Clinical trial · Interventional
The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery
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
NCT04232059CI-TRIAL-00056911completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniotomy | — | UNRESOLVED | — |
| Hyperventilation | — | UNRESOLVED | — |
| Infratentorial Neoplasms | Infratentorial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cerebral oximetry | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1: hyperventilation
- description
- • Group 1: hyperventilation (ETco2 25-30 mm Hg) for 20 minutes that will start immediately after skin incision followed by normoventilation (ETco2 31-35 mm Hg) for another 20 minutes.
- interventionNames
- Device: cerebral oximetry
- type
- ACTIVE_COMPARATOR
- label
- Group 2: normoventilation
- description
- • Group 2: normoventilation (ETco2 31-35 mm Hg) for 20 minutes immediately after skin incision followed by hyperventilation (ETco2 25-30 mm Hg) for another 20 minutes.
- interventionNames
- Device: cerebral oximetry
Primary outcomes (1)
- measure
- NIRS value at the end of phase 1 assessment in each group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 6 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.