AnesthesiaNICOM-VALNCT02485457
Validation of Nicom Device to Measure Stoke Volume Variation
A study testing Volume loading and Ringer solution in people with Anesthesia, run by Hopital Foch at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Volume loading and Ringer solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Jun 2015to 12 Jun 2017
- Phase
- Interventional
- 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
Who may be able to join
- patients undergoing general anesthesia with an expected duration exceeding two hours
- gastrointestinal surgery, urological or gynecological surgery.
Who cannot join
- Difficulty of venous access.
- Contraindication for the use of oesophageal Doppler
- Contraindication for the use of Nicom
- Contraindication for the use of bispectral index
- Pregnant or lactating women
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Validation of NICOM for the Detection of Modification of Stroke Volume
The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery
- Conditions
- Anesthesia
- Being tested
- Volume loading, Ringer solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume loadingProcedure or surgery
Volume loading with Ringer Lactate
Ringer solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Low volume | Experimental | The protocol will follow the following steps :
* basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by low volume loading (250 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) Receives: Procedure: Volume loading; Drug: Ringer solution |
| High volume | Experimental | The protocol will follow the following steps :
* basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
* followed by low volume loading (500 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) Receives: Procedure: Volume loading; Drug: Ringer solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume variation
Stroke volumes measured by esophageal Doppler and by Nicom: at baseline, after leg passive rising, and after volume loading
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start28 Jun 2015
- Primary completion12 Jun 2017
- Study completion12 Jun 2017
Why it stopped: Difficulties of recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 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
- NCT02485457
- Sponsor's protocol ID
- 2014/17
- Acronym
- NICOM-VAL
- Status last verified
- Jan 2018
- First submitted
- 26 Jun 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of NICOM for the Detection of Modification of Stroke Volume
- ClinicalTrials.gov ID
- NCT02485457
- Acronym / sponsor ID
- NICOM-VAL / 2014/17
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of recrutment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 28 Jun 2015 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 30 Jun 2015 (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 evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low volume | Experimental | Procedure: Volume loading, Drug: Ringer solutionThe protocol will follow the following steps : * basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) * followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) * second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) * followed by low volume loading (250 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) |
| High volume | Experimental | Procedure: Volume loading, Drug: Ringer solutionThe protocol will follow the following steps : * basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) * followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) * second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) * followed by low volume loading (500 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing general anesthesia with an expected duration exceeding two hours
- gastrointestinal surgery, urological or gynecological surgery.
Key exclusion criteria (5 listed)
- Difficulty of venous access.
- Contraindication for the use of oesophageal Doppler
- Contraindication for the use of Nicom
- Contraindication for the use of bispectral index
- Pregnant or lactating women
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 |
|---|---|---|
| Volume loadingVolume loading with Ringer Lactate | Procedure or surgery | High volume, Low volume |
| Ringer solution | Drug | High volume, Low volume |
Primary outcome
Stroke volume variation
Time frame: 6 hours
Stroke volumes measured by esophageal Doppler and by Nicom: at baseline, after leg passive rising, and after volume loading
Results and safety
The study was stopped early (reason given: Difficulties of recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
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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?
A study testing Volume loading and Ringer solution in people with 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 2 inclusion and 5 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 29 Jan 2018. 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 was stopped early (reason given: Difficulties of recrutment). 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?
Stroke volume variation (time frame: 6 hours). 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 29 Jan 2018.