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To evaluate the effect of removing the skull bone on brain oxygenation in head injury patients.

To evaluate the effect of decompressive craniectomy on cerebral venous oxygen saturation (SjVO2) in traumatic brain injury patients - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/081341
Enrollment
30
Registered
2025-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: S062- Diffuse traumatic brain injury

Interventions

None listed

Sponsors

AIIMS, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-65 yrs 2.Either sex 3.ASA Physical status I/II/III 4.Patient admitted within 48hrs of TBI 5.Moderate to severe TBI (GCS = 12 after resuscitation)  6.Patients undergoing invasive ICP monitoring with a sustained rise in ICP refractory to medical management.

Exclusion criteria

Exclusion criteria: 1.ASA physical status IV/ V 2.Any brain mass lesion requiring immediate 3.decompression 4.Patients with dilated unreactive pupils 5.Non-traumatic intracranial mass lesion 6.Past H/o any intracranial surgery 7.Coagulation abnormality 8.Unstable cervical spine injury 9.Pregnant and lactating patients

Design outcomes

Primary

MeasureTime frame
To compare jugular venous oximetry values before and after decompressive craniectomy (DC)Timepoint: multiple readings will be taken at multiple timepoints starting before DC to 24 hours after DC.

Secondary

MeasureTime frame
To correlate the lowest values of SjVO2 with the outcome (GOSE) at discharge and at 3 months To correlate changes in values of SjVO2 with outcome (GOSE) at discharge and at 3 months To correlate values of SjVO2 and ICP (pre- and post-decompressive craniectomy) To correlate changes in AVDO2, AVDG and VADL values with the outcome (Pre-operative, Intra-operative just after the dural opening, and post-operative at 1, 6 & 24 h) Timepoint: Multiple readings will be taken at multiple timepoints starting before DC to 24hrs after DC

Countries

India

Contacts

Public ContactDr Navdeep Sokhal

AIIMS New Delhi

drnavdeepsokhal@gmail.com9953279619

Outcome results

None listed

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