Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position Clinical Trial
— PEEPUSOfficial title:
Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |