To make a new, easy to use tracheostomy tube suction device and to clinically validate its efficacy

Device fabrication and clinical validation of a novel mechanical handheld suction device for tracheostomy tube cleaning: A pilot study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064922

Enrollment

150

Registered

2024-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: J399- Disease of upper respiratory tract, unspecified

Interventions

Intervention1: Tracheostomy tube suction device formulation and clinnical validation: A tracheostomy tube suction device will be formulated and the efficacy will be tested on the patients of all age g

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing to participate in the study. 2. Any age or gender. 3. Tracheostomized for more than 48 hours.

Exclusion criteria

Exclusion criteria: 1. VERY SICK PATIENT ON MECHANICAL VENTOLATOR SUPPORT 2. UNCONSIOUS PATIENTS 3. NOT WILLING TO PARTICIPATE IN STUDY

Design outcomes

Primary

Measure	Time frame
A novel mechanical hand held simple suction device will be formulated and clinically testedTimepoint: A novel mechanical hand held simple suction device will be formulated and clinically tested at 5 different occasions in each patient. It will be done after 2 days of usage.	—

Secondary

Measure	Time frame
1. To measure the negative pressure created in already existing suction devices 2. to validate the clinical efficacy of the three sizes- small medium and largeTimepoint: this is targeted to be done in 1.5 years	—

Countries

India

Contacts

Public ContactDr. Ritu Dudi

AIIMS, NEW DELHI

sagardrprem@gmail.com9868078734

Outcome results

None listed

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