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

NCT ID: NCT02569424

Last Updated: 2016-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ventilated patients

Patient's position (Supine or Trendelenburg strict -20°)

Group Type: EXPERIMENTAL

Patient's position

Intervention Type: BEHAVIORAL

Supine or Trendelenburg strict -20°)

Interventions

Patient's position

Supine or Trendelenburg strict -20°)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien PERBET

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2015-A00606-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHU-0246

Identifier Type: -

Identifier Source: org_study_id