| CTRI Number |
CTRI/2024/05/068087 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods of putting a tube through nose into the windpipe during general anesthesia a pilot study |
|
Scientific Title of Study
|
Comparison of flexible bronchoscope guided nasotracheal intubation with videolaryngoscopic nasotracheal intubation after induction of general anesthesia in patients with normal airway: A single-blinded pilot randomised 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 Sandipan Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
| Address |
4th floor OT complex
Department of Anesthesia Critical Care and Pain
Mahamana Pandit Madan Mohan Malviya Cancer Centre Sunder Bagiya BHU campus
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9830994628 |
| Fax |
|
| Email |
sandipanb24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandipan Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
| Address |
4th floor OT complex
Department of Anesthesia Critical Care and Pain
Mahamana Pandit Madan Mohan Malviya Cancer Centre Sunder Bagiya BHU campus
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9830994628 |
| Fax |
|
| Email |
sandipanb24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandipan Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
| Address |
4th floor OT complex
Department of Anesthesia Critical Care and Pain
Mahamana Pandit Madan Mohan Malviya Cancer Centre Sunder Bagiya BHU campus
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9830994628 |
| Fax |
|
| Email |
sandipanb24@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Mahamana Pandit Madan Mohan Malviya Cancer Centre,
Sunder Bagiya, BHU campus, Varanasi Uttar Pradesh 221005 India |
|
|
Primary Sponsor
|
| Name |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
| Address |
Sunder Bagiya BHU campus Varanasi 221005 Uttar Pradesh 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 Sandipan Banerjee |
Mahamana Pandit Madan Mohan Malviya Cancer Centre |
4th Floor OT complex Department of Anesthesiology, Critical Care and Pain. Mahamana Pandit Madan Mohan Malviya Cancer Centre Sunder Bagiya BHU campus, PIN 221005
Varanasi
UTTAR PRADESH |
9830994628
sandipanb24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE AND HOMI BHABHA CANCER HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasotracheal intubation using Flexible bronchoscope FB group |
After induction of general anesthesia as per routine protocol, patients enrolled in Group FB will be intubated through the nasotracheal route using a flexible bronchoscope (Ambu® aScope TM 4 Broncho Slim 3.8/1.2). In case intubation is not achieved within 3 minutes or the patient’s oxygen saturation falls below 95%, the intubation attempt using FB will be abandoned and mask ventilation resumed. The airway will then be secured using direct laryngoscopy/video laryngoscopy/ alternative methods like supraglottic airways or awakening the patient followed by FB-guided awake intubation.
Frequency - Once , only during intubation of the patient
Route of administration - Induction drugs will be given by intravenous route, endo tracheal tube will be given through nasotracheal route
Total duration of such intervention- Approximately 10 minutes( induction and intubation phase of anesthesia)
|
| Comparator Agent |
Nasotracheal intubation using video laryngoscope VL group |
After induction of general anesthesia as per routine protocol, patients enrolled in the VL group will be intubated through the nasotracheal route using videolaryngoscope (C- MAC, Karl Storz Endoskope). In case intubation is not achieved within 3 minutes or the patient’s oxygen saturation falls below 95%, the intubation attempt using a video laryngoscope will be abandoned and mask ventilation resumed. The airway will then be secured using direct laryngoscopy or alternative methods like supraglottic airways or awakening the patient followed by FB-guided awake intubation.
Frequency - Once , only during intubation of the patient
Route of administration - Induction drugs will be given by intravenous route, endo tracheal tube will be given through nasotracheal route
Total duration of such intervention- Approximately 10 minutes( induction and intubation phase of anesthesia)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate and sign the informed consent form
2. Age-18 years to 65 years
3. ASA 1 and 2 patients
4. Both sexes
5. Inter-incisor distance greater than three fingers
6. Thyromental distance ≥ 6.5 cm
Normal range of neck movements.
7. Patients posted for surgery who require
nasotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
1. Patients with an anticipated difficult airway.
2. Patients having contraindications for
nasotracheal intubation
3. Pregnant patients.
4. Mentally challenged patients unable to
understand and give informed risk consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ratio of successful nasotracheal intubation by FB compared to videolaryngoscopic nasotracheal intubation |
following induction of general anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time requirement for the successful intubation
2. Number of attempts required for successful intubation
3. Requirement of manoeuvres like jaw thrust, tongue traction, neck extension or backward, upward, and posterior pressure (BURP) on the larynx.
4. Type of complications – trauma, bleeding.
5. Difficulty in visualization of the airway due to airway collapse.
6. Mechanical obstruction during the passage of the endotracheal tube into the trachea.
7. Use of additional airway instruments to aid endotracheal intubation.
8. Hemodynamic parameters (heart rate and blood pressure) at baseline prior to the induction of anesthesia, pre-intubation, and post-intubation.
|
following induction of general anesthesia |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
05/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Endotracheal
intubation is a crucial step in patients undergoing surgery under general
anesthesia. There are many ways to intubate the trachea, the commonest of which
include direct laryngoscopy, video laryngoscopy and flexible bronchoscope (FB) guided intubation.
Awake FB-guided
intubation is the gold standard and preferred way to secure the trachea in
cases of anticipated difficult airway. However, FB-guided intubation after general anesthesia is
not frequently chosen by anesthesiologists in day-to-day practice although its
use is mentioned in unanticipated difficult airway guideline. [1]
Under
general anesthesia, muscle tone is reduced which makes upper airway structures collapse
and fall towards the posterior pharyngeal wall. [2-3] This may make
the airway potentially difficult for FB-guided intubation after induction of general anesthesia. In a
previous study, where FB-guided
orotracheal intubation after general anesthesia was evaluated, the
aforementioned problem was prevented by applying jaw thrust and lingual
traction. [4] Nasotracheal intubation is a commonly performed procedure
to secure the airway during surgeries involving the oral cavity. It is usually
done by direct or video laryngoscopy which carries the added risk of trauma
related to direct instrumentation. Blind introduction of an endotracheal tube
through the nostrils can lead to the avulsion of nasal spur/ polyp or
mechanical obstruction. Using a FB for nasotracheal intubation helps in the evaluation of the
passage prior to the introduction of the endotracheal tube and can avert
complications associated with the blind introduction.
We
hypothesize that in an airway not anticipated to be difficult, FB-guided nasotracheal
intubation after induction of general anesthesia will be better compared to the
videolaryngoscopic intubation in terms of improved success rate, a lesser
degree of airway trauma and lesser added instrumentation. FB-guided nasotracheal intubation may also be
associated with a lesser surge in blood pressure and heart rate usually
associated with laryngoscopy and intubation. Though airway collapse may
interfere with the advancement of the bronchoscope, choosing the nasotracheal
route might help in better alignment of airway axes leading to a higher success
rate of endotracheal intubation. |