- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693365
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
The Reliability of Noninvasive Effective Pulmonary Blood Flow to Detect Fluid Responsiveness During a Positive End-expirator Trial in Ventilated Patients
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Buenos Aires
-
Mar del Plata, Buenos Aires, Argentina, 7600
- Hospital Privado De Comunidad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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 |
Positive end-expiratory pressure (PEEP) is increased from 5 to 10 cmH2O during one minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
10 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gerardo Tusman, MD, Hospital Privado de Comunidad de Mar del Plata
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291917072018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinActive, not recruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on PEEP trial
-
University Hospital, AngersUnknownCOVID | Acute Respiratory Distress SyndromeFrance
-
Università degli Studi di FerraraRecruitingObesity | Mechanical Ventilation Pressure High | Intraoperative Respiratory InjuryItaly
-
Policlinico HospitalCompletedRespiratory FailureItaly
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...RecruitingARDS | Respiratory Disease | Pediatric Respiratory Distress SyndromeItaly
-
Gachon University Gil Medical CenterCompletedThe Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy (lapaPEEP)Brain IschemiaKorea, Republic of
-
Mansoura UniversityRecruitingOne Lung VentilationEgypt
-
Hongpeng LiCompletedTraumatic Brain Injury | Mechanical Ventilation Complication
-
University Hospital, AngersNot yet recruiting
-
University of TriesteCompletedThoracic Surgery | One-lung Ventilation | Respiratory Mechanics | Artificial RespirationItaly