Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask
NCT03009877 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2018-03-27
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.
Conditions
- Obesity, Morbid
Interventions
- DEVICE
-
Optiflow F&P 850™ System
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.
- DEVICE
-
facemask
We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.
- DRUG
-
Rocuronium
Rocuronium will be administered after the ability to mask ventilate is determined.
- DRUG
-
Propofol
Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
- DRUG
-
Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
- DRUG
-
Midazolam
midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
- DEVICE
-
C-MAC Premium Video Intubation Platform-KARL STORZ
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).
Sponsors & Collaborators
-
The University of Texas Health Science Center, Houston
collaborator OTHER -
M.D. Anderson Cancer Center
collaborator OTHER -
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Irene Osborn, MD · Montefiore Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-07-31
- Primary Completion
- 2019-05-31
- Completion
- 2019-12-31
- FDA Device
- Yes
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