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A study to see how using Heart- Lung Machine during Heart surgery affects the size of nerve behind the eye in adults.

Effect of extracorporeal circulation on optic nerve sheath diameter in adult patients undergoing cardiac surgery on cardiopulmonary bypass under mild to moderate hypothermia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096347
Enrollment
30
Registered
2025-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system

Interventions

Intervention1: Nil: Nil

Sponsors

Vardhman Mahavir Medical College and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult Patients aged 18-65 years fulfilling the criteria of American Society of Anesthesiologists (ASA) Grade 2 and 3 undergoing cardiac Surgery on cardiopulmonary bypass under mild to moderate hypothermia

Exclusion criteria

Exclusion criteria: 1. Recent history of cerebrovascular accident,or intracranial hypertension due to any cause. 2. Severe psychiatric illness precluding valid consent and neurologic assessment. 3. Active ocular ailments confounding the ONSD measurements. 4.History of opthalmic surgery. 5. Any Carotid Artery Disease. 6. Known allergy to ultrasound conductive gel

Design outcomes

Primary

MeasureTime frame
Mean ONSD measurement of each eye at baseline, 30min, 60min, 90min after CPB , at complete rewarming on CPB, end of surgery.Timepoint: Mean ONSD measurement of each eye at baseline, 30min, 60min, 90min after CPB , at complete rewarming on CPB, end of surgery.

Secondary

MeasureTime frame
Duration of Cardiopulmonary bypass and aortic cross clampTimepoint: It includes baseline value (preinduction time) 30min,60min,90min,at complete rewarming, end of surgery and post operatively.;Hemoglobin, Hematocrit, serum sodium and lactates.Timepoint: It includes baseline value (preinduction time) 30min, 60min, 90min,at complete rewarming, end of surgery and post operatively.;Volume of prime on CPB and total cardioplegia, type of cardioplegiaTimepoint: It includes baseline value (preinduction value) 30min,60min,90min,at complete rewarming,end of surgery and post operatively.;Hemofiltration volume on CPB.Timepoint: It includes baseline value (preinduction value) 30min,60min,90min,at complete rewarming,end of surgery and post operatively.;Adverse neurological events after surgery.Timepoint: It includes baseline value ( preinduction value) 30min,60min,90min,at complete rewarming,end of surgery and post operatively.

Countries

India

Contacts

Public ContactDr Ira Balakrishnan M

VMMC and Safdarjung Hospital

irabala82@gmail.com7838867927

Outcome results

None listed

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