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

• Sponsor: Universitätsklinikum Köln (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02231463
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insufficiency; Cardiac, Complicating Surgery	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

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 0 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UK Köln	Cologne	NRW	Germany	50937

Sponsors and Collaborators

• Universitätsklinikum Köln

Investigators

• Principal Investigator: Jochen Hinkelbein, MD, UK Köln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jochen Hinkelbein, PD Dr. med., Universitätsklinikum Köln
• ClinicalTrials.gov Identifier: NCT02231463
• Other Study ID Numbers: CVL-Position-1
• First Posted: Sep 4, 2014
• Last Update Posted: Jan 26, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Jochen Hinkelbein, PD Dr. med., Universitätsklinikum Köln: ultrasound
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 26, 2016