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

Not Applicable

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2020/12/029842
• Lead Sponsor: IMHANS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-12-31
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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

1. Patients who are hemodynamically unstable (i.e systolic blood pressure <90 mm Hg or mean blood pressure <60mmHg)) despite fluid resuscitation or requiring vasopressor/Inotropic support prior to induction of anaesthesia

2. Preoperative peripheral oxygen saturation (SPO2) <92%

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) <br/ ><br>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) <br/ ><br> <br/ ><br>Timepoint: Baseline, Post operative day 1 and day 30 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Effect of decompressive craniectomy on the changes in rSO2(rSO2I and rSO2C) and the hemicranial rSO2 difference <br/ ><br>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 <br/ ><br>Timepoint: NIHSS score on post operative Day 1 and modified rankin score or Glasgow outcome scale day 30 after surgery