| CTRI Number |
CTRI/2026/01/101502 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nasotracheal intubation using CT scans to improve safety in patients with midface injuries: a clinical trial. |
|
Scientific Title of Study
|
Preoperative evaluation of nasal cavity using computed tomography to reduce complications during nasotracheal intubation in midface trauma patients: a clinical trial |
| 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 Kairav A Vadher |
| Designation |
Postgraduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental science |
| Address |
Department of Oral and Maxillofacial Surgery KAHERs KLE VK Institute of Dental sciences Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7600030043 |
| Fax |
|
| Email |
kairav.vadher@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kairav A Vadher |
| Designation |
Postgraduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental science |
| Address |
Department of Oral and Maxillofacial Surgery KAHERs KLE VK Institute of Dental sciences Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7600030043 |
| Fax |
|
| Email |
kairav.vadher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejraj P Kale |
| Designation |
Professor |
| Affiliation |
KAHERs KLE VK Institute of Dental science |
| Address |
Department of Oral and Maxillofacial Surgery KAHERs KLE VK Institute of Dental sciences Nehrunagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448472891 |
| Fax |
|
| Email |
tejrajkale@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KAHERs KLE VK Institute of Dental sciences Nehrunagar Belagavi Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Kairav A Vadher |
| Address |
Department of Oral and Maxillofacial Surgery KAHERs KLE VK Institute of Dental sciences Nehrunagar Belagavi |
| 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 Kairav A Vadher |
Dr Kairav A Vadher |
Room no 5 Department of Oral and Maxillofacial Surgery KAHERs KLE VK Institute of Dental sciences Nehrunagar Belagavi Karnataka India 590010
Belgaum
KARNATAKA |
7600030043
kairav.vadher@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and ethics commitee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T884||Failed or difficult intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Preoperative Computed tomography assessment of Nasal Cavity |
Patient will recieve Computed tomography assessed Nasotracheal Intubation for airway management in general anesthesia for midface fractures surgeries. Duration till patient get extubated after completion of the surgery, frequency- one time preoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis: Patients presenting with maxillofacial midface trauma requiring surgical intervention.
2.Intubation requirement: Patients who require nasotracheal intubation for surgical management.
3.CT imaging availability: Patients for whom preoperative computed tomography imaging has been done.
4.Consent: Patients who provide informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to participate in the study.
2.The lack of preoperative CT scans.
3.When other forms of the intubation may be required as judge by the anaesthesiologist.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of post operative complications ie incidence of bleeding |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts for Intubation |
Baseline |
| Assessment of intubation difficulty & time taken for the procedure |
Baseline |
| Incidence of any other complications |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2026 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kairav.vadher@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Summary:
Need for the study
1. Maxillofacial trauma often complicates airway
management due to preexisting and post trauma anatomical distortions, making
conventional intubation methods difficult and increasing the risk of
complications.
2. Nasal intubation is preferred in maxillofacial surgeries as it allows better
access to the surgical field. Careful assessment and preparation of the patient
before the procedure are important. There is inability to pass ET tube Nasally.
Various complications are nasal bleeding, avulsion of nasal polyps, fracture of
the turbinate and risk of sinusitis.
3. Utilizing computed tomography (CT) imaging can provide detailed anatomical
information for safe intubation.
Objectives
1. To Measure the incidence of complication
i.e. Bleeding during intubation and the number of attempts and time
required to successfully perform nasal intubation.
2.To assess the intubation difficulty from
the Preoperative evaluation of Nasal anatomy using CT scans.
Intervention to be
conducted on patients- Preoperative
CT scan (Which is done previously for assessment of diagnosis for maxillofacial
midface trauma patients).
|