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

NCT03468764 | Unknown

• 1 other identifier: 1/int/2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovolemia

Keywords

anesthesia; hemodynamic management; lung recruitment maneuver; hypovolemia

Outcome Measures

Primary Outcomes (1)

• Hypovolemic indicator

  Finding an hypovolemic indicator among standard monitoring parameters

  Intraoperative

Interventions

Vigileo monitoring during lung recruitment maneuver PROCEDURE

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%.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing scheduled laparoscopic colon surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

S. Raffaele Hospital

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Gemma, MD

  IRCCS San Raffaele, Milan, Italy

  STUDY CHAIR

Central Study Contacts

Marco Gemma, MD

CONTACT

+390226437863; gemma.marco@hsr.it

Marco Gemma, MD

CONTACT

+390226432656; gemma.marco@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 19, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)