Posterior Fossa TumorNCT06595667
Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance
A study testing Pulse pressure variation and Central venous pressure in people with Posterior Fossa Tumor and Brain Tumor Adult, run by Chiang Mai University at 1 site in Thailand.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Fossa Tumor, Brain Tumor Adult
- What is being tested?
- Pulse pressure variation and Central venous pressure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 2 Sep 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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?
Read the detailed description
Prospective RCT is conducted to compared the amount of fluid volume in adult patients undergoing posterior fossa surgery in park bench position.
- Conditions
- Posterior Fossa Tumor, Brain Tumor Adult
- Being tested
- Pulse pressure variation, Central venous pressure
- Keywords
- Parkbench position, posterior fossa tumor, pulse pressure variation, fluid responsiveness
- Medical subject headings
- Infratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse pressure variationProcedure or surgery
Also called PPV
Fluid administration during posterior fossa surgery in the parkbench position is guided by the PPV value.
Central venous pressureProcedure or surgery
Also called CVP
Fluid administration during posterior fossa surgery in the parkbench position is guided by the CVP value.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Central venous pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative fluid administration volumes during surgery
fluid and blood and blood volume transfusion during surgery
Measured: during surgery
Secondary outcomes (3)
vital signs
blood pressure both systolic and diastolic pressure
Measured: during surgery, the data will be recorded every 5 minutes throughout the procedure
vital signs
blood pressure both systolic and diastolic pressure
Measured: during the admission in neurosurgical ICU up to 3 days after surgery
time to extubation
to be able to succesfully extubated, count time period of using ventilator
Measured: 48 hours after surgery at the neurosurgical intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Sep 2024
- Primary completion20 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Fossa TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups are parallel according to the block of four randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pathomporn Pin on, M.D., Chiang Mai University
- Investigators
- Pathomporn P Pin on, Associate Professor, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595667
- Sponsor's protocol ID
- ANE-2567-0391
- Other IDs
- Chiang Mai University
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40455866
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06595667
- Acronym / sponsor ID
- ANE-2567-0391
- Conditions
- Posterior Fossa Tumor, Brain Tumor Adult
- Keywords
- Parkbench position, posterior fossa tumor, pulse pressure variation, fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Prospective RCT is conducted to compared the amount of fluid volume in adult patients undergoing posterior fossa surgery in park bench position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two study groups are parallel according to the block of four randomization.
| Arm | Type | Receives |
|---|---|---|
| Pulse pressure variation guidance fluid administration | Experimental | Procedure: Pulse pressure variationIn 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. |
| Central venous pressure guidance fluid administration | Experimental | Procedure: Central venous pressureIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Arrhythmia
- Significant cardiac diseases
- Chronic obstructive airway disease
- Elevated intra-abdominal pressure
- Tumors prone to precipitate diabetes insipidus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse pressure variationAlso: PPVFluid administration during posterior fossa surgery in the parkbench position is guided by the PPV value. | Procedure or surgery | Pulse pressure variation guidance fluid administration |
| Central venous pressureAlso: CVPFluid administration during posterior fossa surgery in the parkbench position is guided by the CVP value. | Procedure or surgery | Central venous pressure guidance fluid administration |
Primary outcome
Total intraoperative fluid administration volumes during surgery
Time frame: during surgery
fluid and blood and blood volume transfusion during surgery
3 secondary outcomes
vital signs
Time frame: during surgery, the data will be recorded every 5 minutes throughout the procedure
vital signs
Time frame: during the admission in neurosurgical ICU up to 3 days after surgery
time to extubation
Time frame: 48 hours after surgery at the neurosurgical intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40455866Pin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pathomporn P Pin on, Associate Professor principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse pressure variation and Central venous pressure in people with Posterior Fossa Tumor and Brain Tumor Adult, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative fluid administration volumes during surgery (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.