Clinical trial NCT02569424: Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins
Official title: Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilated Patient in Intensive Care
Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position
Keywords: PEEP level
Trendelenburg position
cross-sectional area of the jugular and subclavian veins
central venous catheter
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The cross-sectional area of the jugular veins ( in cm2)
timeFrame: at baseline
Secondary outcomes:
measure: The cross-sectional area of the subclavian veins ( in cm2)
timeFrame: at baseline
measure: The antero-posterior diameter of the jugular veins (in mm)
timeFrame: at baseline
measure: The antero-posterior diameter of the subclavian veins (in mm)
timeFrame: at baseline
measure: The distance between posterior and pleural lining of the jugular veins (in mm)
timeFrame: at baseline
measure: The distance between posterior and pleural lining of the subclavian veins (in mm)
timeFrame: at baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References: