Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial

NCT ID: NCT03693365

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2022-04-12

Brief Summary

Fluid responsiveness is difficult to assess at the bedside. The accuracy of published techniques to detect preload-dependent patients have many pitfalls and limitations. The present study test the role of noninvasive effective pulmonary blood flow measured by expired carbon dioxide to detect fluid responsivess in mechanically ventilated patients.

Detailed Description

This is a prospective and observational study designed to test the accuracy of the non-invasive effective pulmonary blood flow measured by the capnodynamic methodology for detect preload-dependent patients.

Fourty patients undergoing mechanical ventilation during surgery will be studied. Preload-depency (fluid responsiveness) will be tested during an increase in end-expiratory pressure (PEEP) from 5 to 10 cmH2O during one minute. Pulse pressure variation will be use as the reference method to detect preload-dependency. The effective pulmonary blood flow will be continuously recorded during the PEEP maneuver. Receiver Operator Curves will be used to detect fluid responsiveness taking a pulse pressure variation higher than 13%.The corresponding cut off value for the effective pulmonary blood flow signal will be determined..

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing surgeries

Patients undergoing surgery with general anesthesia and controlled mechanical ventilation with indication of invasive arterial blood pressure.

Classification ASA 2-4

PEEP trial

Intervention Type: PROCEDURE

Positive end-expiratory pressure (PEEP) is increased from 5 to 10 cmH2O during one minute.

Interventions

PEEP trial

Positive end-expiratory pressure (PEEP) is increased from 5 to 10 cmH2O during one minute.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Programmed cardiac and noncardiac surgeries
• Need of invasive arterial blood pressure monitoring.

Exclusion Criteria

• Emergency surgeries.
• Acute pulmonary diseases
• Arrhytmias
• Congestive cardiac failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerardo Tusman, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado de Comunidad de Mar del Plata

Locations

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, Argentina

Countries

Argentina

References

Tusman G, Groisman I, Maidana GA, Scandurra A, Arca JM, Bohm SH, Suarez-Sipmann F. The Sensitivity and Specificity of Pulmonary Carbon Dioxide Elimination for Noninvasive Assessment of Fluid Responsiveness. Anesth Analg. 2016 May;122(5):1404-11. doi: 10.1213/ANE.0000000000001047.

Reference Type: RESULT

PMID: 26505574 (View on PubMed)

Other Identifiers

291917072018

Identifier Type: -

Identifier Source: org_study_id