<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/NCT03271827</url>
  </required_header>
  <id_info>
    <org_study_id>SP15/134</org_study_id>
    <nct_id>NCT03271827</nct_id>
  </id_info>
  <brief_title>Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia.</brief_title>
  <official_title>Apnoeic Oxygenation by Nasal Cannula During Airway Management in Children Undergoing General Anaesthesia: A Pilot Randomised Controlled Trial&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Abdullah International Medical Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</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>
      Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction&#xD;
      of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is&#xD;
      effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in&#xD;
      the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim&#xD;
      of this study was to investigate the effectiveness of apnoeic oxygenation during airway&#xD;
      management in children.&#xD;
&#xD;
      This was a pilot randomised controlled trial. Patients were randomised to either receive&#xD;
      apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome&#xD;
      was the duration of safe apnoea, defined as a composite of the time to first event, either&#xD;
      time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2&#xD;
      observed during airway management. Secondary outcomes were number of patients whose SpO2&#xD;
      dropped below 95% and number of patients whose SpO2 dropped below 92%.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first event</measure>
    <time_frame>Estimated: 10 seconds to 3 minutes</time_frame>
    <description>Time to first event: either time for SpO2 to fall to 92% or time to successfully secure the airway as usual practice without allowing desaturation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The lowest SpO2 observed during airway management</measure>
    <time_frame>Estimated: 10 seconds to 3 minutes</time_frame>
    <description>The lowest SpO2 observed during airway management</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients whose SpO2 dropped below 95%</measure>
    <time_frame>Estimated: 10 seconds to 3 minutes</time_frame>
    <description>Number of patients whose SpO2 dropped below 95%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients whose SpO2 dropped below 92%</measure>
    <time_frame>Estimated: 10 seconds to 3 minutes</time_frame>
    <description>Number of patients whose SpO2 dropped below 92%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Apnoeic Oxygenation</condition>
  <arm_group>
    <arm_group_label>Apnoeic oxygenation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard airway management + 3 L/min of oxygen by nasal cannula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard airway management</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apnoeic oxygenation</intervention_name>
    <description>3 L/min of oxygen by nasal cannula during as apnoeic oxygenation during airway management.</description>
    <arm_group_label>Apnoeic oxygenation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were included who were scheduled for elective surgery under general&#xD;
             anaesthesia.&#xD;
&#xD;
          -  Age: one eight years old.&#xD;
&#xD;
          -  ASA I and II only.&#xD;
&#xD;
          -  Patients with normal cardiorespiratory function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children undergoing dental surgeries in which nasal intubation is needed.&#xD;
&#xD;
          -  Patients who suffered from quick drops in oxygen saturation more rapidly than healthy&#xD;
             children due to different reasons such as: respiratory and pulmonary diseases, active&#xD;
             or recent upper respiratory tract infection, syndromes with cardiopulmonary&#xD;
             pathologies, cardiac anomalies, anaemia, depressed respiratory effort,&#xD;
             ventilation/perfusion imbalance, Obstructive Sleep Apnoea (OSA), and airway&#xD;
             obstruction.&#xD;
&#xD;
          -  Patients reported with nasal obstruction.&#xD;
&#xD;
          -  Patients with grades of laryngoscopic view (Cormack Lahane) greater than II, which&#xD;
             indicates upper airway obstruction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lafi Olayan, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdullah International Research Center (KAIMRC)</affiliation>
  </overall_official>
  <reference>
    <citation>Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.</citation>
    <PMID>22050948</PMID>
  </reference>
  <reference>
    <citation>Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.</citation>
    <PMID>17635423</PMID>
  </reference>
  <reference>
    <citation>Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.</citation>
    <PMID>20400000</PMID>
  </reference>
  <reference>
    <citation>Wimalasena Y, Burns B, Reid C, Ware S, Habig K. Apneic oxygenation was associated with decreased desaturation rates during rapid sequence intubation by an Australian helicopter emergency medicine service. Ann Emerg Med. 2015 Apr;65(4):371-6. doi: 10.1016/j.annemergmed.2014.11.014. Epub 2014 Dec 20.</citation>
    <PMID>25536868</PMID>
  </reference>
  <reference>
    <citation>Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.</citation>
    <PMID>16674614</PMID>
  </reference>
  <reference>
    <citation>Hardman JG, Wills JS, Aitkenhead AR. Factors determining the onset and course of hypoxemia during apnea: an investigation using physiological modelling. Anesth Analg. 2000 Mar;90(3):619-24. doi: 10.1097/00000539-200003000-00022.</citation>
    <PMID>10702447</PMID>
  </reference>
  <reference>
    <citation>Hardman JG, Wills JS. The development of hypoxaemia during apnoea in children: a computational modelling investigation. Br J Anaesth. 2006 Oct;97(4):564-70. doi: 10.1093/bja/ael178. Epub 2006 Jul 27.</citation>
    <PMID>16873387</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Birmingham</investigator_affiliation>
    <investigator_full_name>Lafi Olayan</investigator_full_name>
    <investigator_title>Research fellow</investigator_title>
  </responsible_party>
  <keyword>Apnoeic oxygenation</keyword>
  <keyword>Airway management</keyword>
  <keyword>Oxygen insufflation</keyword>
  <keyword>Paediatric general anaesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03271827
org study id: SP15/134
nct id: NCT03271827
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Airway management is a core clinical skill in anaesthesia. Pre-oxygenation prior to induction
      of anaesthesia is standard practice to prevent desaturation. Apnoeic oxygenation in adults is
      effective and prolongs the time to desaturation. The effectiveness of apnoeic oxygenation in
      the adult is well document, however evidence in the paediatric is lacking. Therefore, the aim
      of this study was to investigate the effectiveness of apnoeic oxygenation during airway
      management in children.

      This was a pilot randomised controlled trial. Patients were randomised to either receive
      apnoeic oxygenation or standard care during the induction of anaesthesia. The primary outcome
      was the duration of safe apnoea, defined as a composite of the time to first event, either
      time for SpO2 to drop to 92% or time to successfully secure the airway, and the lowest SpO2
      observed during airway management. Secondary outcomes were number of patients whose SpO2
      dropped below 95% and number of patients whose SpO2 dropped below 92%.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Time to first event
time frame: Estimated: 10 seconds to 3 minutes
description: Time to first event: either time for SpO2 to fall to 92% or time to successfully secure the airway as usual practice without allowing desaturation
measure: The lowest SpO2 observed during airway management
time frame: Estimated: 10 seconds to 3 minutes
description: The lowest SpO2 observed during airway management
measure: Number of patients whose SpO2 dropped below 95%
time frame: Estimated: 10 seconds to 3 minutes
description: Number of patients whose SpO2 dropped below 95%
measure: Number of patients whose SpO2 dropped below 92%
time frame: Estimated: 10 seconds to 3 minutes
description: Number of patients whose SpO2 dropped below 92%
arm group label: Apnoeic oxygenation group
arm group type: Experimental
description: Standard airway management + 3 L/min of oxygen by nasal cannula
arm group label: Standard care group
arm group type: No Intervention
description: Standard airway management
intervention type: Device
intervention name: Apnoeic oxygenation
description: 3 L/min of oxygen by nasal cannula during as apnoeic oxygenation during airway management.
arm group label: Apnoeic oxygenation group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: No
last name: Lafi Olayan, MSc
role: Principal Investigator
affiliation: King Abdullah International Research Center (KAIMRC)
citation: Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PMID: 22050948
citation: Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.
PMID: 17635423
citation: Ramachandran SK, Cosnowski A, Shanks A, Turner CR. Apneic oxygenation during prolonged laryngoscopy in obese patients: a randomized, controlled trial of nasal oxygen administration. J Clin Anesth. 2010 May;22(3):164-8. doi: 10.1016/j.jclinane.2009.05.006.
PMID: 20400000
citation: Wimalasena Y, Burns B, Reid C, Ware S, Habig K. Apneic oxygenation was associated with decreased desaturation rates during rapid sequence intubation by an Australian helicopter emergency medicine service. Ann Emerg Med. 2015 Apr;65(4):371-6. doi: 10.1016/j.annemergmed.2014.11.014. Epub 2014 Dec 20.
PMID: 25536868
citation: Taha SK, Siddik-Sayyid SM, El-Khatib MF, Dagher CM, Hakki MA, Baraka AS. Nasopharyngeal oxygen insufflation following pre-oxygenation using the four deep breath technique. Anaesthesia. 2006 May;61(5):427-30. doi: 10.1111/j.1365-2044.2006.04610.x.
PMID: 16674614
citation: Hardman JG, Wills JS, Aitkenhead AR. Factors determining the onset and course of hypoxemia during apnea: an investigation using physiological modelling. Anesth Analg. 2000 Mar;90(3):619-24. doi: 10.1097/00000539-200003000-00022.
PMID: 10702447
citation: Hardman JG, Wills JS. The development of hypoxaemia during apnoea in children: a computational modelling investigation. Br J Anaesth. 2006 Oct;97(4):564-70. doi: 10.1093/bja/ael178. Epub 2006 Jul 27.
PMID: 16873387
responsible party type: Principal Investigator
investigator affiliation: University of Birmingham
investigator full name: Lafi Olayan
investigator title: Research fellow
mesh term: Apnea
sharing ipd: No