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

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ClinicalTrials.gov Identifier: NCT03784664
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE January 20, 2019
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • 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 ]
    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 [ Time Frame: Immediately after blood gas sample ]
    Impossibility to obtain a 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 ]
    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"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
Official Title  ICMJE Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Acid Base Disorder
Intervention  ICMJE
  • Diagnostic Test: Arterial blood gas
    arterial blood sample with puncture of the radial artery
  • Diagnostic Test: Veinous blood gas
    veinous blood sample using peripheral venepuncture
Study Arms  ICMJE
  • Active Comparator: Arterial blood gas
    Intervention: Diagnostic Test: Arterial blood gas
  • Experimental: Veinous blood gas
    Intervention: Diagnostic Test: Veinous blood gas
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 22, 2019
Actual Primary Completion Date March 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03784664
Other Study ID Numbers  ICMJE Assistance Publique - Hôpitaux
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Damien Roux, MD,PhD Intensive care department, Louis Mourier hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP