Craniotomy Clinical Trial
Official title:
The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery: Randomized Controlled Cross Over Study
Verified date | March 2021 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.
Status | Completed |
Enrollment | 42 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 6 Years |
Eligibility | Inclusion Criteria: - Age : 1 to 6 years old - Both sexes - ASA I-II - scheduled for posterior fossa tumor resection. Exclusion Criteria: - Age < 1 year or > 6 years old - Comorbid condition (ASA classification > II) - patient with anemia (Hb <10 g/dl) - Emergency surgery - Patients with VP shunt, on diuretics, recurrent tumors, cerebral infarction and or hemorrhage - Patients on cardiovascular support e.g.:, inotrope or vasoconstrictor infusions |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasralainy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NIRS value at the end of phase 1 assessment in each group | NIRS value at the end of phase 1 assessment in each group | 20 minutes after skin incision | |
Secondary | - Brain relaxation score | Brain relaxation score: four-point scale as follows:
Excellent with no swelling Minimal swelling, acceptable Swollen but no treatment required Swollen, needing treatment. the higher the score the higher the intracranial pressure |
20 minutes after skin incision | |
Secondary | - Subdural intracranial pressure (ICP) | - Subdural intracranial pressure (ICP) | Subdural ICP every 2 minutes during each phase of the study (40 minutes) |
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