| CTRI Number |
CTRI/2026/02/103521 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical evaluation of a novel 3 in 1 intraoperative protective device for endotracheal tube stabilization during general anesthesia |
|
Scientific Title of Study
|
clinical evaluation of a 3 in 1 intraoperative protective device for endotracheal tube stabilisation for patients undergoing general anaesthesia during surgical procedures A single arm comparative analytical 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 |
Nancy sharma |
| Designation |
post graduate |
| Affiliation |
saveetha institute of medical and technical sciences |
| Address |
saveetha medical college and hospital , saveetha nagar , thandalam kancheepuram district chennai 602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8475020212 |
| Fax |
|
| Email |
drnancy6057073@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
latha narayanan |
| Designation |
professor |
| Affiliation |
saveetha institute of medical and technical sciences |
| Address |
saveetha medical college and hospital saveetha nagar, thandalam chennai 602105 kanchipuram district
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9840125462 |
| Fax |
|
| Email |
lathanarayanan2363@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nancy sharma |
| Designation |
post graduate |
| Affiliation |
saveetha institute of medical and technical sciences |
| Address |
flat no 511 silver oaks alliance orchid springs korattur chennai
Kancheepuram
TAMIL NADU
600079
India |
| Phone |
8475020212 |
| Fax |
|
| Email |
drnancy6057073@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
saveetha medical college |
| Address |
thandalam kancheepuram |
| 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 Nancy sharma |
saveetha medical college and hospital |
department of anaesthesiology and operation theatre complex
Kancheepuram
TAMIL NADU |
8475020212
drnancy6057073@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| saveetha medical college and hospital institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Nil |
| Intervention |
Novel 3-in-1 intraoperative protective device |
A three-in-one intraoperative protective device consisting of an endotracheal tube holder with an integrated bite block and a protective eye piece. This device will be applied to all participants undergoing elective surgical procedures under general anesthesia to secure the airway, prevent tube displacement, protect teeth and lips, and provide eye protection. Outcomes will be assessed intraoperatively, at the end of surgery, and within 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation, ASA physical status I–III, who provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Emergency surgeries
Facial or oral pathology interfering with device placement
Pre-existing ocular injury
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Endotracheal tube stability, assessed by the presence or absence of tube displacement during surgery.
|
intra-operative for tube stability
and at the time of extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of dental, lip, or oral injury
Incidence of bite-related tube obstruction
Incidence of ocular complications
Time taken for device application
Anesthesiologist satisfaction score
|
Intraoperatively, at the end of surgery, and within 24 hours postoperatively
Intraoperatively, at the end of surgery
Intraoperatively, at the end of surgery, and within 24 hours postoperatively
Immediately after induction and device placement
At the end of surgery
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2026 |
| 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)
|
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
|
This is a prospective interventional single-arm clinical study conducted to evaluate a novel three-in-one intraoperative protective device consisting of an endotracheal tube holder with an integrated bite block and protective eye piece. All participants will receive the novel device during elective surgical procedures under general anesthesia. The primary outcome is endotracheal tube stability during surgery. Secondary outcomes include incidence of dental, lip, or oral injury, bite-related tube obstruction, ocular complications, time taken for device application, and anesthesiologist satisfaction. Outcomes will be assessed at baseline before induction, intraoperatively, at the end of surgery, and within twenty-four hours postoperatively. The study aims to assess the safety, feasibility, and effectiveness of the novel device in a single group of patients. |