| CTRI Number |
CTRI/2025/09/095038 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two devices for breathing tube placement in patients expected to have difficulty during general anesthesia. |
|
Scientific Title of Study
|
Comparison of intubating conditions in difficult airway cases using channeled and non-channeled video laryngoscopes. |
| 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 Naveena Pandiyan |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveena Pandiyan |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raut Akshada Sonba |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Department of Anesthesiology
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU
636308
India |
| Phone |
9082543367 |
| Fax |
|
| Email |
akshadaraut1311@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi, Salem, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Chinnaseeragapadi, Salem, Tamil Nadu, India
Chinnaseeragapadi Salem |
| 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 Raut Akshada Sonba |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi |
Department of Anesthesiology Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi
Salem
TAMIL NADU |
9082543367
akshadaraut1311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 intubation orally using channeled video laryngoscope |
Patient is intubated orally with different sizes of Single oral endotracheal intubation procedure performed once at the time of induction of general anesthesia, using an appropriately sized endotracheal tube guided by a channeled video laryngoscope.
Duration: until successful placement and fixation of the tube (approximately 1–2 minutes). |
| Comparator Agent |
Endotracheal intubation orally using non-channeled video laryngoscope |
Single oral endotracheal intubation procedure performed once at the time of induction of general anesthesia, using an appropriately sized endotracheal tube guided by a non-channeled video laryngoscope. Duration: until successful placement and fixation of the tube (approximately 1–2 minutes). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing general anesthesia
Mallampati grade 3 and 4
American Society of Anesthesiologists Physical Status (ASA-PS) I, II and III |
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologists Physical Status (ASA-PS) IV or higher
Patient refusal
Obstetric patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the duration of intubation time, number of attempts, ease of intubation, visualization of glottis using channeled and non-channeled video laryngoscope in difficult airway cases. |
Duration of intubation time, number of attempts, ease of intubation, visualization of glottis are assessed and recorded immediately at the time of endotracheal intubation(0 minutes). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the complication of intubation like oxygen desaturation, hemodynamic changes, bleeding, bradycardia, hypotension, hypertension using during intubation with channeled & non-channeled video laryngoscope in difficult airway cases. |
Complications are assessed immediately after endotracheal intubation (0 minutes), & then at 1 hour, 2 hours, 3 hours, 4 hours, & 5 hours post-intubation. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
29/09/2025 |
| 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="0"
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 is a prospective, randomized clinical study designed to compare two
types of video laryngoscopes—channeled and non-channeled—in adult patients with
predicted difficult airway undergoing elective surgery under general
anesthesia. The primary objective is to compare intubation difficulty using the
Intubation Difficulty Scale (IDS) between the two devices.
The secondary objective is to compare the incidence of complications
during intubation. All patients will receive standardized anesthetic induction and
maintenance, and intubation will be performed by trained anesthesiologists.
Outcome assessments will be recorded by independent observers. The study aims to determine
whether a channeled or non-channeled video laryngoscope provides superior
intubating conditions in patients with predicted difficult airway.
|