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

Insufficiency; Cardiac, Complicating Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02231463
• Other study ID #: CVL-Position-1
• Status: Withdrawn
• Phase: N/A
• First received: June 4, 2014
• Last updated: January 25, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Universitätsklinikum Köln
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Insufficiency; Cardiac, Complicating Surgery

Intervention

Other:
• neutral positioning, PEEP 0 cm H2O
neutral positioning, PEEP 0 cm H2O
• neutral positioning, PEEP 5cm H2O
neutral positioning, PEEP 5cm H2O
• neutral positioning, PEEP 10cm H2O
neutral positioning, PEEP 10cm H2O
• Trendelenburg positioning -20°, PEEP 0 cmH2O
Trendelenburg positioning -20°, PEEP 0 cmH2O
• Trendelenburg positioning -20°, PEEP 5 cmH2O
Trendelenburg positioning -20°, PEEP 5 cmH2O
• Trendelenburg positioning -20°, PEEP 10 cmH2O
Trendelenburg positioning -20°, PEEP 10 cmH2O

Locations

Country	Name	City	State
Germany	UK Köln	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No