Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas (VEINART)

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 Overview

• Status: Completed
• Conditions: Acid Base Disorder
• Intervention / Treatment: Diagnostic test: Arterial blood gas; Diagnostic test: Veinous blood gas

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92110
    • Hopital Beaujon
  • Colombes, France, 95700
    • Hopital Louis Mourier
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75018
    • Hopital Bichat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arterial blood gas	Diagnostic test: Arterial blood gas; arterial blood sample with puncture of the radial artery
EXPERIMENTAL: Veinous blood gas	Diagnostic test: Veinous blood gas; veinous blood sample using peripheral venepuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Immediately after blood gas sample

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts needed to obtain a blood gas sample		Immediately after blood gas sample
Number of different operators needed to obtain a blood gas sample		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")	Immediately after blood gas sample
Failure of the blood gas sampling procedure	Impossibility to obtain a blood gas sample	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"	Immediately after having received blood gas analysis results

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Damien Roux, MD,PhD, Intensive care department, Louis Mourier hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2019
• Primary Completion (ACTUAL): March 22, 2019
• Study Completion (ACTUAL): March 22, 2019

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (ACTUAL): December 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: Assistance Publique - Hôpitaux

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No