Influence of Two Different PEEP Niveaus and a Trendelenburg Positioning Manoeuvre on Subclavian Vein Diameter
1 other identifier
observational
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 26, 2016
January 1, 2016
1.5 years
June 4, 2014
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diameter of vein
measurement of vein Diameter by ultrasound in a randomized order
only 1 day (the day of the measurement); no follow-up is required
Study Arms (1)
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.
Interventions
Trendelenburg positioning -20°, PEEP 0 cmH2O
Trendelenburg positioning -20°, PEEP 5 cmH2O
Trendelenburg positioning -20°, PEEP 10 cmH2O
Eligibility Criteria
Patients undergoing a operative procedure which requires a central venous catheter
You may qualify if:
- Age \>18 years
- cardiosurgery or neurosurgery
- written informed consent
- ECG: inus rhythm
You may not qualify if:
- peacemaker
- kontraindications for PEEP
- pulmonary disease
- hemodynamically instable patients
- pregnancy
- pulmonal Hypertension
- ejection fraction \< 35%
- severe valvular disease
- tricuspid insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UK Köln
Cologne, North Rhine-Westphalia, 50937, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jochen Hinkelbein, MD
UK Köln
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med.
Study Record Dates
First Submitted
June 4, 2014
First Posted
September 4, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 26, 2016
Record last verified: 2016-01