Acid Base DisorderVEINARTNCT03784664
Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
A study testing Arterial blood gas and Veinous blood gas in people with Acid Base Disorder, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acid Base Disorder
- What is being tested?
- Arterial blood gas and Veinous blood gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Jan 2019to 22 Mar 2019
- 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
- necessity of blood gas analysis
- age > 18 yo
- SpO2>95% without supplemental oxygen
- no altered level of consciousness: Glasgow Coma Scale=15
Who cannot join
- Patient under guardianship or curatorship
- confusional state or patient unable to understand the protocol
- no social security
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Beaujon
Clichy, 92110
Hôpital Louis Mourier
Colombes, 95700
Hôpital Lariboisière
Paris, 75010
Hôpital Bichat
Paris, 75018
About this study
Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. Currently, several studies have already shown the existence of a good correlation of pH and bicarbonates level between a venous and arterial sample. Thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas.
Due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. Indeed, among the university hospitals affiliated to the Paris Diderot University, the emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases. Demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices.
The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.
- Conditions
- Acid Base Disorder
- Being tested
- Arterial blood gas, Veinous blood gas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gasDiagnostic test
arterial blood sample with puncture of the radial artery
Veinous blood gasDiagnostic test
veinous blood sample using peripheral venepuncture
| Study group | Role | What they receive |
|---|---|---|
| Arterial blood gas | Active comparator | Not described Receives: Diagnostic Test: Arterial blood gas |
| Veinous blood gas | Experimental | Not described Receives: Diagnostic Test: Veinous blood gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score: Visual Analog Scale
Pain is self-completed by the patient using a Visual Analog Scale. Visual Analog Scale for Pain is a continuous scale comprised of a line of 100 mm grading pain intensity anchored by "no pain" (score 0) and "worst imaginable pain" (score 100)
Measured: Immediately after blood gas sample
Secondary outcomes (5)
Number of attempts needed to obtain a blood gas sample
Measured: Immediately after blood gas sample
Number of different operators needed to obtain a blood gas sample
Measured: Immediately after blood gas sample
Ease of blood gas sampling procedure
Ease of blood gas sampling procedure assessed by the operator using a four-levels likert scale ("easy","moderate","difficult" "very difficult")
Measured: Immediately after blood gas sample
Failure of the blood gas sampling procedure
Impossibility to obtain a blood gas sample
Measured: Immediately after blood gas sample
Quality of information provided by the blood gas analysis: four levels likert scale
Four-levels likert scale assessing doctor's satisfaction regarding the quality of gas information provided by the blood gas analysis ("very satisfied","satisfied","slightly satisfied","not satisfied"
Measured: Immediately after having received blood gas analysis results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start20 Jan 2019
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
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 Acid Base DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Roux, MD,PhD, Study chair, Intensive care department, Louis Mourier hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784664
- Sponsor's protocol ID
- Assistance Publique - Hôpitaux
- Acronym
- VEINART
- Status last verified
- Dec 2018
- First submitted
- 12 Dec 2018
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chauvin A, Javaud N, Ghazali A, Curac S, Altar A, Ali T, Beguin N, Bellier J, Coupier A, Delsarte L, Dreyfuss D, Kheirbek N, Oudar C, Stordeur Y, Weiss M, Gaudry S, Lambert J, Roux D. Reducing pain by using venous blood gas instead of arterial blood gas (VEINART): a multicentre randomised controlled trial. Emerg Med J. 2020 Dec;37(12):756-761. doi: 10.1136/emermed-2019-209287. Epub 2020 Aug 5.
PubMed 32759347
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
- ClinicalTrials.gov ID
- NCT03784664
- Acronym / sponsor ID
- VEINART / Assistance Publique - Hôpitaux
- Conditions
- Acid Base Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 24 Dec 2018 (actual)
- 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.
Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. Currently, several studies have already shown the existence of a good correlation of pH and bicarbonates level between a venous and arterial sample. Thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas.
Due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. Indeed, among the university hospitals affiliated to the Paris Diderot University, the emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases. Demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices.
The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arterial blood gas | Active comparator | Diagnostic Test: Arterial blood gas |
| Veinous blood gas | Experimental | Diagnostic Test: Veinous blood gas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- necessity of blood gas analysis
- age > 18 yo
- SpO2>95% without supplemental oxygen
- no altered level of consciousness: Glasgow Coma Scale=15
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- confusional state or patient unable to understand the protocol
- no social security
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 blood gasarterial blood sample with puncture of the radial artery | Diagnostic test | Arterial blood gas |
| Veinous blood gasveinous blood sample using peripheral venepuncture | Diagnostic test | Veinous blood gas |
Primary outcome
Pain score: Visual Analog Scale
Time frame: Immediately after blood gas sample
Pain is self-completed by the patient using a Visual Analog Scale. Visual Analog Scale for Pain is a continuous scale comprised of a line of 100 mm grading pain intensity anchored by "no pain" (score 0) and "worst imaginable pain" (score 100)
5 secondary outcomes
Number of attempts needed to obtain a blood gas sample
Time frame: Immediately after blood gas sample
Number of different operators needed to obtain a blood gas sample
Time frame: Immediately after blood gas sample
Ease of blood gas sampling procedure
Time frame: Immediately after blood gas sample
Failure of the blood gas sampling procedure
Time frame: Immediately after blood gas sample
Quality of information provided by the blood gas analysis: four levels likert scale
Time frame: Immediately after having received blood gas analysis results
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 19 Jun 2019.
- Derived from this study: PubMed 32759347Chauvin A, Javaud N, Ghazali A, Curac S, Altar A, Ali T, Beguin N, Bellier J, Coupier A, Delsarte L, Dreyfuss D, Kheirbek N, Oudar C, Stordeur Y, Weiss M, Gaudry S, Lambert J, Roux D. Reducing pain by using venous blood gas instead of arterial blood gas (VEINART): a multicentre randomised controlled trial. Emerg Med J. 2020 Dec;37(12):756-761. doi: 10.1136/emermed-2019-209287. Epub 2020 Aug 5.
- Individual participant dataSharing planned: Undecided
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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.
Damien Roux, MD,PhD study chair
Intensive care department, Louis Mourier hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial blood gas and Veinous blood gas in people with Acid Base Disorder, run by Assistance Publique - Hôpitaux de Paris at 4 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Pain score: Visual Analog Scale (time frame: Immediately after blood gas sample). 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 NCT03784664, 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 19 Jun 2019.