NCT03784664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

June 19, 2019

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

December 12, 2018

Last Update Submit

June 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    Immediately after blood gas sample

  • Failure of the blood gas sampling procedure

    Immediately after blood gas sample

  • Quality of information provided by the blood gas analysis: four levels likert scale

    Immediately after having received blood gas analysis results

Study Arms (2)

Arterial blood gas

ACTIVE COMPARATOR
Diagnostic Test: Arterial blood gas

Veinous blood gas

EXPERIMENTAL
Diagnostic Test: Veinous blood gas

Interventions

Arterial blood gasDIAGNOSTIC_TEST

arterial blood sample with puncture of the radial artery

Arterial blood gas
Veinous blood gasDIAGNOSTIC_TEST

veinous blood sample using peripheral venepuncture

Veinous blood gas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Louis Mourier

Colombes, 95700, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Blood Gas Analysis

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Officials

  • Damien Roux, MD,PhD

    Intensive care department, Louis Mourier hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 24, 2018

Study Start

January 20, 2019

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

June 19, 2019

Record last verified: 2018-12

Locations