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

Not Applicable

• Conditions: Surgery; Critical Illness; Cardiac Output, Low
• Interventions: Procedure: PEEP increase

• Registration Number: NCT04191408
• Lead Sponsor: University Hospital Dubrava

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.

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-09
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated patients after surgery	PEEP increase	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Grad Zagreb, Croatia