<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/NCT03802643</url>
  </required_header>
  <id_info>
    <org_study_id>530/2018/OSS/AOUPR</org_study_id>
    <nct_id>NCT03802643</nct_id>
  </id_info>
  <brief_title>Preoxygenation Before General Anesthesia</brief_title>
  <acronym>PREOX2018</acronym>
  <official_title>Assessment of Oxygenation Values Before General Anesthesia in Elective Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Parma</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale of the study: we aim to clarify the question (related to still unclear and not&#xD;
      univocal response) about the protective or unnecessary role of preoxygenation in&#xD;
      non-critically ill patients (otherwise with no high risk of desaturation) undergoing general&#xD;
      anesthesia before elective surgery.&#xD;
&#xD;
      It will be also necessary differentiate the development of postoperative complications&#xD;
      (pulmonary, cardiovascular, neurological, surgical) due to preoxygenation from the ones&#xD;
      related with patient comorbidity, intraoperative and surgical causes, tube disconnection.&#xD;
&#xD;
      Procedure: patient's informed consent signature for adhesion at the study will be initially&#xD;
      requested. With their acceptance, parameters will be recorded anonymously in the Case Report&#xD;
      Form, identified by their initials and an alphanumeric code, until hospital discharge.&#xD;
&#xD;
      The parameters analyzed will be related to:&#xD;
&#xD;
        -  preoperative evaluation; about anamnesis, health general conditions, blood oxygen&#xD;
           saturation (Sat02), Metabolic Equivalent of Task (METs)&#xD;
&#xD;
        -  intraoperative evaluation; about oxygenations values, recorded before/during induction&#xD;
           and maintenance of general anesthesia&#xD;
&#xD;
        -  postoperative evaluation; about postoperative complications, pulmonary primarily, and&#xD;
           secondary cardiovascular, neurological and surgical, based on the medical record.&#xD;
&#xD;
      The data wil be transferred on Excel worksheet, utilized for descriptive analysis related at&#xD;
      every variable. By multivariate logistic regression will be evaluated the major factors&#xD;
      influencing postoperative pulmonary complications (PPCs) onset in patients undergoing&#xD;
      preoxygenation for elective surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background of the study:&#xD;
&#xD;
      Preoxygenation is a widely used technique that improves the safety of endotracheal&#xD;
      intubation. The procedure is carried out by supplying 100% oxygen (FiO2 of 1.0) before the&#xD;
      induction of general anesthesia until both end-tidal oxygen (EtO2)&gt;90% and end-tidal N2&#xD;
      (EtN2)&lt;5% are reached. Both these markers define the efficacy of the procedure. As a result,&#xD;
      the lung oxygen content is increased far beyond normal oxygen consumption by saturating the&#xD;
      functional residual capacity with 100% oxygen. This allows for a longer safe apnea time (i.e.&#xD;
      the time required for oxyhemoglobin saturation to drop below 90%). The rate at which&#xD;
      oxyhemoglobin saturation drops during apnea indicates the efficiency of the maneuver.&#xD;
&#xD;
      This procedure is strongly recommended for all patients undergoing general anesthesia since&#xD;
      it lengthens safe laryngoscopy time and grants a wider timeframe to respond to a &quot;cannot&#xD;
      intubate/cannot oxygenate&quot; (CICO) scenario, a rare yet life threatening situation. It remains&#xD;
      unclear whether this should be considered mandatory for non-critically ill and non-obese&#xD;
      patients since their oxygen reserves should suffice for the time required to perform&#xD;
      endotracheal intubation or regain spontaneous breathing in the event of a CICO scenario.&#xD;
      Nonetheless, the guidelines for the management of endotracheal intubation, proposed by the&#xD;
      Difficult Airway Society in 2015 United Kingdom state how it is pivotal to preoxygenate every&#xD;
      patient before attempting to intubate. Several methods of preoxygenation have been validated&#xD;
      and compared according to duration of safe apnea time, duration of the procedure, success&#xD;
      rate (defined as &quot;avoiding manual re-ventilation&quot;), and patient tolerance. The choice between&#xD;
      these techniques is based on patient characteristics (age, sex, Body Mass Index, American&#xD;
      Society of Anesthesiologist score, Cormack-Lehane grade and Glasgow Coma Scale), settings&#xD;
      (e.g., operating room, Intensive Care Unit, emergency situations), equipment, and&#xD;
      anesthesiologist's preferences. The two standard approaches are six deep breaths in 1 min and&#xD;
      tidal volume breathing for three to 5 min, both at 100% inspired oxygen via a face mask.&#xD;
&#xD;
      The main side effect of preoxygenation is absorption atelectasis that occurs when delivering&#xD;
      100% inspired oxygen. This can be avoided using a lower inspired oxygen concentration (90%),&#xD;
      positive pressure techniques, and/or recruitment maneuvers post-endotracheal intubation. Due&#xD;
      to the short duration of the procedure, the production of reactive oxygen species and&#xD;
      cardiovascular responses are minimal and should not prevent routine preoxygenation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">January 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>Evaluation of preoxygenation use in elective surgery, reporting oxygenations values</measure>
    <time_frame>From before induction of general anesthesia until the end of surgical procedure, up to 10 hours</time_frame>
    <description>Assessment of its efficacy and efficiency in non-critically ill patients, reporting blood oxygen levels just before induction, during induction and maintenance of general anesthesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of postoperative pulmonary complications (PPC) related to preoxygenation</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
    <description>Differentiating PPCs due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of intraoperative desaturation/hypoxia</measure>
    <time_frame>From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cardiovascular postoperative complications</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of neurological postoperative complications</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of surgical postoperative complications</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Intensive Care Unit admission and its duration</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of length of in-hospital stay</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Anesthesia</condition>
  <condition>Preoxygenation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Non-critically ill patients (with no high risk of desaturation) undergoing general&#xD;
        anesthesia before elective surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent signature&#xD;
&#xD;
          -  eligible for preoxygenation before general anesthesia, in elective surgery&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  surgery duration &gt; 30 min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency/urgent surgery&#xD;
&#xD;
          -  severe respiratory disease: Chronic Obstructive Pulmonary Disease stages III-IV,&#xD;
             pulmonary fibrosis, documented bullous emphysema, severe emphysema, pneumothorax&#xD;
&#xD;
          -  uncontrolled asthma&#xD;
&#xD;
          -  severe cardiac disease: Heart Failure stages III-IV (New York Heart Association),&#xD;
             coronary artery disease stages III-IV (Canadian Cardiovascular Society)&#xD;
&#xD;
          -  previous thoracic surgery&#xD;
&#xD;
          -  pregnancy (excluded by anamnesis or laboratory test)&#xD;
&#xD;
          -  informed consent refusal&#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>Michela Tosi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benedetta Siroli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samantha Gorgoglione, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valentina Bellini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonardo Fortunati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea Parodi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea Briolini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elena Giovanna Bignami, Professor of Anesthesiology</last_name>
    <phone>+390521033609</phone>
    <email>elenagiovanna.bignami@unipr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elena Giovanna Bignami, MD Professor</last_name>
      <phone>+390521033609</phone>
      <email>elenagiovanna.bignami@unipr.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Elena Giovanna Bignami</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Oximetry</keyword>
  <keyword>Desaturation of Blood</keyword>
  <keyword>Postoperative pulmonary complications</keyword>
  <!-- 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/NCT03802643
org study id: 530/2018/OSS/AOUPR
nct id: NCT03802643
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Rationale of the study: we aim to clarify the question (related to still unclear and not
      univocal response) about the protective or unnecessary role of preoxygenation in
      non-critically ill patients (otherwise with no high risk of desaturation) undergoing general
      anesthesia before elective surgery.

      It will be also necessary differentiate the development of postoperative complications
      (pulmonary, cardiovascular, neurological, surgical) due to preoxygenation from the ones
      related with patient comorbidity, intraoperative and surgical causes, tube disconnection.

      Procedure: patient's informed consent signature for adhesion at the study will be initially
      requested. With their acceptance, parameters will be recorded anonymously in the Case Report
      Form, identified by their initials and an alphanumeric code, until hospital discharge.

      The parameters analyzed will be related to:

        -  preoperative evaluation; about anamnesis, health general conditions, blood oxygen
           saturation (Sat02), Metabolic Equivalent of Task (METs)

        -  intraoperative evaluation; about oxygenations values, recorded before/during induction
           and maintenance of general anesthesia

        -  postoperative evaluation; about postoperative complications, pulmonary primarily, and
           secondary cardiovascular, neurological and surgical, based on the medical record.

      The data wil be transferred on Excel worksheet, utilized for descriptive analysis related at
      every variable. By multivariate logistic regression will be evaluated the major factors
      influencing postoperative pulmonary complications (PPCs) onset in patients undergoing
      preoxygenation for elective surgery
Background of the study:

      Preoxygenation is a widely used technique that improves the safety of endotracheal
      intubation. The procedure is carried out by supplying 100% oxygen (FiO2 of 1.0) before the
      induction of general anesthesia until both end-tidal oxygen (EtO2)>90% and end-tidal N2
      (EtN2)<5% are reached. Both these markers define the efficacy of the procedure. As a result,
      the lung oxygen content is increased far beyond normal oxygen consumption by saturating the
      functional residual capacity with 100% oxygen. This allows for a longer safe apnea time (i.e.
      the time required for oxyhemoglobin saturation to drop below 90%). The rate at which
      oxyhemoglobin saturation drops during apnea indicates the efficiency of the maneuver.

      This procedure is strongly recommended for all patients undergoing general anesthesia since
      it lengthens safe laryngoscopy time and grants a wider timeframe to respond to a "cannot
      intubate/cannot oxygenate" (CICO) scenario, a rare yet life threatening situation. It remains
      unclear whether this should be considered mandatory for non-critically ill and non-obese
      patients since their oxygen reserves should suffice for the time required to perform
      endotracheal intubation or regain spontaneous breathing in the event of a CICO scenario.
      Nonetheless, the guidelines for the management of endotracheal intubation, proposed by the
      Difficult Airway Society in 2015 United Kingdom state how it is pivotal to preoxygenate every
      patient before attempting to intubate. Several methods of preoxygenation have been validated
      and compared according to duration of safe apnea time, duration of the procedure, success
      rate (defined as "avoiding manual re-ventilation"), and patient tolerance. The choice between
      these techniques is based on patient characteristics (age, sex, Body Mass Index, American
      Society of Anesthesiologist score, Cormack-Lehane grade and Glasgow Coma Scale), settings
      (e.g., operating room, Intensive Care Unit, emergency situations), equipment, and
      anesthesiologist's preferences. The two standard approaches are six deep breaths in 1 min and
      tidal volume breathing for three to 5 min, both at 100% inspired oxygen via a face mask.

      The main side effect of preoxygenation is absorption atelectasis that occurs when delivering
      100% inspired oxygen. This can be avoided using a lower inspired oxygen concentration (90%),
      positive pressure techniques, and/or recruitment maneuvers post-endotracheal intubation. Due
      to the short duration of the procedure, the production of reactive oxygen species and
      cardiovascular responses are minimal and should not prevent routine preoxygenation.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of preoxygenation use in elective surgery, reporting oxygenations values
time frame: From before induction of general anesthesia until the end of surgical procedure, up to 10 hours
description: Assessment of its efficacy and efficiency in non-critically ill patients, reporting blood oxygen levels just before induction, during induction and maintenance of general anesthesia
measure: Incidence of postoperative pulmonary complications (PPC) related to preoxygenation
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
description: Differentiating PPCs due to preoxygenation from the ones related with patient comorbidity, intraoperative and surgical causes, tube disconnection
measure: Incidence of intraoperative desaturation/hypoxia
time frame: From achieved endotracheal intubation until the end of surgical procedure, up to 10 hours
measure: Incidence of cardiovascular postoperative complications
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of neurological postoperative complications
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of surgical postoperative complications
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of Intensive Care Unit admission and its duration
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of length of in-hospital stay
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michela Tosi, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Benedetta Siroli, MD
role: Principal Investigator
affiliation: University of Parma
last name: Samantha Gorgoglione, MD
role: Principal Investigator
affiliation: University of Parma
last name: Valentina Bellini, MD
role: Principal Investigator
affiliation: University of Parma
last name: Leonardo Fortunati, MD
role: Principal Investigator
affiliation: University of Parma
last name: Andrea Parodi, MD
role: Principal Investigator
affiliation: University of Parma
last name: Andrea Briolini, MD
role: Principal Investigator
affiliation: University of Parma
last name: Elena Giovanna Bignami, Professor of Anesthesiology
phone: +390521033609
email: elenagiovanna.bignami@unipr.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Elena Giovanna Bignami
investigator title: Professor