Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: Suction Catheter (Suction Catheter-Plain GS-2006, Suction Catheter-Cee Tee Cath-TC(Thumb Control GS-2007 TC), Suction Catheter-FT (Finger Tip Control) GS-2022 & GS-2023, Suction Cathete
Sponsors
Romsons Group Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Completion of Performance TimelineTimepoint: Instant Use/ Transient Use - less than 60 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Anoop Batra
Romsons Group Private Limited
Outcome results
None listed