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Completed

NCT Number: NCT02569424

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient's position

Behavioral

Supine or Trendelenburg strict -20°)

Primary outcomes

  1. The cross-sectional area of the jugular veins ( in cm2)

    Time frame: at baseline

    The cross-sectional area of the jugular veins ( in cm2) at the end of the intervention

Secondary outcomes

  1. The cross-sectional area of the subclavian veins ( in cm2)

    Time frame: at baseline

    The cross-sectional area of the subclavian veins ( in cm2) at the end of the intervention

  2. The antero-posterior diameter of the jugular veins (in mm)

    Time frame: at baseline

    The antero-posterior diameter of the jugular veins (in mm) at the end of the intervention

  3. The antero-posterior diameter of the subclavian veins (in mm)

    Time frame: at baseline

    The antero-posterior diameter of the subclavian veins (in mm) at the end of the intervention

  4. The distance between posterior and pleural lining of the jugular veins (in mm)

    Time frame: at baseline

    The distance between posterior and pleural lining of the jugular veins (in mm) at the end of the intervention

  5. The distance between posterior and pleural lining of the subclavian veins (in mm)

    Time frame: at baseline

    The distance between posterior and pleural lining of the subclavian veins (in mm) at the end of the intervention

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: PEEPUS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 6, 2015
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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