Influence of Two Different PEEP Niveaus and a Trendelenburg Positioning Manoeuvre on Subclavian Vein Diameter

January 25, 2016 updated by: Jochen Hinkelbein, Universitätsklinikum Köln

Influence of Two Different PEEP Niveaus and a Trendelenburg Positioning Manoeuvre on Subclavian Vein Diameter as a Surrogate Parameter in Punctures of Central Veins

In 50 Patients who are undergoing a planned surgical procedure which require a central venous catheter the diameter of the subclavian vein is measured by ultrasound under 6 different conditions.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

In 50 Patients who are undergoing a planned surgical procedure which require a central venous catheter the diameter of the subclavian vein is measured by ultrasound under 6 different conditions. The conditions are

  1. neutral positioning, PEEP 0 cm H2O,
  2. neutral positioning, PEEP 5cm H2O,
  3. neutral positioning, PEEP 10cm H2O,
  4. Trendelenburg positioning -20°, PEEP 0 cmH2O,
  5. Trendelenburg positioning -20°, PEEP 5 cmH2O,
  6. Trendelenburg positioning -20°, PEEP 10 cmH2O After these measurements a central venous catheter is used to measure the central venous pressure.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • UK Köln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing a operative procedure which requires a central venous catheter

Description

Inclusion Criteria:

  • Age >18 years
  • cardiosurgery or neurosurgery
  • written informed consent
  • ECG: inus rhythm

Exclusion Criteria:

  • peacemaker
  • kontraindications for PEEP
  • pulmonary disease
  • hemodynamically instable patients
  • pregnancy
  • pulmonal Hypertension
  • ejection fraction < 35%
  • severe valvular disease
  • tricuspid insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ultrasound measurement

measuring subclavian vein Diameter in six Groups:

neutral positioning, PEEP 0 cm H2O, neutral positioning, PEEP 5cm H2O, neutral positioning, PEEP 10cm H2O, Trendelenburg positioning -20°, PEEP 0 cmH2O, Trendelenburg positioning -20°, PEEP 5 cmH2O, Trendelenburg positioning -20°, PEEP 10 cmH2O After these measurements a central venous catheter is used to measure the central venous pressure.
Other: neutral positioning, PEEP 0 cm H2O
neutral positioning, PEEP 0 cm H2O
Other: neutral positioning, PEEP 5cm H2O
neutral positioning, PEEP 5cm H2O
Other: neutral positioning, PEEP 10cm H2O
neutral positioning, PEEP 10cm H2O
Other: Trendelenburg positioning -20°, PEEP 0 cmH2O
Trendelenburg positioning -20°, PEEP 0 cmH2O
Other: Trendelenburg positioning -20°, PEEP 5 cmH2O
Trendelenburg positioning -20°, PEEP 5 cmH2O
Other: Trendelenburg positioning -20°, PEEP 10 cmH2O
Trendelenburg positioning -20°, PEEP 10 cmH2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diameter of vein
Time Frame: only 1 day (the day of the measurement); no follow-up is required
measurement of vein Diameter by ultrasound in a randomized order
only 1 day (the day of the measurement); no follow-up is required

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Köln

Investigators

  • Principal Investigator: Jochen Hinkelbein, MD, UK Köln

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVL-Position-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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