| CTRI Number |
CTRI/2025/08/093516 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| 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
|
Improving Intubation Time for Awake Nasotracheal Procedures: A Comparative Study
|
|
Scientific Title of Study
|
Comparison of intubation time using split nasopharyngeal airway as conduit and conventional method for awake video endoscope guided nasotracheal intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Meena |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,VMMC and Safdarjung Hospital, Ansari Nagar East,New Delhi
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
7217742533 |
| Fax |
|
| Email |
17rekhameena1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shipra Aggarwal |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,VMMC and Safdarjung Hospital, Ansari Nagar East,New Delhi
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
shipra.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra Aggarwal |
| Designation |
Consultant and Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,VMMC and Safdarjung Hospital, Ansari Nagar East,New Delhi
New Delhi
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
shipra.mamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical college and Safdarjung Hospital,
New Delhi
110029
India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical college and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical college and Safdarjung Hospital,Ansari Nagar West, New Delhi110029, India
110029 |
| 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 Rekha Meena |
VMMC and Safdarjung Hospital , New Delhi, India |
Department of Anaesthesia and Intensive , Main OT Block
DELHI
New Delhi
DELHI |
7217742533
01126165060
17rekhameena1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T889||Complication of surgical and medical care, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Awake Flexible Videoendoscopic Nasotracheal intubation with Split Nasopharyngeal Airway
|
In the intervention group, selected patients will undergo awake flexible videoendoscopic intubation using splitnasopharyngeal airway as a conduit after standardized pre-operative preparation. Appropriately sized, well lubricated Split nasopharyngeal airway will be inserted in the selected nostril. Video endoscope will be inserted via the airway and advanced/manipulated till vocal cords are visualized. After appropriate topicalization, scope will be adavanced beyond the glottis till the carina is visualized. The split nasopharyngeal airway will then be peeled off by an assistant. Approriately sized cuffed endotracheal tube will be railroaded over the scope. After cuff inflation, the scope will be withdrawn and position of the tube confirmed via capnography and auscultation.
Duration of Intervention: The split nasal airway will be in-situ from the start of flexible videoendoscopy till the time operator has visualized and topicalized the carina. |
| Comparator Agent |
Conventional Awake Flexible Videoendoscopic Nasotracheal intubation without Nasopharyngeal Airway |
In the comparator group, selected patients will undergo conventional awake flexible videoendoscopic intubation after standardized pre-operative preparation. Video endoscope will be inserted in the selected nostril and advanced/manipulated till vocal cords are visualized. After appropriate topicalization, scope will be adavanced beyond the glottis till the carina is visualized. Approriately sized cuffed endotracheal tube will be railroaded over the scope. After cuff inflation, the scope will be withdrawn and position of the tube confirmed via capnography and auscultation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2 patients for elective surgery requiring awake video endoscope guided nasotracheal intubation |
|
| ExclusionCriteria |
| Details |
1. Patients with known coagulation disorders
2. Contraindication for nasal instrumentation
3. Pregnancy
4. Patients with obesity
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the intubation time as time from introduction of video endoscope into nasal
passage till endotracheal cuff inflation using split nasopharyngeal airway as a conduit and
conventional method for awake video endoscope guided nasotracheal intubation. |
Measurement:
Intubation time is defined as the duration from the introduction of the video endoscope into the nasal passage until endotracheal cuff inflation.
Time Points:
Start Time: Introduction of the video endoscope into the nasal passage.
End Time: Endotracheal tube cuff inflation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the use of split nasopharyngeal airway as a conduit & conventional method for awake video endoscope guided nasotracheal intubation regarding:
1.Time taken for glottic visualization
2.Ease of insertion by a 3 point ordinal scale
3.Haemodynamic changes including HR, SBP, DBP, MBP, oxygen saturation
4.Cough Scale by Helbo-Hansen Cough Scale |
Measurement:
Time taken for Glottic Visualization This duration is defined as the time from the introduction of the video endoscope into the nasal passage until the glottis is visualized on the monitor.
Time Points:
Start Time: Introduction of the video endoscope into the nasal passage.
End Time: Visualization of the glottis. |
|
|
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)
|
17/09/2025 |
| 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="1"
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 compares two techniques for performing awake nasotracheal intubation using a video endoscope. Conventional method is standard technique without any adjunct airway device.Split Nasopharyngeal Airway (SNPA) as a Conduit is a modified airway device inserted into the nasal passage to guide the endoscope and endotracheal tube more efficiently.The primary objective is to assess and compare the intubation time between the two methods. Secondary outcomes may include patient comfort, ease of intubation, complication rates, and visualization quality. |