Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins

Study Overview
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Brief Summary
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There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins. In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner. The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

Detailed Description
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There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins. In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner. The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

Official Title
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Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study

Conditions
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Ventilated Patient in Intensive Care, Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position

Intervention / Treatment
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* Behavioral: Patient's position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient ventilated in intensive care is eligible. Age ≥ 18 years Patient with stable hemodynamic status and Mean Blood Pressure (< 65 mmHg) Patient with registered social security number Exclusion Criteria: clinical sign for a central venous thrombosis (unilateral edema ...).during echography screening before inclusion presence of a central line for more than 48 hours. Anechoic patient (checked during echography screening) History of cervical spine surgery. IntraCranial HyperTension patient in shock with hemodynamic instability and not stabilized patient treated by noradrenaline > 1 µg/kg/min patient or relative's refusal protected patients ≥ 18 years, minors, pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ventilated patients<br>Patient's position (Supine or Trendelenburg strict -20°) | Behavioral: Patient's position<br>* Supine or Trendelenburg strict -20°)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cross-sectional area of the jugular veins ( in cm2) | The cross-sectional area of the jugular veins ( in cm2) at the end of the intervention | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cross-sectional area of the subclavian veins ( in cm2) | The cross-sectional area of the subclavian veins ( in cm2) at the end of the intervention | at baseline | 
| The antero-posterior diameter of the jugular veins (in mm) | The antero-posterior diameter of the jugular veins (in mm) at the end of the intervention | at baseline | 
| The antero-posterior diameter of the subclavian veins (in mm) | The antero-posterior diameter of the subclavian veins (in mm) at the end of the intervention | at baseline | 
| The distance between posterior and pleural lining of the jugular veins (in mm) | The distance between posterior and pleural lining of the jugular veins (in mm) at the end of the intervention | at baseline | 
| The distance between posterior and pleural lining of the subclavian veins (in mm) | The distance between posterior and pleural lining of the subclavian veins (in mm) at the end of the intervention | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEEP level, Trendelenburg position, cross-sectional area of the jugular and subclavian veins, central venous catheter