| CTRI Number |
CTRI/2025/11/096915 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two methods of tube placement for patients undergoing face and jaw surgery. |
|
Scientific Title of Study
|
A Randomized Comparative Study to Assess the Success Rate and Complication of Nasotracheal Intubation by Conventional Versus Finger-Guided Method Among Patients Undergoing Maxillofacial Surgery at SMS Medical College, Jaipur |
| 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 Rajni Mathur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology,
S.M.S medical college,
JLN marg,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829357194 |
| Fax |
|
| Email |
rajnimathur@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Mathur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology,
S.M.S medical college,
JLN marg,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829357194 |
| Fax |
|
| Email |
rajnimathur@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balakumar S |
| Designation |
Post Graduate Resident |
| Affiliation |
Sawai Man Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology,
S.M.S medical college,
JLN marg,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9092031426 |
| Fax |
|
| Email |
balakumar6653@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia SMS Medical College and Hospitals
JLN Marg, Jaipur,pincode 302004, Rajasthan,India. |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
Department of Anaesthesiology,
S.M.S medical college,
JLN marg,Jaipur,pincode 302004, Rajasthan,India. |
| Type of Sponsor |
Government 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 Rajni Mathur |
Plastic Surgery operation theatre,S.M.S Medical College,Jaipur |
Department of Anaesthesia, 2nd floor, Dhanvantri complex, SMS Medical College and Hospital, Jaipur,Rajasthan.
Jaipur
RAJASTHAN |
9829357194
rajnimathur@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, S.M.S Medical College and Attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (2) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (5) ICD-10 Condition: K135||Oral submucous fibrosis, (6) ICD-10 Condition: M269||Dentofacial anomaly, unspecified, (7) ICD-10 Condition: M279||Disease of jaws, unspecified, (8) ICD-10 Condition: M266||Temporomandibular joint disorders, (9) ICD-10 Condition: D165||Benign neoplasm of lower jaw bone, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional nasal intubation |
Endotracheal tube will be
moved blindly forward until
the endotracheal tube was
placed in its position and duration is around 2 to 3 minutes. |
| Intervention |
finger guided nasal intubation |
Endotracheal tube enters the
dominant nostril towards
nasopharynx,then the index finger of
the non dominant hand enters the
mouth and will be placed behind the
soft palate in the nasopharyngeal area and duration is around 2 to 3 minutes. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving written informed consent.
2. Patients undergoing oral maxillofacial surgery.
3. Patients of either sex aged between 15-70 years.
4. American Society of Anesthesiologists (ASA) physical status classes I
and II.
5. Scheduled for elective surgery. |
|
| ExclusionCriteria |
| Details |
1. Patient’s Presence of nasal mass.
2. Bleeding disorders.
3. Anticoagulant usage.
4. Patient who is a part of any other study.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Success rate (mean no of attempts ) of conventional versus finger guided
method in nasotracheal intubation.
2) Proportion of patients having epistaxis. |
Epistaxis
baseline immediately after intubation and then 5 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean of haemodynamic variables (HR,MAP,SBP,DBP,SPO2). |
Baseline is noting hemodynamic variables during intubation.Then immediately after intubation & 5 minutes after intubation. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/11/2025 |
| 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="3"
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 randomized comparative study will be conducted at sms medical college and hospital jaipur to assess the success rate and complication of nasotracheal intubation by conventional and finger guided method among patients undergoing maxillofacial surgeries. A total of 70 patients will be enrolled and randomized into two equal groups conventional and finger guided group. Success rate and complication epistaxis between both groups will be compared and assessed. Also hemodynamic parameters at different time intervals will be noted. The aim is to identify the group with less complication of epistaxis and better success rate with stable hemodynamic parameters. |