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HypovolemiaRecruVolNCT03468764

Hemodynamic Changes Induced by Alveolar Recruitment Maneuver With Respect to Volemic State in Colon Surgery

An observational study of Hypovolemia, run by IRCCS San Raffaele at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Intraoperative hemodynamic management is important, since even mild variations in circulatory volume can be extremely damaging for patients. Minimally invasive hemodynamic monitoring are not always available or cost-effective, therefore management of fluids is challenging for anesthesiologists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypovolemia
What is being tested?
Vigileo monitoring during lung recruitment maneuver
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteItaly
Study dates
Mar 2018to Apr 2019
Phase
Observational
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

Study population: Patients undergoing scheduled laparoscopic colon surgery

Who may be able to join

  • Age >18 years
  • Elective surgery
  • ASA score 1-2-3
  • Informed consent

Who cannot join

  • Pregnancy
  • Relevant cardiac/pulmonary comorbidities
  • Cardiac/kidney failure
  • Haemodynamic shock

Trial locations and contacts

1 site in 1 country.

Marco Gemma, MD contact

+390226437863

gemma.marco@hsr.it

Marco Gemma, MD contact

+390226432656

gemma.marco@hsr.it

Italy1 site
  • S. Raffaele Hospital

    Milan, MI, 20132

Other trials in Italy

About this study

Official title: Evaluation of Hemodynamic Changes Induced by Alveolar Recruitment Maneuver With Respect to Volemic State in Patients Undergoing Anesthesia for Colon Surgery

Intraoperative hemodynamic management is important, since even mild variations in circulatory volume can be extremely damaging for patients.

Minimally invasive hemodynamic monitoring are not always available or cost-effective, therefore management of fluids is challenging for anesthesiologists.

Read more

This study aims to assess if, after performance of a lung recruitment maneuver (LRM), standard parameter's variation differs between hypovolemic and normovolemic patients.

Patients' volemic state will be assessed with the Vigileo system. Standard monitoring values (heart rate, invasive blood pressure and saturation) will be registered before and after LRMs.

A fluid challenge will be performed and the above mentioned parameters will be recorded again, after a second LRM.

The study is a prospective observational study.

Read the detailed description

During general anesthesia, it's important to maintain normovolemia, since hypovolemia can cause inadequate tissue perfusion and hypervolemia increases the rate of complications, overall mortality and morbidity.

Critically ill patients commonly present with important hypotension that, in the majority of cases, is promptly treated with intravenous fluids to reverse organ hypoperfusion.

However, previous studies have demonstrated that only 50% of hemodynamically unstable patients are responsive to fluid administration.

In the last decade, attention has been focused on finding a parameter capable of assessing fluid responsiveness in a hypotensive patient.

Recent articles have demonstrated that standard monitoring parameters have no significance for this purpose, while hemodynamic parameters, like stroke volume variation (SVV) or pulse pressure variation (PVV) may have an important role.

An interesting field of research involves heart-lung interactions during mechanical ventilation. In particular, lung recruitment maneuver (LRM) induce physiological cardiovascular alterations and may have a correlation with the volemic state of the patient.

LRMs are commonly performed and safe procedures that consist in application of a continuous positive pressure in the lungs of mechanically ventilated patient, with the aim of improving pulmonary compliance.

The goal of our study is to verify whether the alterations induced by lung recruitment maneuver on commonly registered intraoperative parameters, such as heart rate and arterial blood pressure, actually differ when the maneuver is applied to hypovolemic and normovolemic patients respectively.

Patients undergoing scheduled laparoscopic colon surgery will be enrolled. Informed consent will be obtained during the preoperative anesthesiological visit.

General anaesthesia will be managed according to standard clinical practice. Invasive blood pressure monitoring will be started with a peripheral arterial catheter and hemodynamic parameters (SVV and CO) will be monitored through the Vigileo device.

During the resection phase, the patient has to be maintained in hypovolemic conditions. When SVV reaches a value of 12-15%, a LRM is performed, consisting in the application of 30 cm H2O continuous positive airway pressure for 30 seconds.

Standard monitoring values (heart rate, invasive blood pressure and saturation) will be registered.

Thereafter, a fluid challenge will be performed, consisting in intravenous administration of 8 ml/kg of saline solution over 20 minutes. As soon as SVV will reach a value of 10%, LRM will be performed again and the abovementioned three sets of measurements will be carried out once again.

As standard management of LRM, the maneuver will be stopped if the heart rate would lower below 35 bpm or the systolic blood pressure would lower below 60 mmHg.

The information provided by the study is of interest in cases in which the deployment of sophisticated monitoring, as the Vigileo system, is not feasible or cost-effective. In this way, hemodynamic management during major surgeries would become faster and easier, relying on traditional monitoring.

Conditions
Hypovolemia
Being tested
Vigileo monitoring during lung recruitment maneuver
Keywords
anesthesia, hemodynamic management, lung recruitment maneuver, hypovolemia
Medical subject headings
Hypovolemia

What participants receive

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

  • Vigileo monitoring during lung recruitment maneuverProcedure or surgery

    Standard monitoring parameters, invasive blood pressure and hemodynamic values (SVV and CO, through Vigileo device) will be monitored. With the patient in a supine position and as SVV reaches a value of 12-15%, a LRM is performed, consisting in the application of 30 cm H2O continuous positive airway pressure for 30 seconds.

    The alterations in the above mentioned parameters will be registered before and after the maneuver.

    The same procedure will be performed after a 8 ml/kg crystalloids fluid challenge, as soon as SVV reaches the value of 10%.

What is being measured

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

  1. Hypovolemic indicator

    Finding an hypovolemic indicator among standard monitoring parameters

    Measured: Intraoperative

Timeline

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

  1. First posted19 Mar 2018
  2. Study startMar 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionApr 2019 (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 only
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468764
Sponsor's protocol ID
1/int/2018
Acronym
RecruVol
Status last verified
Mar 2018
First submitted
12 Mar 2018
Last updated
19 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypovolemia, run by IRCCS San Raffaele at 1 site in Italy.

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 4 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 Mar 2018. 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 Italy. 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?

Contact Marco Gemma, MD (+390226437863, gemma.marco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypovolemic indicator (time frame: Intraoperative). 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 19 Mar 2018.

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