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To assess the advantages early tracheostomy vis-à-vis late tracheostomy in severe stroke patients admitted at AIIMS Rishikesh medicine ICU.

To Determine 30 Days Outcomes in Early versus Late Tracheostomy in Stroke Patients: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048598
Enrollment
60
Registered
2022-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: G822- Paraplegia Health Condition 2: G825- Quadriplegia Health Condition 3: G811- Spastic hemiplegia

Interventions

Intervention1: tracheostomy: early tracheostomy at day 4 Control Intervention1: tracheostomy: late tracheostomy at day 10

Sponsors

Dr Nitin Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age group 18 years and above. GCS less than equal to 8 or Bulbar palsy (primarily involving cranial nerves IX and X). The patients with Non-traumatic cerebrovascular disease. Severe acute ischemic stroke (e.g. large hemispheric stroke, space-occupying cerebellar stroke, basilar thrombosis, and brain stem infarction), large or brain stem, intracerebral hemorrhage, and intraventricular hemorrhage. SETscore for tracheostomy more than 8

Exclusion criteria

Exclusion criteria: Patients intubated outside AIIMS, Rishikesh. The patients who have already developed aspiration pneumonia, hospital acquired/ventilator associated pneumonia before study enrolment. Artificial ventilation for more than 4 days. Need for a permanent surgical tracheostomy. High oxygenation requirements: Positive end-expiratory pressure > 12, or fraction of inspired oxygen > 0.6). Pregnancy. Participation in any other interventional trial.

Design outcomes

Primary

MeasureTime frame
To determine the effectiveness of early and late tracheostomy in reducing 30 days mortality among stroke patients at medicine ICU.Timepoint: it will be evaluated on 30th day from day of intubation

Secondary

MeasureTime frame
secondary outcome- To estimate the proportion of ventilator associated pneumonia, ventilator free days, and length of ICU stay (in days) in early and late tracheotomised patients.Timepoint: alternate day from day of tracheostomy till 30th day or discharge or demise

Countries

India

Contacts

Public ContactNitin Kumar

AIIMS RISHIKESH

drmukeshbairwa1982@gmail.com8130023989

Outcome results

None listed

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