<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/NCT03239678</url>
  </required_header>
  <id_info>
    <org_study_id>2017ZSLYEC-022</org_study_id>
    <nct_id>NCT03239678</nct_id>
  </id_info>
  <brief_title>Safe Time for Apnea After Preoxygenation</brief_title>
  <acronym>STAP</acronym>
  <official_title>Safe Time for Apnea After Preoxygenation With Different Oxygen Concentration During the Induction of General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sixth Affiliated Hospital, Sun Yat-sen University</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>
      The use of 100% oxygen during the induction of general anesthesia is always preferable to&#xD;
      have enough time to secure the airway by endotracheal intubation, because preoxygenation with&#xD;
      a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen&#xD;
      concentration during preoxygenation might prevent the formation of atelectasis. There is&#xD;
      still no clear conclusion about the best oxygen concentration for preoxygenation. Our study&#xD;
      is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen&#xD;
      by the safe time for apnea during the induction of general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We decide to add 3 groups (80%, 60%, and 40% oxygen) in our study to fully evaluate the&#xD;
      safety of preoxygenation with different oxygen concentration.&#xD;
&#xD;
      Zijia Li 2018.3.2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safe time for apnea</measure>
    <time_frame>10 min</time_frame>
    <description>Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time needed for endotracheal intubation</measure>
    <time_frame>1 min</time_frame>
    <description>Time from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Anesthesia, General</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100% Oxygen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30% Oxygen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21% Oxygen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40% Oxygen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60% Oxygen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80% Oxygen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100% Oxygen</intervention_name>
    <description>Conventional preoxygenation with 100% oxygen</description>
    <arm_group_label>group A</arm_group_label>
    <other_name>100% O2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>30% Oxygen</intervention_name>
    <description>preoxygenation with 30% oxygen</description>
    <arm_group_label>group B</arm_group_label>
    <other_name>30% O2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>21% Oxygen</intervention_name>
    <description>preoxygenation with 21% oxygen</description>
    <arm_group_label>group C</arm_group_label>
    <other_name>21% O2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40% Oxygen</intervention_name>
    <description>preoxygenation with 40% oxygen</description>
    <arm_group_label>group D</arm_group_label>
    <other_name>40% O2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>60% Oxygen</intervention_name>
    <description>preoxygenation with 60% oxygen</description>
    <arm_group_label>group E</arm_group_label>
    <other_name>60% O2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>80% Oxygen</intervention_name>
    <description>preoxygenation with 80% oxygen</description>
    <arm_group_label>group F</arm_group_label>
    <other_name>80% O2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nonsmoking patients aged 18 years to 60 years&#xD;
&#xD;
          -  Undergoing general anesthesia for elective surgery&#xD;
&#xD;
          -  Pulse oxygen saturation ≥95% when breathing air quietly in bed&#xD;
&#xD;
          -  American Society of Anesthesiologists(ASA) physical status class I-II&#xD;
&#xD;
          -  Informed consent can be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A suspected difficult airway&#xD;
&#xD;
          -  Be allergic to midazolam, propofol , fentanyl or Cisatracurium&#xD;
&#xD;
          -  Severe disease of respiratory system or cardiovascular system,or obstruction of the&#xD;
             digestive tract&#xD;
&#xD;
          -  Oxygen reserve is suspected low,or patient who does not tolerate hypoxemia well&#xD;
&#xD;
          -  A history of mental disorder or patient who can not collaborate well&#xD;
&#xD;
          -  Body mass index more than 30 kg/㎡&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanqing Jin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zijia Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia ,the Sixth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Lundquist H, Hedenstierna G, Strandberg A, Tokics L, Brismar B. CT-assessment of dependent lung densities in man during general anaesthesia. Acta Radiol. 1995 Nov;36(6):626-32.</citation>
    <PMID>8519574</PMID>
  </reference>
  <reference>
    <citation>Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3.</citation>
    <PMID>7760608</PMID>
  </reference>
  <reference>
    <citation>Edmark L, Kostova-Aherdan K, Enlund M, Hedenstierna G. Optimal oxygen concentration during induction of general anesthesia. Anesthesiology. 2003 Jan;98(1):28-33. doi: 10.1097/00000542-200301000-00008.</citation>
    <PMID>12502975</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Zijia Li</investigator_full_name>
    <investigator_title>Principal Investigator, Department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University</investigator_title>
  </responsible_party>
  <keyword>Preoxygenation</keyword>
  <keyword>Oxygen Concentration</keyword>
  <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/NCT03239678
org study id: 2017ZSLYEC-022
nct id: NCT03239678
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The use of 100% oxygen during the induction of general anesthesia is always preferable to
      have enough time to secure the airway by endotracheal intubation, because preoxygenation with
      a low oxygen concentration may reduce the safe time for apnea. However, using a low oxygen
      concentration during preoxygenation might prevent the formation of atelectasis. There is
      still no clear conclusion about the best oxygen concentration for preoxygenation. Our study
      is designed to evaluate the safety of preoxygenation with 80%, 60%, 40%, 30% and 21% oxygen
      by the safe time for apnea during the induction of general anesthesia.
We decide to add 3 groups (80%, 60%, and 40% oxygen) in our study to fully evaluate the
      safety of preoxygenation with different oxygen concentration.

      Zijia Li 2018.3.2
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Safe time for apnea
time frame: 10 min
description: Time when peripheral oxygen saturation (SpO2) is ≥ 90% after preoxygenation.
measure: Time needed for endotracheal intubation
time frame: 1 min
description: Time from when the laryngoscope blade first passes the lips to when the cuff of tracheal tube is inflated.
arm group label: group A
arm group type: Active Comparator
description: 100% Oxygen
arm group label: group B
arm group type: Experimental
description: 30% Oxygen.
arm group label: group C
arm group type: Experimental
description: 21% Oxygen
arm group label: group D
arm group type: Experimental
description: 40% Oxygen
arm group label: group E
arm group type: Experimental
description: 60% Oxygen
arm group label: group F
arm group type: Experimental
description: 80% Oxygen
intervention type: Drug
intervention name: 100% Oxygen
description: Conventional preoxygenation with 100% oxygen
arm group label: group A
other name: 100% O2
intervention type: Drug
intervention name: 30% Oxygen
description: preoxygenation with 30% oxygen
arm group label: group B
other name: 30% O2
intervention type: Drug
intervention name: 21% Oxygen
description: preoxygenation with 21% oxygen
arm group label: group C
other name: 21% O2
intervention type: Drug
intervention name: 40% Oxygen
description: preoxygenation with 40% oxygen
arm group label: group D
other name: 40% O2
intervention type: Drug
intervention name: 60% Oxygen
description: preoxygenation with 60% oxygen
arm group label: group E
other name: 60% O2
intervention type: Drug
intervention name: 80% Oxygen
description: preoxygenation with 80% oxygen
arm group label: group F
other name: 80% O2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sanqing Jin, MD
role: Principal Investigator
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
last name: Zijia Li
role: Principal Investigator
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
facility: 
country: China
citation: Lundquist H, Hedenstierna G, Strandberg A, Tokics L, Brismar B. CT-assessment of dependent lung densities in man during general anaesthesia. Acta Radiol. 1995 Nov;36(6):626-32.
PMID: 8519574
citation: Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3.
PMID: 7760608
citation: Edmark L, Kostova-Aherdan K, Enlund M, Hedenstierna G. Optimal oxygen concentration during induction of general anesthesia. Anesthesiology. 2003 Jan;98(1):28-33. doi: 10.1097/00000542-200301000-00008.
PMID: 12502975
responsible party type: Principal Investigator
investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
investigator full name: Zijia Li
investigator title: Principal Investigator, Department of anesthesiology, Sixth Affiliated Hospital, Sun Yat-sen University
sharing ipd: Undecided