General AnesthesiaCnapEvalNCT01032226
Evaluation of CNAP During Anesthesia
An observational study of General Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
The purpose of this study is to compare the non invasive measurement of arterial pressure (CNAP monitor) with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Mar 2011
- 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 major surgery with the need for an invasive blood pressure measurement
Who may be able to join
- Age >18
- ASA II, III or IV
- weight between 40 and 180 kg; BMI < 35
- surgical procedure performed in supine position
- normal Allen's test and hand Doppler examination.
Who cannot join
- cardiac arrhythmias,
- history of vascular surgery or vascular implant in the upper limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of CNAP During Induction and Maintenance of General Anesthesia
The purpose of this study is to compare
- the non invasive measurement of arterial pressure (CNAP monitor)
- with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia
- Conditions
- General Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between both methods of arterial pressure measurement
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Difficulty to include more patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032226
- Sponsor's protocol ID
- 2009/03
- Acronym
- CnapEval
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CNAP During Induction and Maintenance of General Anesthesia
- ClinicalTrials.gov ID
- NCT01032226
- Acronym / sponsor ID
- CnapEval / 2009/03
- Conditions
- General Anesthesia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty to include more patients
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Dec 2009 (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.
The purpose of this study is to compare
- the non invasive measurement of arterial pressure (CNAP monitor)
- with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major surgery with the need for an invasive blood pressure measurement
Key inclusion criteria (5 listed)
- Age >18
- ASA II, III or IV
- weight between 40 and 180 kg; BMI < 35
- surgical procedure performed in supine position
- normal Allen's test and hand Doppler examination.
Key exclusion criteria (2 listed)
- cardiac arrhythmias,
- history of vascular surgery or vascular implant in the upper limb
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
Comparison between both methods of arterial pressure measurement
Time frame: intraoperative
Results and safety
The study was stopped early (reason given: Difficulty to include more patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Marc Fischler, MD study chair
Hôpital Foch
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 Anesthesia, run by Hopital Foch at 1 site in France.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Sep 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 France. 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 stopped early (reason given: Difficulty to include more patients). Results are not available in the source record.
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?
Comparison between both methods of arterial pressure measurement (time frame: intraoperative). 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 23 Sep 2016.