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

Sponsor
University Hospital Dubrava (Other)
Overall Status
Unknown status
CT.gov ID
NCT04191408
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
3
Anticipated Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PEEP increase
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Predictive Ability of PEEP Induced CVP Changes to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Feb 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Stroke volume increase after passive leg raise [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Dubrava Zagreb Grad Zagreb Croatia 1000

    Sponsors and Collaborators

    • University Hospital Dubrava

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrej Šribar, MD, PhD, University Hospital Dubrava
    ClinicalTrials.gov Identifier:
    NCT04191408
    Other Study ID Numbers:
    • 20196996
    First Posted:
    Dec 9, 2019
    Last Update Posted:
    Dec 13, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Cardiac Output, Low
    Critical Illness

    Study Results

    No Results Posted as of Dec 13, 2019