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.
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.
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.
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.
- First posted19 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Gemma, IRCCS San Raffaele
- Investigators
- Marco Gemma, MD, Study chair, IRCCS San Raffaele, Milan, Italy
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Changes Induced by Alveolar Recruitment Maneuver With Respect to Volemic State in Patients Undergoing Anesthesia for Colon Surgery
- ClinicalTrials.gov ID
- NCT03468764
- Acronym / sponsor ID
- RecruVol / 1/int/2018
- Conditions
- Hypovolemia
- Keywords
- anesthesia, hemodynamic management, lung recruitment maneuver, hypovolemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 19 Mar 2018 (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.
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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled laparoscopic colon surgery
Key inclusion criteria (4 listed)
- Age >18 years
- Elective surgery
- ASA score 1-2-3
- Informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Relevant cardiac/pulmonary comorbidities
- Cardiac/kidney failure
- Haemodynamic shock
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 |
|---|---|---|
| Vigileo monitoring during lung recruitment maneuverStandard 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%. | Procedure or surgery | – |
Primary outcome
Hypovolemic indicator
Time frame: Intraoperative
Finding an hypovolemic indicator among standard monitoring parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Marco Gemma, MD study chair
IRCCS San Raffaele, Milan, Italy
1 site in 1 country: see every site and its status.
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.