| CTRI Number |
CTRI/2025/09/095086 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| 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
|
comparative study between Use of split nasopharyngeal airway for endoscopic nasal intubation and conventional endoscopic nasal intubation in temporomandibular joint ankylosis in pediatric age group. |
|
Scientific Title of Study
|
Use of split nasopharyngeal airway for endoscopic nasal intubation in temporomandibular joint ankylosis in pediatric age group. |
| 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 Rachamalla Ashritha Reddy |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8247551980 |
| Fax |
|
| Email |
rashritha5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Meena |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9643975465 |
| Fax |
|
| Email |
drrajaiims86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumar Meena |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9643975465 |
| Fax |
|
| Email |
drrajaiims86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Rachamalla Ashritha Reddy |
| Address |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
| 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 |
| Prof Rajesh Kumar Meena |
Trauma Centre,institute of medical sciences ,Banaras Hindu University |
Department of Anesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH |
9643975465
drrajaiims86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BHU Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic nasal intubation and endoscopic nasal intubation using split nasopharyngeal airway |
Endoscopic nasal intubation in one group of participants and endoscopic nasal intubation using split nasopharyngeal airway in other group of participants in temporomandibular joint ankylosis in pediatric age group |
| Comparator Agent |
using split nasopharyngeal airway |
Endoscopic nasal intubation using split nasopharyngeal airway in temporomandibular joint ankylosis in pediatric age group |
| Comparator Agent |
without split nasopharyngeal airway |
Endoscopic nasal intubation in temporomandibular joint ankylosis in pediatric age group |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1 Admitted to hospital for temporomandibular joint ankylosis surgery
2 With no upper respiratory tract infections |
|
| ExclusionCriteria |
| Details |
1 Refusal from patient or attenders
2 Patients with contraindications for nasal intubation like head trauma or base of skull fracture or deviated nasal septum or adenoid hyperplasia or nasal mass
3 History of asthma or COPD
4 Patients on anti convulsants or antidepressants
5 Patients having ongoing upper respiratory tract infections |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken in minutes for intubation using Conventional fiberoptic intubation and time taken for intubation using split nasopharyngeal airway |
Time taken for intubation in minutes is calculated from insertion of scope into nares to the inflation of Endotracheal tube cuff |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observe episodes of desaturation & complications like cough or bleeding or laryngospasm during procedure time measured in minutes |
Pulse oximeter is used for observing desaturation
HELBO HENSEN scale is used for cough |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="0"
Months="7"
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 study is Single blinded prospective randomized controlled trial comparing endoscopic nasal intubation using split nasopharyngeal airway and nasal intubation using conventional fiberoptic in Temporomandibular joint ankylosis in pediatric age group and will be carried out in Trauma Centre, Department of Anesthesiology , Institute of Medical Sciences , Banaras Hindu University , Varanasi, The primary outcome of study is comparing time taken for endoscopic nasal intubation using split nasopharyngeal airway to time taken for intubation using Conventional fiberoptic and secondary outcomes of the study is to observe episodes of desaturation and complications like cough , bleeding and laryngospasm during the procedure |