<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/NCT03024723</url>
  </required_header>
  <id_info>
    <org_study_id>2013-P-000095/1</org_study_id>
    <nct_id>NCT03024723</nct_id>
  </id_info>
  <brief_title>Nasal Continuous Positive Airway Pressure and Airway Patency in Obese Patient</brief_title>
  <official_title>Comparison of Upper Airway Patency Using Continuous Positive Airway Pressure Ventilation Via a Nasal Mask With a Face Mask During Induction of Anesthesia on Obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities&#xD;
      with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal&#xD;
      continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway&#xD;
      patent with near 100% success in patients with OSA. Obesity is a major risk factors for&#xD;
      obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia.&#xD;
      The investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients&#xD;
      under anesthesia. The investigators propose to test this hypothesis and determine the&#xD;
      efficacy of nCPAP on maintaining airway patency in obese patients who require general&#xD;
      anesthesia compared with CPAP administering face mask.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upper airway obstruction (UAO) is an unpredictable and frequently occurring complication&#xD;
      during induction of general anesthesia. Since obese patients are more vulnerable to develop&#xD;
      airway obstruction either during sleep1 or under anesthesia, and the segment of obese&#xD;
      individuals in the entire population keep growing, difficult airway management under&#xD;
      anesthesia becomes even more challenging than ever. The most serious event related to&#xD;
      difficult airway management under anesthesia is &quot;cannot intubate, cannot ventilate&quot;.&#xD;
&#xD;
      The mechanism of UAO during anesthesia has not been well understood. Obese patients are a&#xD;
      high-risk group for perioperative airway catastrophe and prone to develop progressively&#xD;
      narrower pharyngeal airways due to an increase of soft tissue volume surrounding the&#xD;
      pharyngeal airway. The mechanism of UAO during anesthesia shares many similarities with the&#xD;
      upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal continuous&#xD;
      positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway patent with near&#xD;
      100% success in patients with OSA. Obesity is a major risk factors for obstructive sleep&#xD;
      apnea and obese patients have a higher prevalence of UAO during anesthesia. Therefore, the&#xD;
      investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients&#xD;
      under anesthesia. The investigators propose to test this hypothesis and determine the&#xD;
      efficacy of nCPAP on maintaining airway patency in obese patients who require general&#xD;
      anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>expired tidal volume</measure>
    <time_frame>3 minutes</time_frame>
    <description>This group of the subjects will start with nasal mask or face mask CPAP ventilation. The anesthesia care team does whatever they routinely do, including adjusting the patient's position (as to reverse Trendelenburg position), pre-oxygenation, pre-medication, as usual with intravenous anesthetics and analgesics. When the patient is apneic, CPAP ventilation will be initiated with pressure support mode at PIP 25 cmH2O, ventilation rate 10 BPM, PEEP 10 cmH2O and slope 1 second for 1 min. If ventilation is effective in one of the first three breaths, the ventilation will continue for 1 min. If effective ventilation cannot be produced in any of the first three breaths, the study will be terminated and routine care will be provided.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>expired tidal volume/Area under the Curve of the pressure trace</measure>
    <time_frame>3 minutes</time_frame>
    <description>The area under the airway pressure curve (AUC) defined as the area from the baseline pressure to the peak pressure during inspiration was calculated for evaluating pressure applied during inspiration. The AUC is a reflection of the change in mean airway pressure.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>FmCPAP</arm_group_label>
    <description>CPAP ventilation administered via face mask</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nasal mask CPAP</intervention_name>
    <description>CPAP and ventilation administered via nasal mask</description>
    <arm_group_label>FmCPAP</arm_group_label>
    <other_name>nCPAP</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult obese patient undergoing general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Body Mass Index:30 to 50 kg/ m2, Age: 18-65 years old ASA physical status classification:&#xD;
        I-III Requiring general anesthesia for elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with major cardiovascular disease, respiratory disease, cerebral vascular&#xD;
             disease or American Society of Anesthesiologists physical status class IV or greater.&#xD;
&#xD;
          2. Abnormal vital signs on the day of admission for surgery [heart rate (HR, &gt;100 bpm or&#xD;
             &lt;40 bpm), blood pressure (BP, &gt;180/100 mmHg or &lt;90/60 mmHg), room air transcutaneous&#xD;
             oxyhemoglobin saturation (SPO2) &lt;96%] that are not correctable with his or her routine&#xD;
             medication or commonly used pre-operative medication.&#xD;
&#xD;
          3. Having claustrophobia and not able to tolerate the mask.&#xD;
&#xD;
          4. Any person with an anticipated difficult airway or those with a history of difficult&#xD;
             airway. This will include subjects who require or may require either a fiberoptic&#xD;
             intubation or intubation while awake.&#xD;
&#xD;
          5. Gastric-esophageal reflex disease that is refractory to treatment or a full stomach.&#xD;
&#xD;
          6. The subject has been in bed for more than 24 hours.&#xD;
&#xD;
          7. Neurological symptoms associated with neck extension, a neurological deficit from a&#xD;
             previous stroke or spinal cord injury, a recent stroke or transient ischemic attack&#xD;
             (TIA) within 2 weeks.&#xD;
&#xD;
          8. Pregnant women and women less than one month post-partum. Ruling out pregnancy will be&#xD;
             conducted by careful history and physical examination as performed routinely prior to&#xD;
             surgery. If the history is believed to be unreliable, the patient will be excluded&#xD;
             unless a pregnancy test is performed and the result of the test is negative.&#xD;
&#xD;
          9. Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os)&#xD;
             guidelines.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yandong Jiang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>March 13, 2013</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>March 17, 2017</last_update_submitted>
  <last_update_submitted_qc>March 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Yandong Jiang</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Obese patient</keyword>
  <keyword>nasal CPAP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03024723
org study id: 2013-P-000095/1
nct id: NCT03024723
lead sponsor: 
has dmc: Yes
The mechanism of Upper airway obstruction (UAO) during anesthesia shares many similarities
      with the upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal
      continuous positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway
      patent with near 100% success in patients with OSA. Obesity is a major risk factors for
      obstructive sleep apnea and obese patients have a higher prevalence of UAO during anesthesia.
      The investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients
      under anesthesia. The investigators propose to test this hypothesis and determine the
      efficacy of nCPAP on maintaining airway patency in obese patients who require general
      anesthesia compared with CPAP administering face mask.
Upper airway obstruction (UAO) is an unpredictable and frequently occurring complication
      during induction of general anesthesia. Since obese patients are more vulnerable to develop
      airway obstruction either during sleep1 or under anesthesia, and the segment of obese
      individuals in the entire population keep growing, difficult airway management under
      anesthesia becomes even more challenging than ever. The most serious event related to
      difficult airway management under anesthesia is "cannot intubate, cannot ventilate".

      The mechanism of UAO during anesthesia has not been well understood. Obese patients are a
      high-risk group for perioperative airway catastrophe and prone to develop progressively
      narrower pharyngeal airways due to an increase of soft tissue volume surrounding the
      pharyngeal airway. The mechanism of UAO during anesthesia shares many similarities with the
      upper airway obstruction observed during obstructive sleep apnea (OSA). Nasal continuous
      positive airway pressure (nCPAP) via nasal mask (NM) can maintain the airway patent with near
      100% success in patients with OSA. Obesity is a major risk factors for obstructive sleep
      apnea and obese patients have a higher prevalence of UAO during anesthesia. Therefore, the
      investigators hypotheses that nCPAP should eliminate airway obstruction in obese patients
      under anesthesia. The investigators propose to test this hypothesis and determine the
      efficacy of nCPAP on maintaining airway patency in obese patients who require general
      anesthesia.
observational model: Cohort
time perspective: Prospective
measure: expired tidal volume
time frame: 3 minutes
description: This group of the subjects will start with nasal mask or face mask CPAP ventilation. The anesthesia care team does whatever they routinely do, including adjusting the patient's position (as to reverse Trendelenburg position), pre-oxygenation, pre-medication, as usual with intravenous anesthetics and analgesics. When the patient is apneic, CPAP ventilation will be initiated with pressure support mode at PIP 25 cmH2O, ventilation rate 10 BPM, PEEP 10 cmH2O and slope 1 second for 1 min. If ventilation is effective in one of the first three breaths, the ventilation will continue for 1 min. If effective ventilation cannot be produced in any of the first three breaths, the study will be terminated and routine care will be provided.
measure: expired tidal volume/Area under the Curve of the pressure trace
time frame: 3 minutes
description: The area under the airway pressure curve (AUC) defined as the area from the baseline pressure to the peak pressure during inspiration was calculated for evaluating pressure applied during inspiration. The AUC is a reflection of the change in mean airway pressure.
arm group label: FmCPAP
description: CPAP ventilation administered via face mask
intervention type: Device
intervention name: nasal mask CPAP
description: CPAP and ventilation administered via nasal mask
arm group label: FmCPAP
other name: nCPAP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yandong Jiang, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Yandong Jiang
investigator title: Dr.
mesh term: Obesity