| CTRI Number |
CTRI/2025/02/080781 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between cuff inflation method with neck flexion versus conventional method for nasotracheal intubation using a video laryngoscope |
|
Scientific Title of Study
|
Comparison between cuff inflation technique with neck flexion versus conventional technique to aid nasotracheal intubation using video-laryngoscope - A randomised 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 |
Kishore B J |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Anesthesiology, Jawaharlal Nehru Medical College, Nehrunagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9972431072 |
| Fax |
|
| Email |
kishore.jayaprakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra H Kalal |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Anesthesiology, Jawaharlal Nehru Medical College, Nehrunagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880712568 |
| Fax |
|
| Email |
dr.raghavendra.kalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghavendra H Kalal |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Department of Anesthesiology, Jawaharlal Nehru Medical College, Nehrunagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880712568 |
| Fax |
|
| Email |
dr.raghavendra.kalal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Prabhakar Kore Hospital, NehruNagar, Belagavi -590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Nehrunagar, Belagavi - 590010 |
| 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 Kishore B J |
Dr Prabhakar Kore Hospital |
Department of Anesthesiology, JNMC campus, Nehrunagar, Belagavi
Belgaum
KARNATAKA |
9972431072
kishore.jayaprakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional technique |
Using Magills forceps to aid nasotracheal intubation using a North polar tube |
| Intervention |
cuff inflation technique with neck flexion |
Using cuff inflation technique with neck flexion to aid nasotracheal intubation using a North polar tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grades 1 and 2, Elective surgeries under general anesthesia requiring nasotracheal intubation, Mouth opening more than 5 cm, Provides consent for the study |
|
| ExclusionCriteria |
| Details |
Contraindication to general anesthesia and nasotracheal intubation, Refusal to provide consent for the study, Emergency surgery, Mouth opening less than 5 cm, Nasal trauma or bleed |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare ease of nasotracheal intubationusing cuff inflation technique with neck flexion versus conventional technique using a magills forceps |
Procedure will be completed within 120 seconds. If it exceeds 120 seconds, the study will be abandoned in view of patient safety |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="6"
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 aims to assess the ease and safety during nasotracheal intubation using cuff inflation technique along with neck flexion which is relatively safer than using a magills forceps with may cause trauma to oropharyngeal mucosa and also may tear the tube cuff. This study also helps to asses the time consumed with both the techniques and thus guide regarding which method offers faster intubation. |