AnesthesiaNCT01658631
Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)
An observational study of Anesthesia, run by Hopital Foch at 2 sites in France.
Trial summary
The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter) during induction of general anesthesia, during a leg raising test in the Intensive Care Unit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- arterial pressure measurement (Nexfin, a noninvasive finger cuff system)
- Type of treatment
- Medical device
- How many people
- 97 participants
- Where
- 2 sitesFrance
- Study dates
- Aug 2012to Jun 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 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 and ICU patients requiring a passive legs raising test
Who may be able to join
- Age >18
- ASA II, III or IV
- weight between 40 and 180 kg; BMI < 35
- normal Allen's test and/or hand Doppler examination.
Who cannot join
- cardiac arrhythmias,
- history of vascular surgery or vascular implant in the upper limb
- Raynaud disease
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Mutualiste Montsouris
Paris, 75014
Hopital Foch
Suresnes, 92151
About this study
Official title: Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test
The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)
- during induction of general anesthesia,
- during a leg raising test in the Intensive Care Unit
- Conditions
- Anesthesia
- Being tested
- arterial pressure measurement (Nexfin, a noninvasive finger cuff system)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial pressure measurement (Nexfin, a noninvasive finger cuff system)Device
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia | Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during the induction of anesthesia Receives: Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system) | |
| Intensive Care Unit patients | Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during a passive legs raising test Receives: Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial pressure measurement
Measured: Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 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 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658631
- Sponsor's protocol ID
- 2010/42
- Other IDs
- 2010-A00881-38
- Status last verified
- Nov 2016
- First submitted
- 1 Aug 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. Use of the Nexfin device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth. 2014 Jul;113(1):52-60. doi: 10.1093/bja/aeu055. Epub 2014 Apr 25.
PubMed 24771806
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test
- ClinicalTrials.gov ID
- NCT01658631
- Acronym / sponsor ID
- 2010/42
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Aug 2012 (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 (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)
- during induction of general anesthesia,
- during a leg raising test in the Intensive Care Unit
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesia | – | Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during the induction of anesthesia |
| Intensive Care Unit patients | – | Device: arterial pressure measurement (Nexfin, a noninvasive finger cuff system)Arterial pressure measurement using Nexfin (a noninvasive finger cuff system) during a passive legs raising test |
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 and ICU patients requiring a passive legs raising test
Key inclusion criteria (4 listed)
- Age >18
- ASA II, III or IV
- weight between 40 and 180 kg; BMI < 35
- normal Allen's test and/or hand Doppler examination.
Key exclusion criteria (3 listed)
- cardiac arrhythmias,
- history of vascular surgery or vascular implant in the upper limb
- Raynaud disease
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 |
|---|---|---|
| arterial pressure measurement (Nexfin, a noninvasive finger cuff system) | Device | Anesthesia, Intensive Care Unit patients |
Primary outcome
Arterial pressure measurement
Time frame: Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes
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 3 Nov 2016.
- Derived from this study: PubMed 24771806Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. Use of the Nexfin device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth. 2014 Jul;113(1):52-60. doi: 10.1093/bja/aeu055. Epub 2014 Apr 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Hopital Foch at 2 sites 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 4 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Arterial pressure measurement (time frame: Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes). 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 NCT01658631, 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 3 Nov 2016.