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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Acid Base Disorder Diagnostic Test: Arterial blood gas Diagnostic Test: Veinous blood gas Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas
Actual Study Start Date : January 20, 2019
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of attempts needed to obtain a blood gas sample [ Time Frame: Immediately after blood gas sample ]
  2. Number of different operators needed to obtain a blood gas sample [ Time Frame: Immediately after blood gas sample ]
  3. 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")

  4. Failure of the blood gas sampling procedure [ Time Frame: Immediately after blood gas sample ]
    Impossibility to obtain a blood gas sample

  5. 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"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784664


Locations
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France
Hôpital Beaujon
Clichy, France, 92110
Hôpital Louis Mourier
Colombes, France, 95700
Hôpital Lariboisière
Paris, France, 75010
Hôpital Bichat
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Damien Roux, MD,PhD Intensive care department, Louis Mourier hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03784664    
Other Study ID Numbers: Assistance Publique - Hôpitaux
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes