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“TO SEE THE EFFECTS OF LOW BODY TEMPERATURE AND DURATION OF HEART-LUNG BYPASS ON OXYGEN SUPPLY OF BRAIN AS SHOWN BY A SPECIAL MONITOR-NIRS

“TO EVALUATE THE EFFECTS OF TEMPERATURE AND DURATION OF CARDIOPULMONARY BYPASS ON CEREBRAL SATURATION DURING OPEN HEART SURGERIES BY USING NEAR INFRARED SPECTROSCOPY AND ITS CLINICAL CORRELATION WITH POST OPERATIVE NEUROLOGICAL OUTCOMES ? - NICCO TT TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/10/015909
Enrollment
60
Registered
2018-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

None listed

Interventions

None listed

Sponsors

DR Ram Manohar Lohia Institute Of Medical Sciences
Lead Sponsor
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Informed written consent. 2.Patients between 18-60 years of age of either sex. 3.Patients undergoing open heart surgeries on cardio pulmonary bypass.

Exclusion criteria

Exclusion criteria: 1.Patient’s refusal to participate in the study. 2.Patients with pre-existing neurocognitive dysfunction. 3.Patients with a history of symptomatic cerebrovascular disease. 4.Deep hypothermic cardiac arrest. 5.CPB temperature less than 28?. 6.Anaemia with haematocrit 7.Patients with atheromatous plaque in carotid arteries, stenosis of carotid arteries, clot in left atrium or left ventricle.

Design outcomes

Primary

MeasureTime frame
To see the effect of temperature and duration of cardiopulmonary bypass on cerebral saturation(rScO2) using NIRSTimepoint: Time points of measurement of rScO2: 1.Before induction(BI) 2.15 minutes after induction 3.On CPB, every 5 minutes 4.Immediate post CPB 5.At arrival in post operative ICU—

Secondary

MeasureTime frame
2. To see the clinical correlation of neurological outcomes in post operative period with cerebral saturation in the intra-operative period.Timepoint: OUTCOME VARIABLES- 1. Clinical diagnosis of stroke or encephalopathy; 2. Western Perioperative Neurologic Scale (WPNS). 3.Trail making Test A (TTA) 4. Mini Mental State Examination (MMSE). Time points for measurement of neurocognitive functions: 1. Pre-operative 2. Post-extubation 3. 24 hrs post-extubation 4. On the day of discharge 5. One month after surgery 6. Six months after surgery—

Countries

India

Contacts

Public ContactAshish GUPTA

DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES

drdas_73@rediffmail.com7275068939

Outcome results

None listed

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