Clinical trial NCT03784664: Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
Official title: Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acid Base Disorder
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* necessity of blood gas analysis
* age \> 18 yo
* SpO2\>95% without supplemental oxygen
* no altered level of consciousness: Glasgow Coma Scale=15

Exclusion Criteria:

* Patient under guardianship or curatorship
* confusional state or patient unable to understand the protocol
* no social security

Primary outcomes:
measure: Pain score: Visual Analog Scale
timeFrame: Immediately after blood gas sample
Secondary outcomes:
measure: Number of attempts needed to obtain a blood gas sample
timeFrame: Immediately after blood gas sample
measure: Number of different operators needed to obtain a blood gas sample
timeFrame: Immediately after blood gas sample
measure: Ease of blood gas sampling procedure
timeFrame: Immediately after blood gas sample
measure: Failure of the blood gas sampling procedure
timeFrame: Immediately after blood gas sample
measure: Quality of information provided by the blood gas analysis: four levels likert scale
timeFrame: Immediately after having received blood gas analysis results
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Bichat
Study officials:
affiliation: Intensive care department, Louis Mourier hospital
name: Damien Roux, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.