To explore safety and performance of Suction Catheter for removal of secretions from nasal, oro-pharyngeal, tracheo-bronchial regions of the respiratory tract of Adult & Paediatric subjects in Indian Population.
- Conditions
- Health Condition 1: J988- Other specified respiratory disorders
- Registration Number
- CTRI/2022/10/046506
- Lead Sponsor
- Romsons Group Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Males and Females (Adults & Paediatrics) who are expected to require Suction Catheter.
2.Subject who can provide Informed Consent Form (Adult) in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) can provide Informed Assent Form (Child).
3.The subject who is willing and able to comply with the requirement of the follow-up. OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who is willing and able to comply with the requirement of the follow-up.
1.Subject present with medical emergency, where treatment is more priority than the informed consent/informed assent process.
2.Subject with severe health conditions like bleeding disorder, unexplained hemoptysis, severe bronchospasm, irritable airway, facial injury, recent nasal/oral or esophageal surgery, loose teeth/denture, hemodynamic instability, tracheal / esophageal fistulae, severe gag reflex, occluded nasal passage, nasal bleeding, etc.
3.Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc.
4.Any known allergy with any of the material of Suction Catheter and its component(s).
5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his/her participation in, and completion of the clinical investigation plan.
6.Subject who is pregnant or breast feeding.
7.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
8.Participation in another research study involving an active investigation within 30 days prior to consent.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method