Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693365
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Hospital Privado de Comunidad de Mar del Plata

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Procedure: PEEP trial

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..

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Reliability of Noninvasive Effective Pulmonary Blood Flow to Detect Fluid Responsiveness During a Positive End-expirator Trial in Ventilated Patients
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Clinical Trials

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patients undergoing surgeries

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

Classification ASA 2-4

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac and noncardiac surgery patients ASA 2-4
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693365


Contacts
Layout table for location contacts
Contact: Cecilia M Acosta, MD 542234990074 ceciliamacosta@hotmail.com
Contact: Esteban Gándara, MD 542234990099 gandara.esteban@gmail.com

Locations
Layout table for location information
Argentina
Hospital Privado de Comunidad Recruiting
Mar del Plata, Buenos Aires, Argentina, 7600
Sponsors and Collaborators
Hospital Privado de Comunidad de Mar del Plata
Investigators
Layout table for investigator information
Principal Investigator: Gerardo Tusman, MD Hospital Privado de Comunidad de Mar del Plata
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Hospital Privado de Comunidad de Mar del Plata
ClinicalTrials.gov Identifier: NCT03693365    
Other Study ID Numbers: 291917072018
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Privado de Comunidad de Mar del Plata:
Carbon dioxide
Pulmonary blood flow
Ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases