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NCT Number: NCT06595667

Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance

To answer the question: What are the differences in intraoperative fluid administration volumes between PPV and CVP-guided strategies during posterior fossa tumor resection in the park bench position?

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Posterior Fossa Tumor Brain Diseases Brain Neoplasms Brain Tumor Adult Central Nervous System Diseases Central Nervous System Neoplasms Infratentorial Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chiang Mai University

Chiang Mai, 50200, Thailand

About this study

Prospective RCT is conducted to compared the amount of fluid volume in adult patients undergoing posterior fossa surgery in park bench position.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 18 years and above
  • American Society of Anesthesiologists (ASA) I and II
  • Diagnosis of posterior fossa tumor requiring surgical resection in the park bench position, under general anesthesia at our hospital
  • Willing to participate in the study

Exclusion criteria

  • Arrhythmia
  • Significant cardiac diseases
  • Chronic obstructive airway disease
  • Elevated intra-abdominal pressure
  • Tumors prone to precipitate diabetes insipidus
  • Peripheral vascular disease
  • Pulmonary hypertension
  • Patients in sepsis

Treatment and study plan

Pulse pressure variation

Procedure

Fluid administration during posterior fossa surgery in the parkbench position is guided by the PPV value.

Other names: PPV

Central venous pressure

Procedure

Fluid administration during posterior fossa surgery in the parkbench position is guided by the CVP value.

Other names: CVP

Primary outcomes

  1. Total intraoperative fluid administration volumes during surgery

    Time frame: during surgery

    fluid and blood and blood volume transfusion during surgery

Secondary outcomes

  1. vital signs

    Time frame: during surgery, the data will be recorded every 5 minutes throughout the procedure

    blood pressure both systolic and diastolic pressure

  2. vital signs

    Time frame: during the admission in neurosurgical ICU up to 3 days after surgery

    blood pressure both systolic and diastolic pressure

  3. time to extubation

    Time frame: 48 hours after surgery at the neurosurgical intensive care unit

    to be able to succesfully extubated, count time period of using ventilator

Other outcomes

  1. vasopressor requirement

    Time frame: during surgery and 48 hours at the neurosurgical ICU

    type and amount of vasoactive medication

  2. length of neurosurgical ICU stay

    Time frame: from date of randomization to the day of being discharged from ICU or up to 1 week after surgery, depended on which happen first

    days of ICU stay

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

Fluid Responsiveness Assessment in Adult Neurosurgical Patients Undergoing Posterior Fossa Tumor Resection in the Park Bench Position: a Comparison Between Pulse Pressure Variation (PPV) and Central Venous Pressure (CVP) Guidance

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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