| CTRI Number |
CTRI/2026/01/100324 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| 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 Methods of Flexible Scope Guided Nasal Breathing Tube Placement to Improve Successful Intubation During elective Surgery |
|
Scientific Title of Study
|
Comparison of Endotracheal Tube as a Conduit Versus the Conventional Technique for Flexible Intubating Video
Endoscope Guided Nasotracheal Intubation, A Randomized Controlled
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 Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Room no - 512, OT complex ,5th Floor ,Dept. of anaesthesiology, All India Institute Of Medical Science, Patna ,Bihar Department Of Anaesthesiology ,All India Institute Of Medical Science, Patna ,Bihar Patna BIHAR 801507 India |
| Phone |
9431857279 |
| Fax |
|
| Email |
rajesh2k3dmc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Room no - 512, OT complex ,5th Floor ,Dept. of anaesthesiology, All India Institute Of Medical Science, Patna ,Bihar Department Of Anaesthesiology ,All India Institute Of Medical Science, Patna ,Bihar Patna BIHAR 801507 India |
| Phone |
9431857279 |
| Fax |
|
| Email |
rajesh2k3dmc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Science |
| Address |
Room no - 512, OT complex ,5th Floor ,Dept. of anaesthesiology, All India Institute Of Medical Science, Patna ,Bihar Department Of Anaesthesiology ,All India Institute Of Medical Science, Patna ,Bihar Patna BIHAR 801507 India |
| Phone |
9431857279 |
| Fax |
|
| Email |
rajesh2k3dmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science ,Patna,Bihar,India Pin Code 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
All India Institute of Medical Science ,Patna, Bihar, India Pin Code 801507 |
| 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 Rajesh Kumar |
All India Institute of Medical Science |
Room no-512, 5th floor, OT complex Department of Anaesthesiology AIIMS,Patna Phulwarisarif, Patna, Bihar Pin - 801507
Patna
BIHAR Patna BIHAR |
09431857279
rajesh2k3dmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Science, Patna |
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 |
| Intervention |
endotracheal tube as conduit technique |
In the endotracheal tube as conduit technique, a properly sized endotracheal tube is first inserted through the selected nostril up to the nasopharynx, and the flexible intubating video endoscope is passed through its lumen. The endoscope is advanced under vision to identify the vocal cords and carina, after which the endotracheal tube is gently railroaded into the trachea. Successful intubation is confirmed by direct visualisation of the carina and the appearance of a consistent end tidal carbon dioxide waveform. |
| Comparator Agent |
standard technique |
In the standard technique, the endotracheal tube is pre mounted over the flexible intubating video endoscope and the combined assembly is introduced through the nostril.The endoscope is advanced under vision through the vocal cords to the carina, after which the endotracheal tube is railroaded into the trachea and the cuff inflated. Correct tube placement is confirmed by direct visualisation of the carina and a consistent end tidal carbon dioxide waveform, with the tube secured 4 cm above the carina |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for elective surgery under general anesthesia require nasal intubation with ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Known bleeding disorders
2.Base of skull fracture or any contraindication to nasal intubation
3.History of drug or latex allergy
4.Uncontrolled hypertension or Diagnosed ischemic heart disease
5.Pregnancy and breast feeding women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total intubation time between the ETT-as-conduit technique and the
conventional method of FIVE-guided nasotracheal intubation. |
To compare the total intubation time between the ETT-as-conduit technique and the
conventional method of FIVE-guided nasotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the hemodynamic variation during the procedure.
2.To compare no of attempt and the incidence of nasal bleeding associated with each technique. |
During surgery |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Nasotracheal intubation using a flexible intubating video endoscope is commonly performed in patients undergoing head and neck and maxilofacial surgeries. However, the technique can be technically challenging and the time-consuming, particularly in patients with limited airspace and difficult anatomy. Various adjuncts have been described to facilitate endoscope guided nasotracheal intubation, including the use of an endotracheal tube as a conduit. This randomised controlled trial aims to compare the effectiveness and safety of using an endotracheal tube as a conduit versus the conventional technique for flexible intubating endoscope-guided nasotracheal intubation in adult patients. Participants will be randomly allocated to one of the two study groups. The primary outcome will be the time required to achieve successful nasotracheal intubation. Secondary outcome will be first attempt success rate ease of intubation, mucosal trauma and bleeding. Successful intubation will be confirmed by the presence of a consistent end tidal carbon dioxide waveform. Failed intubation will be managed according to standard institutional airway management protocols.The finding of the study are expected to provide evidence-based guidance on the optimal technique for flexible endoscope-guided nasotracheal intubation, potentially improving procedural efficiency and patient safety. |