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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191408
• Other study ID #: 20196996
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: December 2019
• Source: University Hospital Dubrava
• Contact: Andrej Šribar, MD, PhD
• Phone: +385959404034
• Email: andrej.sribar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output, Low
• Critical Illness
• Surgery

Intervention

Procedure:
• PEEP increase
PEEP increase +5 to +15 cmH2O. PLR at 30 degrees.

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb	Grad Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 30 seconds after PLR