xml: <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/NCT06008509</url>
    </required_header>
    <id_info>
      <org_study_id>221116005</org_study_id>
      <nct_id>NCT06008509</nct_id>
    </id_info>
    <brief_title>POCUS for Gastric Emptying in Emergency Surgery</brief_title>
    <acronym>EcoGastric</acronym>
    <official_title>Determination of Gastric Content Using Ultrasonography in Patients Undergoing Emergency Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pontificia Universidad Catolica de Chile</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pontificia Universidad Catolica de Chile</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>
        The goal of this clinical trial is to learn about the gastric emptying in adult patients that&#xD;
        are going to operatin theatre due to an abdominal acute disease, for instance, intestinal&#xD;
        obstruction or cholecystitis. This kind of patients are traditionally considered as a full&#xD;
        stomach and the induction of anesthesia include rapid sequence intubation (RSI) in order to&#xD;
        decrease the risk of aspiration . However, image technologies, like echography, allow the&#xD;
        visualization of the stomach and to measure the amount and characteristics of the content&#xD;
        lodged in the stomach. This information is vital to decide if RSI is necesary or not. The&#xD;
        main question[s] it aims to answer are:&#xD;
  &#xD;
          -  What is the percentages of full stomach in patient who come to the operating room due an&#xD;
             abodiminal acute disease?&#xD;
  &#xD;
          -  Are different variables, namely, time since diagnosis, use of antibiotics or non&#xD;
             steroidal antiinflamatory drugs related with the content of the stomach? Participants&#xD;
             will be evaluated with ecography to determinate the amount of content of the stomach&#xD;
             before the surgery in the operating room.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The pulmonary aspiration of gastric contents is a serious anesthetic complication with high&#xD;
        associated morbidity and mortality. Its incidence is estimated to be between 0.1% and 19% of&#xD;
        cases of general anesthesia. It is associated with admission to intensive care units,&#xD;
        prolonged mechanical ventilation, and mortality, which can reach up to 5%. On the other hand,&#xD;
        it accounts for 9% of anesthesia-related death). Given this, in patients at risk of&#xD;
        aspiration, such as non-compliance with fasting or acute abdominal pathology, rapid sequence&#xD;
        induction is routinely used. However, this technique is not without risks, being associated&#xD;
        with episodes of desaturation, hyperkalemia, among others. Therefore, it is reasonable to&#xD;
        question the widespread use of this technique in all urgent surgeries for acute abdominal&#xD;
        pathologies, based solely on the pathophysiological concept that inflammation and pain could&#xD;
        be associated with delayed gastric emptying and therefore a higher risk of aspiration,&#xD;
        especially in high-risk populations for desaturation and difficult airway, such as pediatric&#xD;
        patients or pregnant women.&#xD;
  &#xD;
        The use of ultrasound for determining gastric content is a feasible tool to assess the risk&#xD;
        of aspiration. The best results have been obtained using curved transducers, with the patient&#xD;
        in a semi-sitting or right lateral decubitus position, where the evaluation of the gastric&#xD;
        antrum has shown better sensitivity in detecting content in patients with prolonged fasting.&#xD;
        Multiple studies have been conducted in adult and pediatric patients, including obstetric and&#xD;
        obese patients, for whom the technique could be more challenging, achieving high sensitivity&#xD;
        and specificity in determining gastric content with ultrasound based on standardized&#xD;
        measurements of the antrum. The purpose of this study is to describe the percentage of&#xD;
        patients that have full stomach just befor the induction of the anesthesia and to evaluate if&#xD;
        preoperatory treatments and time since the diagnosis are related with the gastric emptying.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Descriptive study where patients are going to recieve and abdominal image exam (gastric Ultrasound)</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients with properative full stomach and type of content that they present</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Number of patients that present full stomach determinated by a mathematical formula obtained by a prior study of Perlas et al, according to the gastric perimeter measured in centimeters. In case of the stomach present content by the formula, the contet will be described in three categories: Solid, liquid or difusse.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>To relate the Number of patients with full stomach and numer of patients with diferent variables collected in the preoperative period, for example: number of fasting hours (continue variable in hours), use of antibiotics (yes or no), use of analgesic (yes or no).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Gastric Emptying</condition>
    <condition>Abdomen, Acute</condition>
    <arm_group>
      <arm_group_label>Gastric Echography</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All the patients that entry to the study are going to recieve gastric echography to determine the level of gastric emptying before the induction of anesthesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Gastric echography preoperative</intervention_name>
      <description>Patients with acute abdomen that are going to surgery, are going to recieve a gastric echography in the surgery room before the start of anesthesia. This procedure include vision of the stomach during supine position and lateral position with curve transductor.</description>
      <arm_group_label>Gastric Echography</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults patients&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  Diagnosis of Acute Abdomen&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Younger than 18 years old&#xD;
  &#xD;
            -  No posibility of adopt lateral decubitus.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Juan Carlos De la Cuadra, Assosiate Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Pontificia Universidad Catolica de Chile</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alejandro luengo, clinical professor</last_name>
      <phone>+56990951086</phone>
      <email>ajluengo@uc.cl</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Pontificia Universidad Catolica de Chile</investigator_affiliation>
      <investigator_full_name>Alejandro Luengo</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Abdomen, Acute</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 1, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT06008509/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008509
  org study id: 221116005
  nct id: NCT06008509
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the gastric emptying in adult patients that
        are going to operatin theatre due to an abdominal acute disease, for instance, intestinal
        obstruction or cholecystitis. This kind of patients are traditionally considered as a full
        stomach and the induction of anesthesia include rapid sequence intubation (RSI) in order to
        decrease the risk of aspiration . However, image technologies, like echography, allow the
        visualization of the stomach and to measure the amount and characteristics of the content
        lodged in the stomach. This information is vital to decide if RSI is necesary or not. The
        main question[s] it aims to answer are:
  
          -  What is the percentages of full stomach in patient who come to the operating room due an
             abodiminal acute disease?
  
          -  Are different variables, namely, time since diagnosis, use of antibiotics or non
             steroidal antiinflamatory drugs related with the content of the stomach? Participants
             will be evaluated with ecography to determinate the amount of content of the stomach
             before the surgery in the operating room.
  The pulmonary aspiration of gastric contents is a serious anesthetic complication with high
        associated morbidity and mortality. Its incidence is estimated to be between 0.1% and 19% of
        cases of general anesthesia. It is associated with admission to intensive care units,
        prolonged mechanical ventilation, and mortality, which can reach up to 5%. On the other hand,
        it accounts for 9% of anesthesia-related death). Given this, in patients at risk of
        aspiration, such as non-compliance with fasting or acute abdominal pathology, rapid sequence
        induction is routinely used. However, this technique is not without risks, being associated
        with episodes of desaturation, hyperkalemia, among others. Therefore, it is reasonable to
        question the widespread use of this technique in all urgent surgeries for acute abdominal
        pathologies, based solely on the pathophysiological concept that inflammation and pain could
        be associated with delayed gastric emptying and therefore a higher risk of aspiration,
        especially in high-risk populations for desaturation and difficult airway, such as pediatric
        patients or pregnant women.
  
        The use of ultrasound for determining gastric content is a feasible tool to assess the risk
        of aspiration. The best results have been obtained using curved transducers, with the patient
        in a semi-sitting or right lateral decubitus position, where the evaluation of the gastric
        antrum has shown better sensitivity in detecting content in patients with prolonged fasting.
        Multiple studies have been conducted in adult and pediatric patients, including obstetric and
        obese patients, for whom the technique could be more challenging, achieving high sensitivity
        and specificity in determining gastric content with ultrasound based on standardized
        measurements of the antrum. The purpose of this study is to describe the percentage of
        patients that have full stomach just befor the induction of the anesthesia and to evaluate if
        preoperatory treatments and time since the diagnosis are related with the gastric emptying.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Descriptive study where patients are going to recieve and abdominal image exam (gastric Ultrasound)
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Number of patients with properative full stomach and type of content that they present
  time frame: Through study completion, an average of 1 year
  description: Number of patients that present full stomach determinated by a mathematical formula obtained by a prior study of Perlas et al, according to the gastric perimeter measured in centimeters. In case of the stomach present content by the formula, the contet will be described in three categories: Solid, liquid or difusse.
  measure: Relation between some interventions, for instance: use of antibiotics, antiinflamatory drugs and time of fasting with gastric emptying.
  time frame: through study completion, an average of 1 year
  description: To relate the Number of patients with full stomach and numer of patients with diferent variables collected in the preoperative period, for example: number of fasting hours (continue variable in hours), use of antibiotics (yes or no), use of analgesic (yes or no).
  arm group label: Gastric Echography
  arm group type: Experimental
  description: All the patients that entry to the study are going to recieve gastric echography to determine the level of gastric emptying before the induction of anesthesia.
  intervention type: Procedure
  intervention name: Gastric echography preoperative
  description: Patients with acute abdomen that are going to surgery, are going to recieve a gastric echography in the surgery room before the start of anesthesia. This procedure include vision of the stomach during supine position and lateral position with curve transductor.
  arm group label: Gastric Echography
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Juan Carlos De la Cuadra, Assosiate Professor
  role: Study Chair
  affiliation: Pontificia Universidad Catolica de Chile
  last name: Alejandro luengo, clinical professor
  phone: +56990951086
  email: ajluengo@uc.cl
  responsible party type: Principal Investigator
  investigator affiliation: Pontificia Universidad Catolica de Chile
  investigator full name: Alejandro Luengo
  investigator title: Clinical Professor
  mesh term: Emergencies
  mesh term: Abdomen, Acute
  provided document: 