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

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ClinicalTrials.gov Identifier: NCT04232059
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital

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.

Condition or disease Intervention/treatment Phase
Infratentorial Neoplasms Hyperventilation Craniotomy Device: cerebral oximetry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : May 1, 2021

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Arm Intervention/treatment
Active Comparator: Group 1: hyperventilation
• 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
evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.

Active Comparator: Group 2: normoventilation
• 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
evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.




Primary Outcome Measures :
  1. NIRS value at the end of phase 1 assessment in each group [ Time Frame: 20 minutes after skin incision ]
    NIRS value at the end of phase 1 assessment in each group


Secondary Outcome Measures :
  1. - Brain relaxation score [ Time Frame: 20 minutes after skin incision ]

    Brain relaxation score: four-point scale as follows:

    1. Excellent with no swelling
    2. Minimal swelling, acceptable
    3. Swollen but no treatment required
    4. Swollen, needing treatment. the higher the score the higher the intracranial pressure

  2. - Subdural intracranial pressure (ICP) [ Time Frame: Subdural ICP every 2 minutes during each phase of the study (40 minutes) ]
    - Subdural intracranial pressure (ICP)



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232059


Locations
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Egypt
Kasralainy Recruiting
Cairo, Egypt, 11559
Contact: Khaled Sarhan, MD    +201020067816    khaled.sarhan@kasralainy.edu.eg   
Sponsors and Collaborators
Kasr El Aini Hospital

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Responsible Party: Khaled Abdelfattah Abdallah Sarhan, lecturer of anesthesia, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04232059    
Other Study ID Numbers: MD-X-2020
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital:
posterior fossa
cerebral oximetry
hyperventilation
children
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Hyperventilation
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases