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

NCT ID: NCT04191408

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-02-01

Brief Summary

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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

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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

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Surgery Critical Illness Cardiac Output, Low

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PEEP increase

Intervention Type PROCEDURE

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

Interventions

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PEEP increase

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

Intervention Type PROCEDURE

Other Intervention Names

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Passive leg raise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Andrej Šribar

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrej Šribar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiologist and Intensive care medicine specialist

Locations

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University Hospital Dubrava

Zagreb, City of Zagreb, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Andrej Šribar, MD, PhD

Role: CONTACT

Phone: +385959404034

Email: [email protected]

Facility Contacts

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Andrej Šribar, MD, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 21622963 (View on PubMed)

Other Identifiers

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20196996

Identifier Type: -

Identifier Source: org_study_id