<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/NCT04438798</url>
  </required_header>
  <id_info>
    <org_study_id>0304665</org_study_id>
    <nct_id>NCT04438798</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section</brief_title>
  <official_title>A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen&#xD;
      therapy for preoxygenation and oxygen supplementation during apnoea has shown promising&#xD;
      results&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to&#xD;
      safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation&#xD;
      and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measure the time of safe apnea</measure>
    <time_frame>10 minutes after induction</time_frame>
    <description>The apnea time will start from the onset of cessation of breathing as evidenced by a flat line in the capnogram with the absence of chest movements</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hypoxic Brain Injury</condition>
  <condition>Maternal Death</condition>
  <arm_group>
    <arm_group_label>face mask group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>THRIVE group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>F Group</intervention_name>
    <description>In Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.</description>
    <arm_group_label>face mask group</arm_group_label>
    <other_name>face mask</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>H Group</intervention_name>
    <description>In Group H, high-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.</description>
    <arm_group_label>THRIVE group</arm_group_label>
    <other_name>THRIVE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant females&#xD;
&#xD;
          -  Of American Society of Anesthesiologists (ASA) physical Status I and II&#xD;
&#xD;
          -  For elective cesarean section under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with room air saturation of &lt;98%&#xD;
&#xD;
          -  anticipated difficult airway&#xD;
&#xD;
          -  anticipated obstetric risk factor or precious baby&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
          -  thyrotoxicosis&#xD;
&#xD;
          -  pheochromocytoma&#xD;
&#xD;
          -  hyperkalaemia&#xD;
&#xD;
          -  significant cardiac illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rehab A. Abd Elaziz, Ass.Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
    <phone>01001073703</phone>
    <phone_ext>020</phone_ext>
    <email>trcium2002@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rehab Abd Elraof Abd Elaziz</name>
      <address>
        <city>Alexandria</city>
        <zip>000000</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
      <phone>01001073703</phone>
      <phone_ext>020</phone_ext>
      <email>trcium2002@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.</citation>
    <PMID>28035669</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>rehab zayed</investigator_full_name>
    <investigator_title>Assisstant Professor of Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Maternal Death</mesh_term>
  </condition_browse>
  <!-- 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/NCT04438798
org study id: 0304665
nct id: NCT04438798
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen
      therapy for preoxygenation and oxygen supplementation during apnoea has shown promising
      results
Eeffective preoxygenation followed by apnoeic oxygenation enables anaesthesiologists to
      safely prolong the apnoea time which is the time (seconds) of apnea following preoxygenation
      and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: measure the time of safe apnea
time frame: 10 minutes after induction
description: The apnea time will start from the onset of cessation of breathing as evidenced by a flat line in the capnogram with the absence of chest movements
arm group label: face mask group
arm group type: Placebo Comparator
description: Pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.
arm group label: THRIVE group
arm group type: Active Comparator
description: High-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.
intervention type: Other
intervention name: F Group
description: In Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.
arm group label: face mask group
other name: face mask
intervention type: Other
intervention name: H Group
description: In Group H, high-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.
arm group label: THRIVE group
other name: THRIVE
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Rehab A. Abd Elaziz, Ass.Prof.
role: Principal Investigator
affiliation: Alexandria University
last name: Rehab A. Abd Elaziz, Ass. Prof.
phone: 01001073703
phone ext: 020
email: trcium2002@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
PMID: 28035669
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: rehab zayed
investigator title: Assisstant Professor of Anesthesia
mesh term: Brain Injuries
mesh term: Maternal Death