Influence of Two Different PEEP Niveaus and a Trendelenbu... | NCT02231463

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

NCT02231463

Sponsor

Universitätsklinikum Köln

Status

Withdrawn

Last Update Posted

Jan 26, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Insufficiency; Cardiac, Complicating Surgery

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 4, 2014

First Submission Date that Met QC Criteria

Sep 3, 2014

First Posted Date

Sep 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neutral positioning, PEEP 0 cm H2O	Other	neutral positioning, PEEP 0 cm H2O	ultrasound measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing a operative procedure which requires a central venous catheter

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Hinkelbein, MD	UK Köln	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UK Köln		Cologne	North Rhine-Westphalia	50937	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy