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Measurement of brain oxygen levels before and after head bone removal surgery in patients with major block in brain blood supply and outcome assessment

Prognostic value of regional cerebral oxygen saturation pre and post decompressive craniectomy in patients with malignant anterior circulation ischemic stroke - prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029842
Enrollment
30
Registered
2020-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

NIMHANS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Emergency decompressive craniectomy in patients with anterior circulation ischemic stroke - Middle cerebral artery (MCA) or internal carotid artery (ICA) ischemic stroke.

Exclusion criteria

Exclusion criteria: 1. Patients who are hemodynamically unstable (i.e systolic blood pressure 2. Preoperative peripheral oxygen saturation (SPO2) 3. Patients diagnosed with Posterior cerebral artery infarcts 4. Denial of the consent 5. Preoperative baseline values if not recordable (due to scalp hematoma, thick bone, pigmentation etc)

Design outcomes

Primary

MeasureTime frame
1.To observe the correlation between the baseline rSO2 values rSO2 Ipsilateral i.e. affected hemicranium (rSO2I) and rSO2 Contralateral i.e. unaffected hemicranium (rSO2C) and the hemicranial rSO2 difference with the severity of the stroke (as assessed by NIHSS and GCS) 2.To observe the correlation between the baseline rSO2 (rSO2I and rSO2C) values and the hemicranial rSO2 difference with the 30 day outcome (GCS, GOS, modified Rankin Score, mortality) Timepoint: Baseline, Post operative day 1 and day 30

Secondary

MeasureTime frame
1.Effect of decompressive craniectomy on the changes in rSO2(rSO2I and rSO2C) and the hemicranial rSO2 difference 2.To correlate post-decompressive craniectomy rSO2(rSO2I and rSO2C) and hemicranial rSO2 difference changes with the post-operative day one NIHSS score and 30day outcome Timepoint: NIHSS score on post operative Day 1 and modified rankin score or Glasgow outcome scale day 30 after surgery

Countries

India

Contacts

Public ContactDr Rohini M Surve

National Institute of Mental Health and Neurosciences (NIMHANS)

rohinigondhule@gmail.com9480829846

Outcome results

None listed

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