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

Primary Purpose

Acid Base Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arterial blood gas
Veinous blood gas
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acid Base Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Beaujon
  • Hôpital Louis Mourier
  • Hôpital Lariboisière
  • Hôpital Bichat

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arterial blood gas

Veinous blood gas

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of attempts needed to obtain a blood gas sample
Number of different operators needed to obtain a 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")
Failure of the blood gas sampling procedure
Impossibility to obtain a 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"

Full Information

First Posted
December 12, 2018
Last Updated
June 18, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03784664
Brief Title
Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
Acronym
VEINART
Official Title
Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acid Base Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arterial blood gas
Arm Type
Active Comparator
Arm Title
Veinous blood gas
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Arterial blood gas
Intervention Description
arterial blood sample with puncture of the radial artery
Intervention Type
Diagnostic Test
Intervention Name(s)
Veinous blood gas
Intervention Description
veinous blood sample using peripheral venepuncture
Primary Outcome Measure Information:
Title
Pain score: Visual Analog Scale
Description
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)
Time Frame
Immediately after blood gas sample
Secondary Outcome Measure Information:
Title
Number of attempts needed to obtain a blood gas sample
Time Frame
Immediately after blood gas sample
Title
Number of different operators needed to obtain a blood gas sample
Time Frame
Immediately after blood gas sample
Title
Ease of blood gas sampling procedure
Description
Ease of blood gas sampling procedure assessed by the operator using a four-levels likert scale ("easy","moderate","difficult" "very difficult")
Time Frame
Immediately after blood gas sample
Title
Failure of the blood gas sampling procedure
Description
Impossibility to obtain a blood gas sample
Time Frame
Immediately after blood gas sample
Title
Quality of information provided by the blood gas analysis: four levels likert scale
Description
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"
Time Frame
Immediately after having received blood gas analysis results

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien Roux, MD,PhD
Organizational Affiliation
Intensive care department, Louis Mourier hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
95700
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32759347
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.
Results Reference
derived

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

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