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Fluid ResponsivenessFLUID-LAPNCT07911059

Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge

An observational study of Fluid Responsiveness and Laparoscopic Surgery, run by University Of Perugia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background Fluid management is central to perioperative care, but only about half of surgical patients increase their stroke volume after a fluid challenge. Dynamic indices such as pulse pressure variation and stroke volume variation are often unreliable during laparoscopy, because of low tidal volume ventilation and… Read more about this study

Who is it for?
Ages 18 years and older
How many people
104 participants
Where
No sites listed yet
Study dates
1 Jan 2027to Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Adults undergoing elective major laparoscopic or robot-assisted abdominal, urological or gynecological-oncological surgery under CO2 pneumoperitoneum, mechanically ventilated, with invasive arterial pressure and uncalibrated pulse-contour cardiac output monitoring, recruited at four centres.

Who may be able to join

  • Age 18 years or older
  • Scheduled for elective major laparoscopic or robot-assisted surgery (abdominal, urological or gynecological-oncological) under CO2 pneumoperitoneum, with expected duration longer than 60 minutes
  • Controlled mechanical ventilation (volume-controlled, tidal volume 7 ml/kg predicted body weight)
  • Invasive arterial pressure monitoring and continuous uncalibrated pulse-contour cardiac output monitoring in place as standard of care
  • Written informed consent obtained before surgery

Who cannot join

  • Any recurrent cardiac arrhythmia
  • Known reduced left ventricular (ejection fraction below 30%) or right ventricular (tricuspid annular systolic peak velocity below 0.17 m/s) systolic function
  • Severe valvular heart disease
  • Body mass index above 35 kg/m2
  • Chronic obstructive pulmonary disease, GOLD stage 2 or higher
  • Residual spontaneous ventilatory activity or ventilator triggering
Show all 9Show fewer
  • Pregnancy
  • Concurrent participation in an interventional study
  • Intraoperative exclusion (patient withdrawn after enrollment): significant bleeding (more than 500 ml in 30 minutes); persistent or recurrent extrasystoles during the protocol; persistent poor quality of the arterial pressure signal despite optimization;

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: FLUID Responsiveness in LAParoscopic Surgery: A Prospective, Multicentre, Observational Diagnostic-accuracy Cohort Study Comparing the End-expiratory Occlusion Test and the Mini-fluid Challenge for the Prediction of Fluid Responsiveness During Laparoscopic Surgery

Background Fluid management is central to perioperative care, but only about half of surgical patients increase their stroke volume after a fluid challenge. Dynamic indices such as pulse pressure variation and stroke volume variation are often unreliable during laparoscopy, because of low tidal volume ventilation and carbon dioxide (CO2) pneumoperitoneum. Functional hemodynamic tests may overcome these limitations. In the Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiveness in the opeRating room (MANEUVER) study (NCT03808753), conducted in open abdominal surgery, the mini-fluid challenge predicted fluid responsiveness well, whereas the end-expiratory occlusion test did not. Pneumoperitoneum raises intra-abdominal pressure instead of abolishing it, so these results cannot be extrapolated to laparoscopy.

Design FLUID-LAP is a prospective, multicenter, observational diagnostic-accuracy cohort study conducted in four Italian centers and reported according to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 statement. Each patient is their own control: both index tests and the reference standard are performed in sequence in the same patient during a period of stable intraoperative hemodynamics, so the resulting receiver operating characteristic (ROC) curves are correlated. The study replicates the design of MANEUVER, changing only the surgical setting. Ventilation (volume-controlled, 7 ml/kg predicted body weight), the reference fluid challenge and uncalibrated pulse-contour monitoring are the same, to allow direct comparison with the open-abdomen data.

Read more

Procedures Tests are performed under standardized baseline conditions (stable pneumoperitoneum and position, unchanged ventilation, no recent drug changes or surgical manipulation, arterial waveform checked with a square-wave test). The order of the two index tests is chosen by the attending anesthesiologist, is recorded for every patient, and is analyzed as a pre-specified covariate. A 3-minute return to steady state separates the tests. The complete 4 ml/kg fluid challenge is given after both tests. The maneuvers are already part of routine goal-directed practice, and no treatment decision is dictated by the protocol. Patient safety always prevails over the protocol.

Analysis The primary analysis compares the areas under the ROC curves (AUC) of the two tests using the DeLong test. The expected AUCs are 0.90 for the mini-fluid challenge and 0.75 for the end-expiratory occlusion test. With 80% power and a two-sided alpha of 0.05, 87 evaluable patients are required; 104 will be enrolled to allow for 15% attrition (26 per center). Pre-specified analyses address the mathematical coupling between the mini-fluid challenge and the reference challenge, the effect of test order, and subgroups by intra-abdominal pressure and patient position.

Read the detailed description

Background Fluid management is central to perioperative care, but only about half of surgical patients increase their stroke volume after a fluid challenge. Dynamic indices such as pulse pressure variation and stroke volume variation are often unreliable during laparoscopy, because of low tidal volume ventilation and carbon dioxide (CO2) pneumoperitoneum. Functional hemodynamic tests may overcome these limitations. In the Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiveness in the opeRating room (MANEUVER) study (NCT03808753), conducted in open abdominal surgery, the mini-fluid challenge predicted fluid responsiveness well, whereas the end-expiratory occlusion test did not. Pneumoperitoneum raises intra-abdominal pressure instead of abolishing it, so these results cannot be extrapolated to laparoscopy.

Design FLUID-LAP is a prospective, multicenter, observational diagnostic-accuracy cohort study conducted in Italian centers and reported according to the Standards for Reporting of Diagnostic Accuracy (STARD) 2015 statement. Each patient is their own control: both index tests and the reference standard are performed in sequence in the same patient during a period of stable intraoperative hemodynamics, so the resulting receiver operating characteristic (ROC) curves are correlated. The study replicates the design of MANEUVER, changing only the surgical setting. Ventilation (volume-controlled, 7 ml/kg predicted body weight), the reference fluid challenge and uncalibrated pulse-contour monitoring are the same, to allow direct comparison with the open-abdomen data.

Procedures Tests are performed under standardized baseline conditions (stable pneumoperitoneum and position, unchanged ventilation, no recent drug changes or surgical manipulation, arterial waveform checked with a square-wave test). The order of the two index tests is chosen by the attending anesthesiologist, is recorded for every patient, and is analyzed as a pre-specified covariate. A 3-minute return to steady state separates the tests. The complete 4 ml/kg fluid challenge is given after both tests. The maneuvers are already part of routine goal-directed practice, and no treatment decision is dictated by the protocol. Patient safety always prevails over the protocol.

Analysis The primary analysis compares the areas under the ROC curves (AUC) of the two tests using the DeLong test. The expected AUCs are 0.90 for the mini-fluid challenge and 0.75 for the end-expiratory occlusion test. With 80% power and a two-sided alpha of 0.05, 87 evaluable patients are required; 104 will be enrolled to allow for 15% attrition. Pre-specified analyses address the mathematical coupling between the mini-fluid challenge and the reference challenge, the effect of test order, and subgroups by intra-abdominal pressure and patient position.

Keywords
stroke volume index, end-expiratory occlusion test, mini-fluid challenge, functional hemodynamic tests, pneumoperitoneum, goal-directed fluid therapy, diagnostic accuracy, robot-assisted surgery
Medical subject headings
Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07911059
Study groupRoleWhat they receive
Adults undergoing major laparoscopic or robot-assisted surgeryAdults (18 years or older) scheduled for elective major laparoscopic or robot-assisted surgery under CO2 pneumoperitoneum, mechanically ventilated, with invasive arterial pressure and uncalibrated pulse-contour cardiac output monitoring. Each participant undergoes both index tests in sequence during a period of stable intraoperative hemodynamics: the end-expiratory occlusion test (30-second end-expiratory hold) and the mini-fluid challenge (100 ml of lactated Ringer's over 1 minute). The order of the two tests is chosen by the attending anesthesiologist and recorded. The reference standard is a fluid challenge of 4 ml/kg predicted body weight of lactated Ringer's over about 10 minutes; fluid responsiveness is defined as an increase in stroke volume index of 10% or more. The tests are already used in routine goal-directed practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in area under the ROC curve (AUC) between the mini-fluid challenge and the end-expiratory occlusion test for predicting fluid responsiveness

    Percent change in stroke volume index (ΔSVI%) after the mini-fluid challenge (100 ml lactated Ringer's over 1 minute) and after the end-expiratory occlusion test (30-second expiratory hold) is used as a continuous predictor. Fluid responsiveness is defined as an increase in stroke volume index of 10% or more after a fluid challenge of 4 ml/kg predicted body weight of lactated Ringer's over about 10 minutes. The AUCs of the two tests are compared as correlated ROC curves using the DeLong test. Stroke volume index is measured by uncalibrated pulse-contour analysis.

    Measured: Perioperative/Periprocedural

Secondary outcomes (4)
  1. Area under the ROC curve (AUC) of each test for predicting fluid responsiveness

    AUC with 95% confidence interval (DeLong) of the percent change in stroke volume index after the end-expiratory occlusion test (30 seconds) and after the mini-fluid challenge, and of baseline pulse pressure variation (PPV) and stroke volume variation (SVV), for predicting fluid responsiveness (increase in stroke volume index of 10% or more after a 4 ml/kg fluid challenge).

    Measured: Perioperative/Periprocedural

  2. Optimal cut-off, sensitivity, specificity, predictive values and likelihood ratios of each test

    For the end-expiratory occlusion test and the mini-fluid challenge: best cut-off of the percent change in stroke volume index by the Youden index, with sensitivity, specificity, positive and negative predictive values and positive and negative likelihood ratios, each with 95% confidence interval (Wilson method).

    Measured: Perioperative/Periprocedural

  3. Prevalence of fluid responsiveness in the study population

    Proportion of participants with an increase in stroke volume index of 10% or more after the 4 ml/kg fluid challenge of lactated Ringer's over about 10 minutes.

    Measured: Perioperative/Periprocedural

  4. Grey zone of each test and comparison of grey-zone widths

    Grey zone of the end-expiratory occlusion test and of the mini-fluid challenge, defined by a lower cut-off including 90% of non-responders and an upper cut-off predicting fluid responsiveness in 90% of cases. The intermediate range is considered inconclusive. The widths of the two grey zones are compared.

    Measured: Perioperative/Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07911059
Sponsor's protocol ID
FLUID-LAP
Acronym
FLUID-LAP
Status last verified
Oct 2026
First submitted
25 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned to be shared, as participants consented only to the use of aggregated, anonymous data. Any future sharing would require ethics committee approval and, if needed, a new participant consent.

Questions about this trial

What is this clinical trial studying?

An observational study of Fluid Responsiveness and Laparoscopic Surgery, run by University Of Perugia.

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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachele Simonte (3203732319, rachele.simonte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in area under the ROC curve (AUC) between the mini-fluid challenge and the end-expiratory occlusion test for predicting fluid responsiveness (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Nov 2026.

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