General AnaesthesiaNCT02166580
Accuracy of CNAP PPV Under General Anaesthesia
An observational study of General Anaesthesia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor. Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- General Anaesthesia
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jul 2015
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major surgery with the need for invasive arterial pressure monitoring
Who may be able to join
- major surgery
- need for invasive arterial measurements
Who cannot join
- age under 18
- cardiac dysrhythmia
- vascular pathology at punction site
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital, Schleswig-Holstein. Departement of Anaesthesiology and Intensive Care Medicine
Kiel, 24106
About this study
Official title: Comparison of the Non-invasive CNAP Pulse Pressure Variation With the Invasive Gold Standard
Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor.
Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.
Read the detailed description
Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually calculated PPV from the arterial line waveform. Established tests like passive leg raising and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative events like volume challenge are monitored.
- Conditions
- General Anaesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Improvement of cardiac output dependent on PPV before volume challenge
Measured: 1, 2, 5, 10, 15 and 20 minutes after volume challange and
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnaesthesiaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jochen Renner, University Hospital Schleswig-Holstein
- Investigators
- Jochen Renner, PD Dr., Principal investigator, University Hospital Schleswig-Holstein, Departement of Anaesthesia and Intensive Care MedicineRobert Hanss, Prof. Dr., Principal investigator, University Hospital Schleswig-Holstein, Departement of Anaesthesia and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166580
- Sponsor's protocol ID
- CNAP 2012_2
- Status last verified
- Jun 2017
- First submitted
- 4 Dec 2012
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Renner J, Gruenewald M, Hill M, Mangelsdorff L, Aselmann H, Ilies C, Steinfath M, Broch O. Non-invasive assessment of fluid responsiveness using CNAP technology is interchangeable with invasive arterial measurements during major open abdominal surgery. Br J Anaesth. 2017 Jan;118(1):58-67. doi: 10.1093/bja/aew399.
PubMed 28039242
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Non-invasive CNAP Pulse Pressure Variation With the Invasive Gold Standard
- ClinicalTrials.gov ID
- NCT02166580
- Acronym / sponsor ID
- CNAP 2012_2
- Conditions
- General Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Jun 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.
Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor.
Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.
Detailed description
Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually calculated PPV from the arterial line waveform. Established tests like passive leg raising and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative events like volume challenge are monitored.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major surgery with the need for invasive arterial pressure monitoring
Key inclusion criteria (2 listed)
- major surgery
- need for invasive arterial measurements
Key exclusion criteria (3 listed)
- age under 18
- cardiac dysrhythmia
- vascular pathology at punction site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac output
Time frame: 1, 2, 5, 10, 15 and 20 minutes after volume challange and
Improvement of cardiac output dependent on PPV before volume challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Derived from this study: PubMed 28039242Renner J, Gruenewald M, Hill M, Mangelsdorff L, Aselmann H, Ilies C, Steinfath M, Broch O. Non-invasive assessment of fluid responsiveness using CNAP technology is interchangeable with invasive arterial measurements during major open abdominal surgery. Br J Anaesth. 2017 Jan;118(1):58-67. doi: 10.1093/bja/aew399.
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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 Renner, PD Dr. principal investigator
University Hospital Schleswig-Holstein, Departement of Anaesthesia and Intensive Care Medicine
Robert Hanss, Prof. Dr. principal investigator
University Hospital Schleswig-Holstein, Departement of Anaesthesia and Intensive Care Medicine
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 General Anaesthesia, run by University Hospital Schleswig-Holstein 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jun 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac output (time frame: 1, 2, 5, 10, 15 and 20 minutes after volume challange and). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166580, which also lists 1 linked publication.
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 6 Jun 2017.