<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/NCT03239236</url>
  </required_header>
  <id_info>
    <org_study_id>Modified RSI in morbidly obese</org_study_id>
    <nct_id>NCT03239236</nct_id>
  </id_info>
  <brief_title>Modified Rapid Sequence Induction in Morbidly Obese Patients</brief_title>
  <official_title>Modified Rapid Sequence Induction in Morbidly Obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</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>
      This study investigates the effect of 4 different methods of rapid sequence induction (RSI)&#xD;
      in morbidly obese patients on the amount of air insufflation into the stomach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 adult patients with a body mass index &gt; 40 undergoing elective laparoscopic surgery will&#xD;
      be included. Patients with a history of previous bariatric surgery or with an anticipated&#xD;
      difficult airway will be excluded.&#xD;
&#xD;
      The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.&#xD;
&#xD;
      All groups will receive standardized preoperative continuous positive airway pressure (CPAP)&#xD;
      therapy.&#xD;
&#xD;
      In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight&#xD;
      fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be&#xD;
      administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl&#xD;
      250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed&#xD;
      after 1 minute. No bag mask ventilation will be performed in-between.&#xD;
&#xD;
      Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3&#xD;
      minutes. The same induction agents as in group one will be administered. PEEP via facemask&#xD;
      will be continued for one minute and tracheal intubation will be performed.&#xD;
&#xD;
      Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with&#xD;
      additional pressure support of 8 mbar and a back up ventilation frequency will be set to&#xD;
      10/min. After the same induction agents are given as in group 1, patients will receive&#xD;
      non-invasive ventilation via ventilator at the settings described earlier for group 3.&#xD;
&#xD;
      Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be&#xD;
      applied during the non invasive ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no funding available&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 2021</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of air aspirated with a gastric tube</measure>
    <time_frame>at the beginning of the laparoscopy</time_frame>
    <description>The amount of air that can be aspirated via a nasogastric tube at the beginning of laparoscopy. A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastric inflation</measure>
    <time_frame>at the beginning of laparoscopy</time_frame>
    <description>The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded. These images will afterwards be reviewed in a blinded fashion by three different investigators. The investigators will rate their impression of gastric inflation (empty, mildly inflated, inflated, very inflated).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>partial pressure of oxygen in arterial blood (paO2)</measure>
    <time_frame>before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated</time_frame>
    <description>Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, after intubation.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Anesthesia Intubation Complication</condition>
  <arm_group>
    <arm_group_label>t-RSI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.&#xD;
Arterial blood gas samples will be taken at different time points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>m-RSI-PEEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.&#xD;
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.&#xD;
Arterial blood gas samples will be taken at different time points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>m-RSI-vent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.&#xD;
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.&#xD;
Arterial blood gas samples will be taken at different time points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as &quot;modified rapid sequence induction with intermittent ventilation&quot; arm with additional cricoid pressure.&#xD;
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.&#xD;
Arterial blood gas samples will be taken at different time points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rapid sequence induction t-RSI</intervention_name>
    <description>Preoxygenation via face mask, no ventilation with no PEEP until intubation</description>
    <arm_group_label>t-RSI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rapid sequence induction m-RSI-PEEP</intervention_name>
    <description>Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.</description>
    <arm_group_label>m-RSI-PEEP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rapid sequence induction m-RSI-vent</intervention_name>
    <description>Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.</description>
    <arm_group_label>m-RSI-vent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>m-RSI-vent-cric</intervention_name>
    <description>Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.</description>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cricoid Pressure</intervention_name>
    <description>Cricoid Pressure will be applied during RSI until laryngoscopy</description>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anesthetics</intervention_name>
    <description>Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight).</description>
    <arm_group_label>m-RSI-PEEP</arm_group_label>
    <arm_group_label>m-RSI-vent</arm_group_label>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
    <arm_group_label>t-RSI</arm_group_label>
    <other_name>Induction Agents</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Aspiration of gastric air via nasogastric tube</intervention_name>
    <description>A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.</description>
    <arm_group_label>m-RSI-PEEP</arm_group_label>
    <arm_group_label>m-RSI-vent</arm_group_label>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
    <arm_group_label>t-RSI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Impression of gastric inflation at laparoscopy.</intervention_name>
    <description>The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded.</description>
    <arm_group_label>m-RSI-PEEP</arm_group_label>
    <arm_group_label>m-RSI-vent</arm_group_label>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
    <arm_group_label>t-RSI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Arterial blood gas</intervention_name>
    <description>Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated.</description>
    <arm_group_label>m-RSI-PEEP</arm_group_label>
    <arm_group_label>m-RSI-vent</arm_group_label>
    <arm_group_label>m-RSI-vent-cric</arm_group_label>
    <arm_group_label>t-RSI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  American Society of Anesthesiology Class 1-3&#xD;
&#xD;
          -  Elective laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding patients&#xD;
&#xD;
          -  Previous bariatric surgery&#xD;
&#xD;
          -  Anticipated difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Walter Plöchl, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Thomas Hamp</investigator_full_name>
    <investigator_title>Univ. Prof. Dr.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <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/NCT03239236
org study id: Modified RSI in morbidly obese
nct id: NCT03239236
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the effect of 4 different methods of rapid sequence induction (RSI)
      in morbidly obese patients on the amount of air insufflation into the stomach.
100 adult patients with a body mass index > 40 undergoing elective laparoscopic surgery will
      be included. Patients with a history of previous bariatric surgery or with an anticipated
      difficult airway will be excluded.

      The randomization will be 1:1:1:1 stratified for gastro-esophageal reflux disease.

      All groups will receive standardized preoperative continuous positive airway pressure (CPAP)
      therapy.

      In the operation theater, Group one will receive pre-oxygenation for 3 minutes via a tight
      fitting face mask without positive end-expiratory pressure (PEEP). Induction agents will be
      administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl
      250mcg, Rocuronium 1,2mg/kg ideal body weight) and tracheal intubation will be performed
      after 1 minute. No bag mask ventilation will be performed in-between.

      Group 2 will receive pre-oxygenation via a tight face mask with a PEEP of 10 mbar for 3
      minutes. The same induction agents as in group one will be administered. PEEP via facemask
      will be continued for one minute and tracheal intubation will be performed.

      Group 3 will receive pre-oxygenation via a tight fitting facemask with a PEEP of 10 mbar with
      additional pressure support of 8 mbar and a back up ventilation frequency will be set to
      10/min. After the same induction agents are given as in group 1, patients will receive
      non-invasive ventilation via ventilator at the settings described earlier for group 3.

      Group 4 will receive the same induction as group 3, in addition a cricoid pressure will be
      applied during the non invasive ventilation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Amount of air aspirated with a gastric tube
time frame: at the beginning of the laparoscopy
description: The amount of air that can be aspirated via a nasogastric tube at the beginning of laparoscopy. A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
measure: Gastric inflation
time frame: at the beginning of laparoscopy
description: The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded. These images will afterwards be reviewed in a blinded fashion by three different investigators. The investigators will rate their impression of gastric inflation (empty, mildly inflated, inflated, very inflated).
measure: partial pressure of oxygen in arterial blood (paO2)
time frame: before pre oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated
description: Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, after intubation.
arm group label: t-RSI
arm group type: Experimental
description: Rapid sequence induction t-RSI. Traditional rapid sequence induction with Anesthetics. Preoxygenation via face mask, no ventilation with no PEEP until intubation. Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
arm group label: m-RSI-PEEP
arm group type: Experimental
description: Rapid sequence induction m-RSI-PEEP. Modified rapid sequence induction with Anesthetics and PEEP. Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
arm group label: m-RSI-vent
arm group type: Experimental
description: Rapid sequence induction m-RSI-vent. Modified rapid sequence induction with Anesthetics and intermittent ventilation. Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
arm group label: m-RSI-vent-cric
arm group type: Experimental
description: Rapid sequence induction m-RSI-vent-cric. Modified rapid sequence induction with Anesthetics and intermittent ventilation and cricoid pressure. Same as "modified rapid sequence induction with intermittent ventilation" arm with additional cricoid pressure.
Aspiration of gastric air via nasogastric tube at the beginning of laparoscopy. Impression of gastric inflation at laparoscopy will be assessed by taking images of the stomach at the beginning of laparoscopy.
Arterial blood gas samples will be taken at different time points.
intervention type: Procedure
intervention name: Rapid sequence induction t-RSI
description: Preoxygenation via face mask, no ventilation with no PEEP until intubation
arm group label: t-RSI
intervention type: Procedure
intervention name: Rapid sequence induction m-RSI-PEEP
description: Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
arm group label: m-RSI-PEEP
intervention type: Procedure
intervention name: Rapid sequence induction m-RSI-vent
description: Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
arm group label: m-RSI-vent
intervention type: Procedure
intervention name: m-RSI-vent-cric
description: Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
arm group label: m-RSI-vent-cric
intervention type: Procedure
intervention name: Cricoid Pressure
description: Cricoid Pressure will be applied during RSI until laryngoscopy
arm group label: m-RSI-vent-cric
intervention type: Drug
intervention name: Anesthetics
description: Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight).
arm group label: m-RSI-PEEP
arm group label: m-RSI-vent
arm group label: m-RSI-vent-cric
arm group label: t-RSI
other name: Induction Agents
intervention type: Diagnostic Test
intervention name: Aspiration of gastric air via nasogastric tube
description: A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
arm group label: m-RSI-PEEP
arm group label: m-RSI-vent
arm group label: m-RSI-vent-cric
arm group label: t-RSI
intervention type: Diagnostic Test
intervention name: Impression of gastric inflation at laparoscopy.
description: The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded.
arm group label: m-RSI-PEEP
arm group label: m-RSI-vent
arm group label: m-RSI-vent-cric
arm group label: t-RSI
intervention type: Diagnostic Test
intervention name: Arterial blood gas
description: Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated.
arm group label: m-RSI-PEEP
arm group label: m-RSI-vent
arm group label: m-RSI-vent-cric
arm group label: t-RSI
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Walter Plöchl, Professor
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Thomas Hamp
investigator title: Univ. Prof. Dr.
mesh term: Anesthetics
sharing ipd: Undecided