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

NCT06595667 | Active Not Recruiting DMC

• 2 other identifiers: ANE-2567-0391Chiang Mai University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Posterior Fossa Tumor; Brain Tumor Adult

Keywords

Parkbench position; posterior fossa tumor; pulse pressure variation; fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• Total intraoperative fluid administration volumes during surgery

  fluid and blood and blood volume transfusion during surgery

  during surgery

Secondary Outcomes (3)

• vital signs

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

• vital signs

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

• time to extubation

  48 hours after surgery at the neurosurgical intensive care unit

Other Outcomes (2)

• vasopressor requirement

  during surgery and 48 hours at the neurosurgical ICU

• length of neurosurgical ICU stay

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

Study Arms (2)

Pulse pressure variation guidance fluid administration

EXPERIMENTAL

In the PPV group, fluids will be administered to maintain the PPV below 13%. If hypotension coincided with a PPV exceeding 13%, an initial bolus of 200 ml crystalloid fluid solution will be given in10 minutes. PPV reassessment occurred within the subsequent 10 minutes. Alternatively, if hypotension occurs with a PPV measuring less than 13%, vasopressors such as ephedrine at a dose of 3-6 mg or norepinephrine at a dosage of 5-10 mcg intravenously as a bolus, or norepinephrine infusion at a rate of 0.03-0.3 mcg/kg/min, will be given to sustain mean arterial pressure above 65 mmHg.

Procedure: Pulse pressure variation

Central venous pressure guidance fluid administration

EXPERIMENTAL

In the CVP group, intraoperative fluid administration aimed to maintain CVP between 8-12 cmH2O while on mechanical ventilation, ensuring mean arterial pressure remains above 65 mmHg and heart rate within 20% of baseline.

Procedure: Central venous pressure

Interventions

Pulse pressure variation PROCEDURE

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

Also known as: PPV

Pulse pressure variation guidance fluid administration

Central venous pressure PROCEDURE

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

Also known as: CVP

Central venous pressure guidance fluid administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• Pin On P, Kacha S, Saringkarinkul A, Thanakititham N. Study protocol for a randomized controlled trial comparing pulse pressure variation (PPV) and central venous pressure (CVP) guidance for fluid responsiveness assessment in neurosurgical patients undergoing posterior fossa tumor resection in park bench position. PLoS One. 2025 Jun 2;20(6):e0324590. doi: 10.1371/journal.pone.0324590. eCollection 2025.

  PMID: 40455866 DERIVED

MeSH Terms

Conditions

Infratentorial Neoplasms

Interventions

Central Venous Pressure

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

Intervention Hierarchy (Ancestors)

Venous Pressure; Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Pathomporn P Pin on, Associate Professor

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor received the anesthetic record form by unknown of the patient and group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pathomporn Pin on

Model Details: Two study groups are parallel according to the block of four randomization.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: September 2, 2024
• Primary Completion: September 20, 2025
• Study Completion: October 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TH (1)