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clinical evaluation of a novel 3 in 1 intraoperative protective device for endotracheal tube stabilization during general anesthesia

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103521
Enrollment
60
Registered
2026-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Intervention1: 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 e

Sponsors

saveetha medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation, ASA physical status I III, who provide written informed consent.

Exclusion criteria

Exclusion criteria: Anticipated difficult airway Emergency surgeries Facial or oral pathology interfering with device placement Pre-existing ocular injury

Design outcomes

Primary

MeasureTime frame
Endotracheal tube stability, assessed by the presence or absence of tube displacement during surgery. Timepoint: intra-operative for tube stability and at the time of extubation

Secondary

MeasureTime frame
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 Timepoint: 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

Countries

India

Contacts

Public ContactNancy sharma

saveetha institute of medical and technical sciences

lathanarayanan2363@gmail.com9840125462

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026