Insufficiency; Cardiac, Complicating SurgeryNCT02231463
Influence of Two Different PEEP Niveaus and a Trendelenburg Positioning Manoeuvre on Subclavian Vein Diameter
An observational study of Insufficiency; Cardiac, Complicating Surgery, run by Universitätsklinikum Köln at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insufficiency; Cardiac, Complicating Surgery
- What is being tested?
- neutral positioning, PEEP 0 cm H2O, neutral positioning, PEEP 5cm H2O and neutral positioning, PEEP 10cm H2O
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Dec 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a operative procedure which requires a central venous catheter
Who may be able to join
- Age >18 years
- cardiosurgery or neurosurgery
- written informed consent
- ECG: inus rhythm
Who cannot join
- peacemaker
- kontraindications for PEEP
- pulmonary disease
- hemodynamically instable patients
- pregnancy
- pulmonal Hypertension
Show all 9Show fewer
- ejection fraction < 35%
- severe valvular disease
- tricuspid insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- 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
- Keywords
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neutral positioning, PEEP 0 cm H2OOther
neutral positioning, PEEP 0 cm H2O
neutral positioning, PEEP 5cm H2OOther
neutral positioning, PEEP 5cm H2O
neutral positioning, PEEP 10cm H2OOther
neutral positioning, PEEP 10cm H2O
Trendelenburg positioning -20°, PEEP 0 cmH2OOther
Trendelenburg positioning -20°, PEEP 0 cmH2O
Trendelenburg positioning -20°, PEEP 5 cmH2OOther
Trendelenburg positioning -20°, PEEP 5 cmH2O
Trendelenburg positioning -20°, PEEP 10 cmH2OOther
Trendelenburg positioning -20°, PEEP 10 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of vein
measurement of vein Diameter by ultrasound in a randomized order
Measured: only 1 day (the day of the measurement); no follow-up is required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficiency; Cardiac, Complicating SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Hinkelbein, Universitätsklinikum Köln
- Investigators
- Jochen Hinkelbein, MD, Principal investigator, UK Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231463
- Sponsor's protocol ID
- CVL-Position-1
- Status last verified
- Jan 2016
- First submitted
- 4 Jun 2014
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02231463
- Acronym / sponsor ID
- CVL-Position-1
- Keywords
- ultrasound
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound measurement | – | 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 cmH2Omeasuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a operative procedure which requires a central venous catheter
Key inclusion criteria (4 listed)
- Age >18 years
- cardiosurgery or neurosurgery
- written informed consent
- ECG: inus rhythm
Key exclusion criteria (9 listed)
- peacemaker
- kontraindications for PEEP
- pulmonary disease
- hemodynamically instable patients
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neutral positioning, PEEP 0 cm H2Oneutral positioning, PEEP 0 cm H2O | Other | ultrasound measurement |
| neutral positioning, PEEP 5cm H2Oneutral positioning, PEEP 5cm H2O | Other | ultrasound measurement |
| neutral positioning, PEEP 10cm H2Oneutral positioning, PEEP 10cm H2O | Other | ultrasound measurement |
| Trendelenburg positioning -20°, PEEP 0 cmH2OTrendelenburg positioning -20°, PEEP 0 cmH2O | Other | ultrasound measurement |
| Trendelenburg positioning -20°, PEEP 5 cmH2OTrendelenburg positioning -20°, PEEP 5 cmH2O | Other | ultrasound measurement |
| Trendelenburg positioning -20°, PEEP 10 cmH2OTrendelenburg positioning -20°, PEEP 10 cmH2O | Other | ultrasound measurement |
Primary outcome
Diameter of vein
Time frame: only 1 day (the day of the measurement); no follow-up is required
measurement of vein Diameter by ultrasound in a randomized order
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Hinkelbein, MD principal investigator
UK Köln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insufficiency; Cardiac, Complicating Surgery, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of vein (time frame: only 1 day (the day of the measurement); no follow-up is required). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.