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

NCT04191408 | Unknown

• 1 other identifier: 20196996
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Critical Illness; Cardiac Output, Low

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Mechanically ventilated patients after surgery

EXPERIMENTAL

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

Interventions

PEEP increase PROCEDURE

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

Also known as: Passive leg raise

Mechanically ventilated patients after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, City of Zagreb, 1000, Croatia

RECRUITING

Related 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. Epub 2011 May 27.

  PMID: 21622963 RESULT

MeSH Terms

Conditions

Critical Illness; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms

Study Officials

• Andrej Šribar, MD, PhD

  Anesthesiologist and Intensive care medicine specialist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrej Šribar, MD, PhD

CONTACT

+385959404034; andrej.sribar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 9, 2019
• Study Start: November 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

CR (1)