A clinical study to analyze the safety and effectiveness of Endotracheal tube ( device intubated into the trachea for provision of mechanical ventilation, For maintaining an open airway) during anesthesia or ventilation procedures.

A prospective, single arm, post market clinical follow-up study of Endotracheal Tube to evaluate safety and performance in Indian population.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/01/022807

Enrollment

100

Registered

2020-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: Z758- Other problems related to medicalfacilities and other health care

Interventions

Intervention1: Endotracheal Tube: Endotracheal Tube Plain (GS-2002), Endotracheal Tube Cuffed (GS-2004), Re-inforced Endotracheal Tube (GS-2013) Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and Females above 18 year expected to require mechanical ventilation. 2. Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process. 3. The subject is willing and able to comply with the requirement of the study protocol.

Exclusion criteria

Exclusion criteria: 1. Subject who present with medical emergency, where treatment is more priority than the informed consent process. 2. Subject, who cannot provide informed consent in general such as unconscious, mentally challenged patient, vulnerable subject etc. 3. Allergy with any of the material of Endotracheal Tube and its component. 4. Subject who is pregnant or breastfeeding. 5. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 6. Participation in another research study involving an investigational agent within 30 days prior to consent.

Design outcomes

Primary

Measure	Time frame
successful completion of performance timelineTimepoint: 1. Less than 24 hours 2. Greater than 24 hours	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactMr Vijay Arora

Romsons Scientific & Surgical Industries Pvt. Ltd.

cro@romsons.com8574610157

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026