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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

September 5, 2018

Estimated Primary Completion Date

June 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fluid responsivess assessment with the effective pulmonary blood flow[ Time Frame: 10 months ]

Comparison between standard method (pulse pressure variation) with a new method of fluid responsiveness (Effective pulmonary blood flow).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Reliability of Noninvasive Effective Pulmonary Blood Flow to Detect Fluid Responsiveness During a Positive End-expirator Trial in Ventilated Patients

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. We will study 40 patients undergoing mechanical ventilation during surgery. 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% and we will determine the corresponding cut off value for the effective pulmonary blood flow signal.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

: Patients undergoing surgeries
Patients undergoing surgery with general anesthesia and controlled mechanical ventilation with indication of invasive arterial blood pressure. Classification ASA 2-4

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 1, 2019

Estimated Primary Completion Date

June 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Argentina

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Hospital Privado de Comunidad de Mar del Plata

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Gerardo Tusman, MD Hospital Privado de Comunidad de Mar del Plata

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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