The Effect of Different Ventilation Strategies on Cerebral Oxygenation Using Near Infrared Spectroscopy (NIRS) in Pediatrics Undergoing Posterior Fossa Tumor Surgery

NCT04232059 | Completed

• 1 other identifier: MD-X-2020
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Infratentorial Neoplasms; Hyperventilation; Craniotomy

Keywords

posterior fossa; cerebral oximetry; hyperventilation; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• - Brain relaxation score

  20 minutes after skin incision

• - Subdural intracranial pressure (ICP)

  Subdural ICP every 2 minutes during each phase of the study (40 minutes)

Study Arms (2)

Group 1: hyperventilation

ACTIVE COMPARATOR

• 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.

Device: cerebral oximetry

Group 2: normoventilation

ACTIVE COMPARATOR

• 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.

Device: cerebral oximetry

Interventions

cerebral oximetry DEVICE

evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.

Group 1: hyperventilation; Group 2: normoventilation

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Age : 1 to 6 years old
• Both sexes
• ASA I-II
• scheduled for posterior fossa tumor resection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Infratentorial Neoplasms; Hyperventilation

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 7, 2022

Record last verified: 2021-03

Locations

EG (1)