| CTRI Number |
CTRI/2025/09/094006 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparison of modern video technique and traditional method for putting a breathing tube in emergency patients |
|
Scientific Title of Study
|
Comparison of videolaryngoscopy versus conventional laryngoscopy for endotracheal intubation in emergency department - a prospective interventional study |
| 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. Ritu Khandelwal |
| Designation |
Junior Resident Doctor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India.
Wardha
MAHARASHTRA
442107
India |
| Phone |
8269573995 |
| Fax |
|
| Email |
khandelwalr157@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charuta Gadkari |
| Designation |
Professor, Department of Emergency Medicine |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India.
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823017279 |
| Fax |
|
| Email |
charutagadkari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Khandelwal |
| Designation |
Junior Resident Doctor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India.
Wardha
MAHARASHTRA
442107
India |
| Phone |
8269573995 |
| Fax |
|
| Email |
khandelwalr157@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education & Research, (Deemed to be University), Sawangi (Meghe), Wardha - 442107, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Dr Ritu Khandelwal |
| Address |
Room No S2, Radhikabai Girls PG Hostel, Datta Meghe Institute of Higher Education & Research,
(Deemed to be University), Sawangi (Meghe),
Wardha - 442107 Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Datta Meghe Institute of Higher Education Research |
Datta Meghe Institute of Higher Education & Research,
(Deemed to be University), Sawangi (Meghe),
Wardha - 442107 Maharashtra
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Khandelwal |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
Department of Emergency Medicine, Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe),Wardha.Maharashtra 442107
Wardha
MAHARASHTRA |
8269573995
khandelwalr157@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research 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 direct laryngoscopy (Macintosh blade) |
One time oral endotracheal intubation in the ED using a Macintosh direct laryngoscope; performed by the principal investigator with the same pre-oxygenation, RSI care. Bougie or stylet permitted if required. Tube position confirmed with 5-point auscultation, EtCO2 and ultrasound. Outcomes recorded include first-pass success, number of attempts, and time to intubation.Single oral endotracheal intubation episode performed in the ED, expected duration approximately 1–5 minutes per patient until confirmation of tube placement. |
| Intervention |
Videolaryngoscopy-assisted endotracheal intubation |
One time oral endotracheal intubation in the ED using a Sandors videolaryngoscope with appropriate reusable adult blades; performed by the principal investigator after prior training. Standard ED RSI meds and pre-oxygenation as per protocol (not part of the intervention). Bougie or stylet may be used if needed. Tube position confirmed with 5 point auscultation, EtCO2 and ultrasound. Outcomes recorded include first-pass success, number of attempts, and time to intubation.
Single oral endotracheal intubation episode performed in the ED, expected duration approximately 1–5 minutes per patient until confirmation of tube placement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients in need of emergency endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Pregnant females.
Morbidly obese patients.
Refusal to participate in study by relatives.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Attempt is defined as any insertion of either a direct laryngoscope or videolaryngoscope into the patient’s mouth. Number of attempts required for successful intubation will be recorded.
First pass success rate, defined when the blade was applied for the first time and the endotracheal tube was passed through the vocal cords in the same attempt. Incidence of first pass success rate will be recorded.
Time to intubation, defined as the time from when the laryngoscope is first placed into the patient’s mouth until confirmation of ETT on capnography will be recorded
|
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intubation related adverse events, including major and minor adverse events within 30 mins of intubation will be recorded. |
18 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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 Yet Recruiting |
| 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
|
Primary Purpose:
The primary purpose of this study is to compare the effectiveness of videolaryngoscopy and conventional direct laryngoscopy for endotracheal intubation in adult patients presenting to the emergency department. Hypothesis: Videolaryngoscopy and conventional laryngoscopy may show differences in intubation outcomes such as first-pass success rate, number of attempts, time to intubation, and peri-intubation adverse events in the emergency department.
|