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

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.

Study Overview

• Status: Completed
• Conditions: Ventilated Patient in Intensive Care; Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position
• Intervention / Treatment: Behavioral: Patient's position

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: central venous catheter; Trendelenburg position; PEEP level; cross-sectional area of the jugular and subclavian veins
• Other Study ID Numbers: CHU-0246; 2015-A00606-43 (Registry Identifier: 2015-A00606-43)