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

Primary Purpose

Surgery, Critical Illness, Cardiac Output, Low

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
PEEP increase
Sponsored by
University Hospital Dubrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital DubravaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mechanically ventilated patients after surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Stroke volume increase after passive leg raise
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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2019
Last Updated
December 11, 2019
Sponsor
University Hospital Dubrava
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1. Study Identification

Unique Protocol Identification Number
NCT04191408
Brief Title
Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery
Official Title
Predictive Ability of PEEP Induced CVP Changes to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Critical Illness, Cardiac Output, Low

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mechanically ventilated patients after surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PEEP increase
Other Intervention Name(s)
Passive leg raise
Intervention Description
PEEP increase +5 to +15 cmH2O. PLR at 30 degrees.
Primary Outcome Measure Information:
Title
Stroke volume increase after passive leg raise
Description
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.
Time Frame
Within 30 seconds after PLR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrej Šribar, MD, PhD
Phone
+385959404034
Email
andrej.sribar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Šribar, MD, PhD
Organizational Affiliation
Anesthesiologist and Intensive care medicine specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
1000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Šribar, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Might share anonymized measured data.
Citations:
PubMed Identifier
21622963
Citation
Geerts BF, Aarts LP, Groeneveld AB, Jansen JR. Predicting cardiac output responses to passive leg raising by a PEEP-induced increase in central venous pressure, in cardiac surgery patients. Br J Anaesth. 2011 Aug;107(2):150-6. doi: 10.1093/bja/aer125. Epub 2011 May 27.
Results Reference
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Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery

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