Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

December 11, 2019 updated by: Andrej Šribar, University Hospital Dubrava

Predictive Ability of PEEP Induced CVP Changes to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Interventional study which will assess whether an positive end expiratory pressure induced increase of central venous pressure is a valid predictor of volume responsiveness in mechanically ventilated patients after major abdominal surgery assessed by increase of cardiac output after passive leg raise.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 1000
        • Recruiting
        • University Hospital Dubrava
        • Contact:
          • Andrej Šribar, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mechanically ventilated and sedated patients admitted to the ICU after major abdominal surgery

Exclusion Criteria:

  • Heart failure NYHA III or more
  • Severe obstructive or restrictive lung disease
  • Hypotension with MAP < 60 mmHg
  • Tachycardia > 140 beats / min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanically ventilated patients after surgery
After ICU admission the patient's hemodynamics (MAP, HR, CO, PPV) will be measured in supine position. It will be remeasured after PEEP has been increased from +5 to +15 cmH20. Then the baseline measurement will be repeated. Then passive leg raise will be performed and all the parameters will be remeasured.
Procedure: PEEP increase
PEEP increase +5 to +15 cmH2O. PLR at 30 degrees.
Other Names:
  • Passive leg raise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke volume increase after passive leg raise
Time Frame: Within 30 seconds after PLR

Patients who have a stroke volume (measured in ml) increase of 7% or more after passive leg raise will be considered volume responsive.

After the patients have been stratified into volume responders and volume non-responders, sensitivity and specificity of PEEP induced increase in CVP and pulse pressure variation will be assessed and further statistical analysis will be performed.
Within 30 seconds after PLR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Investigators

  • Principal Investigator: Andrej Šribar, MD, PhD, Anesthesiologist and Intensive care medicine specialist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20196996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Might share anonymized measured data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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