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two aids(dental putty vs gauze roll) for easier and safer intubation in children with cleft lip and palate. |
|
Scientific Title of Study
|
A Prospective Randomised Clinical Trial For Comparison of Dental Putty-Aided Endotracheal Intubation Versus Gauze Roll-Aided Endotracheal Intubation in Children with Left-Sided Complete Cleft Lip, Alveolus, and Palate. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavan Dhulkhed |
| Designation |
Professor |
| Affiliation |
SDM College of Medical Sciences and Hospital, Dharwad. |
| Address |
Department of Anaesthesia, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka.
Dharwad
KARNATAKA
580009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavan Dhulkhed |
| Designation |
Professor |
| Affiliation |
SDM College of Medical Sciences and Hospital, Dharwad. |
| Address |
Department of Anaesthesia, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka.
KARNATAKA
580009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavan Dhulkhed |
| Designation |
Professor |
| Affiliation |
SDM College of Medical Sciences and Hospital, Dharwad. |
| Address |
Department of Anaesthesia, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka.
KARNATAKA
580009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
|
Source of Monetary or Material Support
|
| Operation Theatres at SDM College of Medical Sciences and Hospital, Sattur, Dharwad. Karnataka. India
Pin Code: 580009 |
|
|
Primary Sponsor
|
| Name |
Pavan Dhulkhed |
| Address |
Department of Anaesthesia, SDM College of Medical Sciences and Hospital, Dharwad. Karnataka, India
Pin Code : 580009 |
| 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 Pavan Dhulkhed |
Operation Theatres, Department of Anaesthesia, SDM College of Medical Sciences and Hospital, Dharwad |
Manjushree Nagar, Sattur, Dharwad, Karnataka 580009
Dharwad
KARNATAKA |
8150885678
pavandhulkhed1984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q371||Cleft hard palate with unilateralcleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dental Putty aided endotracheal intubation |
Dental Putty aided endotracheal intubation |
| Comparator Agent |
Gauze Roll aided endotracheal intubation |
Gauze Roll aided endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged less than 5 years
2. ASA physical status 1 or 2
3. Diagnosed with uncorrected left sided complete
cleft lip, alveolus and palate |
|
| ExclusionCriteria |
| Details |
1. Children with anticipated difficult airway
unrelated to cleft
2. ASA physical status greater than 2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome is the Time required for successful endotracheal intubation. (Intubation time) |
Study parameters are recorded at the end of endotracheal intubation in both groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of attempts of endotracheal intubation
2. To compare Cormack-Lehane grades of glottic visualisation
3. To assess the need for external laryngeal manipulation
4. To grade the ease of intubation
5. To document complications like failed intubation, desaturation & mucosal injury. |
The secondary outcome parameters are recorded at the end of endotracheal intubation. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/01/2026 |
| 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="2"
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
|
This prospective randomized clinical trial compares dental putty aided versus gauze roll aided endotracheal intubation in children less than 5 years of age and ASA 1,2 with children having left sided complete cleft lip, alveolus and palate. Sixty patients will be allocated into two groups of 30 each. After standard anaesthetic induction, either dental putty or gauze roll will be placed in the cleft before laryngoscopy. Primary outcome is intubation time in seconds.
Secondary outcomes are number of attempts of intubation, Cormack-Lehane grade of glottic visualisation, need for external laryngeal manipulation, ease of intubation and complications like desaturation, trauma and failed intubation.
Dental putty is expected to provide better glottic visualization, shorter intubation time, lesser attempts of intubation, and fewer complications than the conventional gauze roll technique.
|