<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/NCT03009877</url>
  </required_header>
  <id_info>
    <org_study_id>2016-7360</org_study_id>
    <nct_id>NCT03009877</nct_id>
  </id_info>
  <brief_title>Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask</brief_title>
  <official_title>Preoxygenation With Optiflow™, a High Flow Nasal Cannula (HFNC), is Superior to Preoxygenation With Facemask in Morbidly Obese Patients Undergoing General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient&#xD;
      population. This study will examine whether Optiflow can do this, and compare the&#xD;
      pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of high flow nasal cannula (HFNC) originated in neonatal care, and has become&#xD;
      widespread in its application for patients that are high risk for hypoxemia, both in critical&#xD;
      care and emergency settings. Therefore, high flow nasal oxygenation continues to be studied&#xD;
      in airway management for preoxygenation, as well as maintenance of oxygenation in airway&#xD;
      procedures. Optiflow™, a humidified high flow nasal cannula, has already been shown to be&#xD;
      useful in preventing desaturation during intubation in ICU patients versus the&#xD;
      non-rebreathing mask, in addition to, prolonging safe apnea time in patients with potential&#xD;
      difficult airways. Additionally, preoxygenation with HFNC prior to intubation of patients in&#xD;
      hypoxemic respiratory failure has also been shown to decrease desaturation during apnea&#xD;
      compared to preoxygenation with traditional bag valve mask. The morbidly obese patient&#xD;
      presents a separate group of challenges to the anesthesiologist in regards to mask&#xD;
      ventilation and intubation. Obesity (along with other factors) has been shown to contribute&#xD;
      to difficulty with mask ventilation. Obese patients have altered respiratory physiology,&#xD;
      including decreased functional residual capacity, increased oxygen consumption and lower&#xD;
      tidal volumes, as compared to the non-obese patient. These factors contribute to obese&#xD;
      patients potentially having a shorter apnea time before desaturating during induction of&#xD;
      general anesthesia, as compared to the non-obese patient. Weight is inversely correlated with&#xD;
      safe apnea time. Optiflow™ may provide an opportunity to prolong apnea time in the morbidly&#xD;
      obese patient population. If demonstrated to be efficacious as a method for preoxygenation&#xD;
      and prolongation of apneic time, this could provide a safer environment for intubation in&#xD;
      this particular patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    withdrawn prior to IRB approval&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to desaturation</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>Intraoperatively, apneic time will be record from the time of administration of the muscle relaxant. The time until the first desaturation will be recorded. The maximum time of measurement will be 10 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time until hypercarbia &gt; 65 mmHg</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>The time until hypercarbia to more than 65 mmHg will be measured from the time of administration of the muscle relaxant. The time until transcutaneous CO2 is &gt; 65 mmHg will be recorded, unless 10 minutes is reached before that level is reached.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>Assessment of accurate correlation between transcutaneous CO2 monitoring, end tidal CO2, and/or PaCO2 will be performed up to 10 minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optiflow F&amp;P 850™ System</intervention_name>
    <description>Optiflow™ (Fisher &amp; Paykel Healthcare Limited, East Tamaki, Auckland-New Zealand) offers the ability to comfortably deliver a complete range of oxygen concentrations and flows to extend the traditional boundaries of oxygen therapy.&#xD;
This will be placed on the patient immediately upon entering the operating room for 5 minutes, at 50 liters per minute then increased to 70 liters per minute after induction.</description>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <other_name>High flow nasal cannula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>facemask</intervention_name>
    <description>We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.</description>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
    <other_name>face mask</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Rocuronium will be administered after the ability to mask ventilate is determined.</description>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.</description>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.</description>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.</description>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
    <other_name>Versed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>C-MAC Premium Video Intubation Platform-KARL STORZ</intervention_name>
    <description>After patient is induced, the 5.5mm flexible intubation video scope (C-MAC Premium Video Intubation Platform-KARL STORZ) will then be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope (3 or 4 blade based on anesthesiologist's discretion).</description>
    <arm_group_label>Preoxygenation via hi flow nasal cannula</arm_group_label>
    <arm_group_label>Preoxygenation with face mask</arm_group_label>
    <other_name>videolaryngoscope and optical fiberoptic bronchoscope</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (≥ 18 years old) undergoing elective surgery requiring general&#xD;
             anesthesia&#xD;
&#xD;
          -  BMI &gt; 40 kg/m2&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) Physical Status II-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic hypoxemia (SpO2 &lt;94% on room air or on home oxygen)&#xD;
&#xD;
          -  Acute respiratory failure&#xD;
&#xD;
          -  Coronary artery disease and/or congestive heart failure&#xD;
&#xD;
          -  Moderate-Severe pulmonary hypertension and/or RV dysfunction&#xD;
&#xD;
          -  Full stomach (recently eaten)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)&#xD;
&#xD;
          -  Respiratory tract pathology&#xD;
&#xD;
          -  Facial Abnormality&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) Physical Status IV-V&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Osborn, MD</last_name>
    <role>Study Director</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <reference>
    <citation>Locke RG, Wolfson MR, Shaffer TH, Rubenstein SD, Greenspan JS. Inadvertent administration of positive end-distending pressure during nasal cannula flow. Pediatrics. 1993 Jan;91(1):135-8.</citation>
    <PMID>8416477</PMID>
  </reference>
  <reference>
    <citation>Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.</citation>
    <PMID>25981908</PMID>
  </reference>
  <reference>
    <citation>Hayes-Bradley C, Lewis A, Burns B, Miller M. Efficacy of Nasal Cannula Oxygen as a Preoxygenation Adjunct in Emergency Airway Management. Ann Emerg Med. 2016 Aug;68(2):174-80. doi: 10.1016/j.annemergmed.2015.11.012. Epub 2015 Dec 31.</citation>
    <PMID>26747218</PMID>
  </reference>
  <reference>
    <citation>Badiger S, John M, Fearnley RA, Ahmad I. Optimizing oxygenation and intubation conditions during awake fibre-optic intubation using a high-flow nasal oxygen-delivery system. Br J Anaesth. 2015 Oct;115(4):629-32. doi: 10.1093/bja/aev262. Epub 2015 Aug 7.</citation>
    <PMID>26253608</PMID>
  </reference>
  <reference>
    <citation>Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.</citation>
    <PMID>25529351</PMID>
  </reference>
  <reference>
    <citation>Miyagi K, Haranaga S, Higa F, Tateyama M, Fujita J. Implementation of bronchoalveolar lavage using a high-flow nasal cannula in five cases of acute respiratory failure. Respir Investig. 2014 Sep;52(5):310-4. doi: 10.1016/j.resinv.2014.06.006. Epub 2014 Jul 25.</citation>
    <PMID>25169847</PMID>
  </reference>
  <reference>
    <citation>Gottschalk A, Mirza N, Weinstein GS, Edwards MW. Capnography during jet ventilation for laryngoscopy. Anesth Analg. 1997 Jul;85(1):155-9. doi: 10.1097/00000539-199707000-00028.</citation>
    <PMID>9212140</PMID>
  </reference>
  <reference>
    <citation>Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.</citation>
    <PMID>25866645</PMID>
  </reference>
  <reference>
    <citation>Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.</citation>
    <PMID>25388828</PMID>
  </reference>
  <reference>
    <citation>Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.</citation>
    <PMID>25003980</PMID>
  </reference>
  <reference>
    <citation>Aceto P, Perilli V, Modesti C, Ciocchetti P, Vitale F, Sollazzi L. Airway management in obese patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):809-15. doi: 10.1016/j.soard.2013.04.013. Epub 2013 May 6.</citation>
    <PMID>23810609</PMID>
  </reference>
  <reference>
    <citation>Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.</citation>
    <PMID>23836064</PMID>
  </reference>
  <reference>
    <citation>Sinha A, Jayaraman L, Punhani D. ProSeal LMA increases safe apnea period in morbidly obese patients undergoing surgery under general anesthesia. Obes Surg. 2013 Apr;23(4):580-4. doi: 10.1007/s11695-012-0833-7.</citation>
    <PMID>23361469</PMID>
  </reference>
  <reference>
    <citation>Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg. 1991 Jan;72(1):89-93. doi: 10.1213/00000539-199101000-00016.</citation>
    <PMID>1984382</PMID>
  </reference>
  <reference>
    <citation>Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70. No abstract available.</citation>
    <PMID>3578856</PMID>
  </reference>
  <reference>
    <citation>Tang L, Li S, Huang S, Ma H, Wang Z. Desaturation following rapid sequence induction using succinylcholine vs. rocuronium in overweight patients. Acta Anaesthesiol Scand. 2011 Feb;55(2):203-8. doi: 10.1111/j.1399-6576.2010.02365.x.</citation>
    <PMID>21226862</PMID>
  </reference>
  <reference>
    <citation>Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology. 2005 Jun;102(6):1110-5; discussion 5A. doi: 10.1097/00000542-200506000-00009.</citation>
    <PMID>15915022</PMID>
  </reference>
  <reference>
    <citation>Boyce JR, Ness T, Castroman P, Gleysteen JJ. A preliminary study of the optimal anesthesia positioning for the morbidly obese patient. Obes Surg. 2003 Feb;13(1):4-9. doi: 10.1381/096089203321136511.</citation>
    <PMID>12630606</PMID>
  </reference>
  <reference>
    <citation>Simon M, Wachs C, Braune S, de Heer G, Frings D, Kluge S. High-Flow Nasal Cannula Versus Bag-Valve-Mask for Preoxygenation Before Intubation in Subjects With Hypoxemic Respiratory Failure. Respir Care. 2016 Sep;61(9):1160-7. doi: 10.4187/respcare.04413. Epub 2016 Jun 7.</citation>
    <PMID>27274092</PMID>
  </reference>
  <reference>
    <citation>Teller LE, Alexander CM, Frumin MJ, Gross JB. Pharyngeal insufflation of oxygen prevents arterial desaturation during apnea. Anesthesiology. 1988 Dec;69(6):980-2. doi: 10.1097/00000542-198812000-00035. No abstract available.</citation>
    <PMID>3195773</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>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>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>March 23, 2018</last_update_submitted>
  <last_update_submitted_qc>March 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Tracey Straker</investigator_full_name>
    <investigator_title>Co-principal investigator, Attending Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This is a collaborative study, so the information will be shared with the researchers in Texas. However, we do not plan to use this information for other studies.</ipd_description>
  </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/NCT03009877
org study id: 2016-7360
nct id: NCT03009877
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient
      population. This study will examine whether Optiflow can do this, and compare the
      pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.
The use of high flow nasal cannula (HFNC) originated in neonatal care, and has become
      widespread in its application for patients that are high risk for hypoxemia, both in critical
      care and emergency settings. Therefore, high flow nasal oxygenation continues to be studied
      in airway management for preoxygenation, as well as maintenance of oxygenation in airway
      procedures. Optiflow™, a humidified high flow nasal cannula, has already been shown to be
      useful in preventing desaturation during intubation in ICU patients versus the
      non-rebreathing mask, in addition to, prolonging safe apnea time in patients with potential
      difficult airways. Additionally, preoxygenation with HFNC prior to intubation of patients in
      hypoxemic respiratory failure has also been shown to decrease desaturation during apnea
      compared to preoxygenation with traditional bag valve mask. The morbidly obese patient
      presents a separate group of challenges to the anesthesiologist in regards to mask
      ventilation and intubation. Obesity (along with other factors) has been shown to contribute
      to difficulty with mask ventilation. Obese patients have altered respiratory physiology,
      including decreased functional residual capacity, increased oxygen consumption and lower
      tidal volumes, as compared to the non-obese patient. These factors contribute to obese
      patients potentially having a shorter apnea time before desaturating during induction of
      general anesthesia, as compared to the non-obese patient. Weight is inversely correlated with
      safe apnea time. Optiflow™ may provide an opportunity to prolong apnea time in the morbidly
      obese patient population. If demonstrated to be efficacious as a method for preoxygenation
      and prolongation of apneic time, this could provide a safer environment for intubation in
      this particular patient population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to desaturation
time frame: up to 10 minutes
description: Intraoperatively, apneic time will be record from the time of administration of the muscle relaxant. The time until the first desaturation will be recorded. The maximum time of measurement will be 10 minutes.
measure: Time until hypercarbia > 65 mmHg
time frame: up to 10 minutes
description: The time until hypercarbia to more than 65 mmHg will be measured from the time of administration of the muscle relaxant. The time until transcutaneous CO2 is > 65 mmHg will be recorded, unless 10 minutes is reached before that level is reached.
measure: Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring
time frame: up to 10 minutes
description: Assessment of accurate correlation between transcutaneous CO2 monitoring, end tidal CO2, and/or PaCO2 will be performed up to 10 minutes.
arm group label: Preoxygenation with face mask
arm group type: Active Comparator
description: Standard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
arm group label: Preoxygenation via hi flow nasal cannula
arm group type: Experimental
description: The high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
intervention type: Device
intervention name: Optiflow F&P 850™ System
description: Optiflow™ (Fisher & Paykel Healthcare Limited, East Tamaki, Auckland-New Zealand) offers the ability to comfortably deliver a complete range of oxygen concentrations and flows to extend the traditional boundaries of oxygen therapy.
This will be placed on the patient immediately upon entering the operating room for 5 minutes, at 50 liters per minute then increased to 70 liters per minute after induction.
arm group label: Preoxygenation via hi flow nasal cannula
other name: High flow nasal cannula
intervention type: Device
intervention name: facemask
description: We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.
arm group label: Preoxygenation with face mask
other name: face mask
intervention type: Drug
intervention name: Rocuronium
description: Rocuronium will be administered after the ability to mask ventilate is determined.
arm group label: Preoxygenation via hi flow nasal cannula
arm group label: Preoxygenation with face mask
intervention type: Drug
intervention name: Propofol
description: Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
arm group label: Preoxygenation via hi flow nasal cannula
arm group label: Preoxygenation with face mask
intervention type: Drug
intervention name: Fentanyl
description: Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
arm group label: Preoxygenation via hi flow nasal cannula
arm group label: Preoxygenation with face mask
intervention type: Drug
intervention name: Midazolam
description: midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
arm group label: Preoxygenation via hi flow nasal cannula
arm group label: Preoxygenation with face mask
other name: Versed
intervention type: Device
intervention name: C-MAC Premium Video Intubation Platform-KARL STORZ
description: After patient is induced, the 5.5mm flexible intubation video scope (C-MAC Premium Video Intubation Platform-KARL STORZ) will then be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope (3 or 4 blade based on anesthesiologist's discretion).
arm group label: Preoxygenation via hi flow nasal cannula
arm group label: Preoxygenation with face mask
other name: videolaryngoscope and optical fiberoptic bronchoscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Irene Osborn, MD
role: Study Director
affiliation: Montefiore Medical Center
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PMID: 20400000
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Tracey Straker
investigator title: Co-principal investigator, Attending Anesthesiologist
mesh term: Obesity, Morbid
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Propofol
mesh term: Rocuronium
sharing ipd: Yes
ipd description: This is a collaborative study, so the information will be shared with the researchers in Texas. However, we do not plan to use this information for other studies.