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Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask

Primary Purpose

Obesity, Morbid

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optiflow F&P 850™ System
facemask
Rocuronium
Propofol
Fentanyl
Midazolam
C-MAC Premium Video Intubation Platform-KARL STORZ
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
  • BMI > 40 kg/m2
  • American Society of Anesthesiology (ASA) Physical Status II-III

Exclusion Criteria:

  • Chronic hypoxemia (SpO2 <94% on room air or on home oxygen)
  • Acute respiratory failure
  • Coronary artery disease and/or congestive heart failure
  • Moderate-Severe pulmonary hypertension and/or RV dysfunction
  • Full stomach (recently eaten)
  • Pregnancy
  • Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)
  • Respiratory tract pathology
  • Facial Abnormality
  • American Society of Anesthesiology (ASA) Physical Status IV-V

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Preoxygenation with face mask

    Preoxygenation via hi flow nasal cannula

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Time to desaturation
    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.

    Secondary Outcome Measures

    Time until hypercarbia > 65 mmHg
    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.
    Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring
    Assessment of accurate correlation between transcutaneous CO2 monitoring, end tidal CO2, and/or PaCO2 will be performed up to 10 minutes.

    Full Information

    First Posted
    December 21, 2016
    Last Updated
    March 23, 2018
    Sponsor
    Montefiore Medical Center
    Collaborators
    The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03009877
    Brief Title
    Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask
    Official Title
    Preoxygenation With Optiflow™, a High Flow Nasal Cannula (HFNC), is Superior to Preoxygenation With Facemask in Morbidly Obese Patients Undergoing General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    withdrawn prior to IRB approval
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Montefiore Medical Center
    Collaborators
    The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Preoxygenation with face mask
    Arm Type
    Active Comparator
    Arm 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 Title
    Preoxygenation via hi flow nasal cannula
    Arm Type
    Experimental
    Arm 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(s)
    Optiflow F&P 850™ System
    Other Intervention Name(s)
    High flow nasal cannula
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    facemask
    Other Intervention Name(s)
    face mask
    Intervention Description
    We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Rocuronium
    Intervention Description
    Rocuronium will be administered after the ability to mask ventilate is determined.
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Other Intervention Name(s)
    Versed
    Intervention Description
    midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
    Intervention Type
    Device
    Intervention Name(s)
    C-MAC Premium Video Intubation Platform-KARL STORZ
    Other Intervention Name(s)
    videolaryngoscope and optical fiberoptic bronchoscope
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Time to desaturation
    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.
    Time Frame
    up to 10 minutes
    Secondary Outcome Measure Information:
    Title
    Time until hypercarbia > 65 mmHg
    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.
    Time Frame
    up to 10 minutes
    Title
    Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring
    Description
    Assessment of accurate correlation between transcutaneous CO2 monitoring, end tidal CO2, and/or PaCO2 will be performed up to 10 minutes.
    Time Frame
    up to 10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia BMI > 40 kg/m2 American Society of Anesthesiology (ASA) Physical Status II-III Exclusion Criteria: Chronic hypoxemia (SpO2 <94% on room air or on home oxygen) Acute respiratory failure Coronary artery disease and/or congestive heart failure Moderate-Severe pulmonary hypertension and/or RV dysfunction Full stomach (recently eaten) Pregnancy Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma) Respiratory tract pathology Facial Abnormality American Society of Anesthesiology (ASA) Physical Status IV-V
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Irene Osborn, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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.
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