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/NCT05964309</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-2022-01-446</org_study_id>
      <nct_id>NCT05964309</nct_id>
    </id_info>
    <brief_title>Pre-oxygenation in Sitting Position and Oxygen Reserve Index</brief_title>
    <official_title>Effect of Preoxygenation in Sitting Position on The Oxygen Reserve Index (ORI) Alarm Time as Early Predictor of Impending Hypoxemia During Prolonged Apnea</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imam Abdulrahman Bin Faisal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imam Abdulrahman Bin Faisal University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This prospective, controlled and randomized study aims at comparing the effect of position on&#xD;
        the oxygen reserve index alarm time which is considered as predictor of hypoxemia in&#xD;
        prolonged apnea which might be faced during general anesthesia (GA) in several situations&#xD;
        such as the time from induction of anesthesia till endotracheal intubation.&#xD;
  &#xD;
        participants will be divided into two groups; supine (n=38) and sitting group (n=38) both&#xD;
        group will undergo elective procedures under GA and endotracheal intubation&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction Pre oxygenation with high fraction of inspired oxygen is not only recommended&#xD;
        before anesthesia induction and intubation but also to delay apnea induced hypoxemia in a&#xD;
        variety of airway management and patients with limited oxygen reserve. As well as, to prolong&#xD;
        the duration of apneic oxygenation in some airway interventions. Several methods have been&#xD;
        used to improve the efficiency of pre oxygenation with controversial outcome. One of these&#xD;
        methods is the performance of pre oxygenation in head up position.&#xD;
  &#xD;
        During anesthetic management, pulse oximeter has been considered as valuable noninvasive tool&#xD;
        for monitoring of patient oxygen saturation (SpO2%).&#xD;
  &#xD;
        However, the relationship between the oxygen saturation (SpO2%) and the arterial partial&#xD;
        pressure of oxygen (PaO2) restricts the pulse oximeter monitoring of patient oxygenation due&#xD;
        to the sigmoidal pattern of this relation, as small changes only in SpO2% occur with increase&#xD;
        in arterial oxygen tension above 80 mmHg., Therefore, when oxygen is provided, SpO2 remains&#xD;
        100% over a wide range of PaO2 (&gt;80 mmHg) So It does not reflect the degree of hyperoxia&#xD;
        during oxygen supplementation. On the other hand, when PaO2 is falling, the SpO2 may remain&#xD;
        100% until the PaO2 falls below approximately 80 mm Hg. Thus, it does not predict the onset&#xD;
        of hypoxia in an apneic patient.&#xD;
  &#xD;
        Oxygen reserve index (ORI) is a non-invasive real time non-unit scale between 0.00 and 1.00,&#xD;
        which reflects the level of venous blood oxygen saturation (SvO2). When the patient is&#xD;
        breathing room air ORI is 0.00, With oxygen supplementation, after SpO2 reaches its plateau&#xD;
        of 100%, SvO2 continues rising as PaO2 increasing, and at PaO2 200mmHg usually ORI reaches a&#xD;
        plateau. Hence ORI will serve to indicate PaO2 trends (rising or falling) in the range of&#xD;
        100-200 mmHg), so it will reflect the range of moderate hyperoxia (PaO2 ranging from 100 to&#xD;
        200 mmHg) during oxygen supply and, on the other hand, it will predict impending desaturation&#xD;
        ahead of standard pulse oximetry during safe prolonged apnea technique in surgical patients&#xD;
        at high risk.&#xD;
  &#xD;
        Our study aims at assessment of the effect of pre oxygenation in sitting position on the ORI&#xD;
        warning time for impending de-saturation during safe prolonged apnea techniques.&#xD;
  &#xD;
        Methodology After approval of Institution Review Board and obtaining written informed consent&#xD;
        from all participants, this prospective randomized controlled study will be conducted at King&#xD;
        Fahd University hospital. Written, informed consent will be obtained from 56 illegible&#xD;
        participants scheduled for elective surgery with planned general anesthesia with endotracheal&#xD;
        intubation and invasive blood pressure monitoring (arterial line).&#xD;
  &#xD;
        According to the head position during pre-oxygenation, participants will be randomly&#xD;
        allocated via a computer-generated sequence into two groups; supine group (flat head&#xD;
        position- n=28) and sitting group (90 degree head up position- n=28).&#xD;
  &#xD;
        In the operation room standard monitoring will be applied. ORI sensor (Masimo RD lite) will&#xD;
        be attached to the participant finger.&#xD;
  &#xD;
        After recording the baseline vital signs, pre oxygenation in the three groups will be started&#xD;
        by asking participants to spontaneously breath 100% oxygen via a well fitted face mask for 3&#xD;
        minutes, with rising of end-tidal fraction of oxygen (EtO2) to at least 0.9 and/or ORI to a&#xD;
        plateau value. Rapid sequence induction and intubation using fentanyl, propofol, and&#xD;
        succinylcholine will be performed with the aid of video assisted laryngoscope. The&#xD;
        appropriate position of the endotracheal tube will be confirmed with direct vision and, will&#xD;
        be disconnected from the breathing circuit (to prevent oxygenation while the patient is&#xD;
        apneic) and exposed to the room air until SpO2 decreased to 94% then tube will be connected&#xD;
        to the breathing circuit. Thereafter ventilator setting and anesthetic management will be&#xD;
        according to the decision of the anesthesiologist assigned for patient care at this operative&#xD;
        theater. ORI, SpO2 and PaO2 data were measured at four specific times (1) baseline (2) at the&#xD;
        end of pre-oxygenation (3) at ORI alarm (4) when SpO2 reached 94%. The participant will be&#xD;
        excluded from the study if he has failed pre oxygenation (EtO2 &lt; 0.9 and/or ORI does not&#xD;
        reach a plateau value after 3 min. pre oxygenation.&#xD;
  &#xD;
        Statistical analysis If the difference between the mean ORI alarm time in the sitting group&#xD;
        and the supine group is assumed to be 25 seconds, and a pooled standard deviation of 33&#xD;
        seconds., 28 participants in each group with a total of 56 participant would be an&#xD;
        appropriate sample size to provide a significance of 5% and a power of 80%.&#xD;
  &#xD;
        Data that will be normally distributed will be compared using t-test. Whereas Mann-Whitney&#xD;
        test will be used to compare data with abnormal distribution. Fisher's exact test or Chi&#xD;
        square test will be used to compare categorical data or gender ratio. Probability (p-value)&#xD;
        less than 0.05 will be considered statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Oxygen reserve index (ORI)alarming time</measure>
      <time_frame>baseline, immediately after intubation, ORI warning alarm</time_frame>
      <description>time from intubation till ORI alarm in minutes</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>safe apnea time</measure>
      <time_frame>baseline, immediately after intubation, when SpO2 % drop to 94% assessed in first 10 minutes after induction of general anesthesia</time_frame>
      <description>time from intubation till Oxygen saturation (SpO2) drop to 94%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Oxygen Reserve</measure>
      <time_frame>Baseline, immediately after preoxygenation</time_frame>
      <description>arterial oxygen tension (PaO2) after completion of pre-oxygenation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Hypoxemia</condition>
    <arm_group>
      <arm_group_label>Supine group(Control group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Supine group (flat head position- n=28) during pre-oxygenation patients will be in supine position</description>
    </arm_group>
    <arm_group>
      <arm_group_label>sitting group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sitting position (90 degree head up position- n=28) during pre-oxygenation patients will be in 90 degree head up position</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>supine group</intervention_name>
      <description>after pre-oxygenation in supine position general anesthesia will be established then apnea alarm time will be recorded and compared with other group</description>
      <arm_group_label>Supine group(Control group)</arm_group_label>
      <other_name>control group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sitting group</intervention_name>
      <description>after pre-oxygenation in sitting position general anesthesia will be established then apnea alarm time will be recorded and compared with other group</description>
      <arm_group_label>sitting group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Elective surgery&#xD;
  &#xD;
            -  Age 18-60 years&#xD;
  &#xD;
            -  General Anesthesia with endotracheal intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant cardiac or pulmonary disease.&#xD;
  &#xD;
            -  Anticipated difficult intubation.&#xD;
  &#xD;
            -  History of seizures.&#xD;
  &#xD;
            -  BMI 30kg/m2 or more.&#xD;
  &#xD;
            -  Smoking.&#xD;
  &#xD;
            -  Anemia.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Roshdi M Almetwalli, MD</last_name>
      <phone>009660138966666</phone>
      <phone_ext>1486</phone_ext>
      <email>rmetwalli@iau.edu.sa</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hitham MA Elsayed, MD</last_name>
      <phone>009660138966666</phone>
      <phone_ext>1486</phone_ext>
      <email>Himsayed@iau.edu.sa</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>King Fahd University Hospital</name>
        <address>
          <city>Khobar</city>
          <state>Eastern</state>
          <zip>34445</zip>
          <country>Saudi Arabia</country>
        </address>
      </facility>
      <contact>
        <last_name>Hitham MA Elsyed, MD</last_name>
        <phone>009660138966666</phone>
        <phone_ext>1486</phone_ext>
        <email>HIMelsayed@iau.edu.sa</email>
      </contact>
      <contact_backup>
        <last_name>Roshdi M Almetwalli, MD</last_name>
        <phone>009660138966666</phone>
        <phone_ext>1486</phone_ext>
        <email>rmetwalli@iau.edu.sa</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Imam Abdulrahman Bin Faisal University</investigator_affiliation>
      <investigator_full_name>Roshdi R Almetwalli</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Oxygen reserve index</keyword>
    <keyword>Preoxygenation</keyword>
    <keyword>Hypoxemia</keyword>
    <keyword>Sitting position</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05964309
  org study id: IRB-2022-01-446
  nct id: NCT05964309
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This prospective, controlled and randomized study aims at comparing the effect of position on
        the oxygen reserve index alarm time which is considered as predictor of hypoxemia in
        prolonged apnea which might be faced during general anesthesia (GA) in several situations
        such as the time from induction of anesthesia till endotracheal intubation.
  
        participants will be divided into two groups; supine (n=38) and sitting group (n=38) both
        group will undergo elective procedures under GA and endotracheal intubation
  Introduction Pre oxygenation with high fraction of inspired oxygen is not only recommended
        before anesthesia induction and intubation but also to delay apnea induced hypoxemia in a
        variety of airway management and patients with limited oxygen reserve. As well as, to prolong
        the duration of apneic oxygenation in some airway interventions. Several methods have been
        used to improve the efficiency of pre oxygenation with controversial outcome. One of these
        methods is the performance of pre oxygenation in head up position.
  
        During anesthetic management, pulse oximeter has been considered as valuable noninvasive tool
        for monitoring of patient oxygen saturation (SpO2%).
  
        However, the relationship between the oxygen saturation (SpO2%) and the arterial partial
        pressure of oxygen (PaO2) restricts the pulse oximeter monitoring of patient oxygenation due
        to the sigmoidal pattern of this relation, as small changes only in SpO2% occur with increase
        in arterial oxygen tension above 80 mmHg., Therefore, when oxygen is provided, SpO2 remains
        100% over a wide range of PaO2 (>80 mmHg) So It does not reflect the degree of hyperoxia
        during oxygen supplementation. On the other hand, when PaO2 is falling, the SpO2 may remain
        100% until the PaO2 falls below approximately 80 mm Hg. Thus, it does not predict the onset
        of hypoxia in an apneic patient.
  
        Oxygen reserve index (ORI) is a non-invasive real time non-unit scale between 0.00 and 1.00,
        which reflects the level of venous blood oxygen saturation (SvO2). When the patient is
        breathing room air ORI is 0.00, With oxygen supplementation, after SpO2 reaches its plateau
        of 100%, SvO2 continues rising as PaO2 increasing, and at PaO2 200mmHg usually ORI reaches a
        plateau. Hence ORI will serve to indicate PaO2 trends (rising or falling) in the range of
        100-200 mmHg), so it will reflect the range of moderate hyperoxia (PaO2 ranging from 100 to
        200 mmHg) during oxygen supply and, on the other hand, it will predict impending desaturation
        ahead of standard pulse oximetry during safe prolonged apnea technique in surgical patients
        at high risk.
  
        Our study aims at assessment of the effect of pre oxygenation in sitting position on the ORI
        warning time for impending de-saturation during safe prolonged apnea techniques.
  
        Methodology After approval of Institution Review Board and obtaining written informed consent
        from all participants, this prospective randomized controlled study will be conducted at King
        Fahd University hospital. Written, informed consent will be obtained from 56 illegible
        participants scheduled for elective surgery with planned general anesthesia with endotracheal
        intubation and invasive blood pressure monitoring (arterial line).
  
        According to the head position during pre-oxygenation, participants will be randomly
        allocated via a computer-generated sequence into two groups; supine group (flat head
        position- n=28) and sitting group (90 degree head up position- n=28).
  
        In the operation room standard monitoring will be applied. ORI sensor (Masimo RD lite) will
        be attached to the participant finger.
  
        After recording the baseline vital signs, pre oxygenation in the three groups will be started
        by asking participants to spontaneously breath 100% oxygen via a well fitted face mask for 3
        minutes, with rising of end-tidal fraction of oxygen (EtO2) to at least 0.9 and/or ORI to a
        plateau value. Rapid sequence induction and intubation using fentanyl, propofol, and
        succinylcholine will be performed with the aid of video assisted laryngoscope. The
        appropriate position of the endotracheal tube will be confirmed with direct vision and, will
        be disconnected from the breathing circuit (to prevent oxygenation while the patient is
        apneic) and exposed to the room air until SpO2 decreased to 94% then tube will be connected
        to the breathing circuit. Thereafter ventilator setting and anesthetic management will be
        according to the decision of the anesthesiologist assigned for patient care at this operative
        theater. ORI, SpO2 and PaO2 data were measured at four specific times (1) baseline (2) at the
        end of pre-oxygenation (3) at ORI alarm (4) when SpO2 reached 94%. The participant will be
        excluded from the study if he has failed pre oxygenation (EtO2 < 0.9 and/or ORI does not
        reach a plateau value after 3 min. pre oxygenation.
  
        Statistical analysis If the difference between the mean ORI alarm time in the sitting group
        and the supine group is assumed to be 25 seconds, and a pooled standard deviation of 33
        seconds., 28 participants in each group with a total of 56 participant would be an
        appropriate sample size to provide a significance of 5% and a power of 80%.
  
        Data that will be normally distributed will be compared using t-test. Whereas Mann-Whitney
        test will be used to compare data with abnormal distribution. Fisher's exact test or Chi
        square test will be used to compare categorical data or gender ratio. Probability (p-value)
        less than 0.05 will be considered statistically significant.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Oxygen reserve index (ORI)alarming time
  time frame: baseline, immediately after intubation, ORI warning alarm
  description: time from intubation till ORI alarm in minutes
  measure: safe apnea time
  time frame: baseline, immediately after intubation, when SpO2 % drop to 94% assessed in first 10 minutes after induction of general anesthesia
  description: time from intubation till Oxygen saturation (SpO2) drop to 94%.
  measure: Maximum Oxygen Reserve
  time frame: Baseline, immediately after preoxygenation
  description: arterial oxygen tension (PaO2) after completion of pre-oxygenation
  arm group label: Supine group(Control group)
  arm group type: Experimental
  description: Supine group (flat head position- n=28) during pre-oxygenation patients will be in supine position
  arm group label: sitting group
  arm group type: Experimental
  description: Sitting position (90 degree head up position- n=28) during pre-oxygenation patients will be in 90 degree head up position
  intervention type: Other
  intervention name: supine group
  description: after pre-oxygenation in supine position general anesthesia will be established then apnea alarm time will be recorded and compared with other group
  arm group label: Supine group(Control group)
  other name: control group
  intervention type: Other
  intervention name: sitting group
  description: after pre-oxygenation in sitting position general anesthesia will be established then apnea alarm time will be recorded and compared with other group
  arm group label: sitting group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Roshdi M Almetwalli, MD
  phone: 009660138966666
  phone ext: 1486
  email: rmetwalli@iau.edu.sa
  last name: Hitham MA Elsayed, MD
  phone: 009660138966666
  phone ext: 1486
  email: Himsayed@iau.edu.sa
  facility: 
  contact: 
  contact backup: 
  country: Saudi Arabia
  responsible party type: Principal Investigator
  investigator affiliation: Imam Abdulrahman Bin Faisal University
  investigator full name: Roshdi R Almetwalli
  investigator title: Professor
  mesh term: Hypoxia
  sharing ipd: No