<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03784664</url>
  </required_header>
  <id_info>
    <org_study_id>Assistance Publique - Hôpitaux</org_study_id>
    <nct_id>NCT03784664</nct_id>
  </id_info>
  <brief_title>Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas</brief_title>
  <acronym>VEINART</acronym>
  <official_title>Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blood gases are widely used in emergency and resuscitation services and are the key&#xD;
      examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas&#xD;
      exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and&#xD;
      arterial sample and its analysis depends on the type of blood sample. Currently, several&#xD;
      studies have already shown the existence of a good correlation of pH and bicarbonates level&#xD;
      between a venous and arterial sample. Thus, when this examination is prescribed for the&#xD;
      purpose of highlighting and analyzing an acid-base disorder, venous blood gas is&#xD;
      theoretically as efficient as arterial blood gas.&#xD;
&#xD;
      Due to the lack of evidence of benefit for the patient or the health care team of a venous&#xD;
      blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia,&#xD;
      arterial blood gas is currently the standard of care for the analysis of acid-base disorders.&#xD;
      Indeed, among the university hospitals affiliated to the Paris Diderot University, the&#xD;
      emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases.&#xD;
      Demonstration of the superiority of veinous sample over arterial sample regarding pain could&#xD;
      substantially modify current practices.&#xD;
&#xD;
      The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal&#xD;
      oxygen saturation measured by plethysmography), the realization of a venous blood gas for the&#xD;
      evaluation of the acid-base balance in the context of emergencies is less painful for&#xD;
      patients, simpler for the health care team and provides sufficient biochemical information&#xD;
      for the doctor in comparison with an arterial blood gas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">March 22, 2019</completion_date>
  <primary_completion_date type="Actual">March 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score: Visual Analog Scale</measure>
    <time_frame>Immediately after blood gas sample</time_frame>
    <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 &quot;no pain&quot; (score 0) and &quot;worst imaginable pain&quot; (score 100)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of attempts needed to obtain a blood gas sample</measure>
    <time_frame>Immediately after blood gas sample</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of different operators needed to obtain a blood gas sample</measure>
    <time_frame>Immediately after blood gas sample</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of blood gas sampling procedure</measure>
    <time_frame>Immediately after blood gas sample</time_frame>
    <description>Ease of blood gas sampling procedure assessed by the operator using a four-levels likert scale (&quot;easy&quot;,&quot;moderate&quot;,&quot;difficult&quot; &quot;very difficult&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure of the blood gas sampling procedure</measure>
    <time_frame>Immediately after blood gas sample</time_frame>
    <description>Impossibility to obtain a blood gas sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of information provided by the blood gas analysis: four levels likert scale</measure>
    <time_frame>Immediately after having received blood gas analysis results</time_frame>
    <description>Four-levels likert scale assessing doctor's satisfaction regarding the quality of gas information provided by the blood gas analysis (&quot;very satisfied&quot;,&quot;satisfied&quot;,&quot;slightly satisfied&quot;,&quot;not satisfied&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Acid Base Disorder</condition>
  <arm_group>
    <arm_group_label>Arterial blood gas</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Veinous blood gas</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Arterial blood gas</intervention_name>
    <description>arterial blood sample with puncture of the radial artery</description>
    <arm_group_label>Arterial blood gas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Veinous blood gas</intervention_name>
    <description>veinous blood sample using peripheral venepuncture</description>
    <arm_group_label>Veinous blood gas</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  necessity of blood gas analysis&#xD;
&#xD;
          -  age &gt; 18 yo&#xD;
&#xD;
          -  SpO2&gt;95% without supplemental oxygen&#xD;
&#xD;
          -  no altered level of consciousness: Glasgow Coma Scale=15&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  confusional state or patient unable to understand the protocol&#xD;
&#xD;
          -  no social security&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damien Roux, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Intensive care department, Louis Mourier hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>95700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784664
org study id: Assistance Publique - Hôpitaux
nct id: NCT03784664
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Pain score: Visual Analog Scale
time frame: Immediately after blood gas sample
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)
measure: Number of attempts needed to obtain a blood gas sample
time frame: Immediately after blood gas sample
measure: Number of different operators needed to obtain a blood gas sample
time frame: Immediately after blood gas sample
measure: Ease of blood gas sampling procedure
time frame: Immediately after blood gas sample
description: Ease of blood gas sampling procedure assessed by the operator using a four-levels likert scale ("easy","moderate","difficult" "very difficult")
measure: Failure of the blood gas sampling procedure
time frame: Immediately after blood gas sample
description: Impossibility to obtain a blood gas sample
measure: Quality of information provided by the blood gas analysis: four levels likert scale
time frame: Immediately after having received blood gas analysis results
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"
arm group label: Arterial blood gas
arm group type: Active Comparator
arm group label: Veinous blood gas
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Arterial blood gas
description: arterial blood sample with puncture of the radial artery
arm group label: Arterial blood gas
intervention type: Diagnostic Test
intervention name: Veinous blood gas
description: veinous blood sample using peripheral venepuncture
arm group label: Veinous blood gas
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Damien Roux, MD,PhD
role: Study Chair
affiliation: Intensive care department, Louis Mourier hospital
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: Undecided