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Gentamycin nebulisation to decrease infection in tracheostomy patients

Nebulized gentamycin for reducing colonisation of tracheostomy tubes: from Neuro ICU to community. A double-blind randomized controlled trial. - CoTiNICU

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041202
Enrollment
70
Registered
2022-03-21
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: G978- Other intraoperative and postprocedural complications and disorders of nervous system Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Nebulisation with Gentamycin: A regime of nebulized gentamicin, in a dose of 80 mg twice daily diluted to 5 ml with 0.9% normal saline for 15 minutes, till death, discharge or 3 tube ch

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Tracheostomised patients in the Neuro surgical ICU expected to survive to home discharge or 7 days post tracheostomy, whichever is greater

Exclusion criteria

Exclusion criteria: 1 Creatinine clearance 2 Vestibular instability/ hearing impairment. 3 Allergic to aminoglycosides. 4 Asthmatic patients. 5 H/o myasthenia gravis.

Design outcomes

Primary

MeasureTime frame
Compare the rates and change in the nature of pathogenic colonization of TT over the course of treatment from the ICU to home care: gentamicin group vs saline nebulization group.Timepoint: 48 hrs, 7, 30 and 60 days after tracheostomy

Secondary

MeasureTime frame
complications and risk factors associated with drug resistant colisationTimepoint: 48 hrs, 7,30 and 60 days after tracheostomy

Countries

India

Contacts

Public ContactSwagata Tripathy

AII India Institute of Medical Sciences

tripathyswagata@gmail.com08763400534

Outcome results

None listed

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