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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03468764
Acronym
RecruVol
Enrollment
30
Registered
2018-03-19
Start date
2018-03-31
Completion date
2019-04-30
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia

Keywords

anesthesia, hemodynamic management, lung recruitment maneuver, hypovolemia

Brief 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. 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.

Interventions

PROCEDUREVigileo monitoring during lung recruitment maneuver

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%.

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Hypovolemic indicatorIntraoperativeFinding an hypovolemic indicator among standard monitoring parameters

Countries

Italy

Contacts

Primary ContactMarco Gemma, MD
gemma.marco@hsr.it+390226437863
Backup ContactMarco Gemma, MD
gemma.marco@hsr.it+390226432656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026