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

Withdrawn

• Conditions: Insufficiency; Cardiac, Complicating Surgery
• Interventions: Other: neutral positioning, PEEP 0 cm H2O; Other: neutral positioning, PEEP 5cm H2O; Other: neutral positioning, PEEP 10cm H2O; Other: Trendelenburg positioning -20°, PEEP 0 cmH2O; Other: Trendelenburg positioning -20°, PEEP 5 cmH2O; Other: Trendelenburg positioning -20°, PEEP 10 cmH2O

• Registration Number: NCT02231463
• Lead Sponsor: Universitätsklinikum Köln

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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultrasound measurement	neutral positioning, PEEP 0 cm H2O	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.
ultrasound measurement	neutral positioning, PEEP 5cm H2O	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.
ultrasound measurement	Trendelenburg positioning -20°, PEEP 0 cmH2O	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.
ultrasound measurement	Trendelenburg positioning -20°, PEEP 10 cmH2O	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.
ultrasound measurement	neutral positioning, PEEP 10cm H2O	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.
ultrasound measurement	Trendelenburg positioning -20°, PEEP 5 cmH2O	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.

Primary Outcome Measures

Name	Time	Method
Diameter of vein	only 1 day (the day of the measurement); no follow-up is required	measurement of vein Diameter by ultrasound in a randomized order

Trial Locations

Locations (1)

UK Köln; 🇩🇪 Cologne, NRW, Germany