Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask
NCT ID: NCT03009877
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Preoxygenation with face mask
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.
facemask
We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.
Rocuronium
Rocuronium will be administered after the ability to mask ventilate is determined.
Propofol
Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
Fentanyl
Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
Midazolam
midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
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).
Preoxygenation via hi flow nasal cannula
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.
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.
Rocuronium
Rocuronium will be administered after the ability to mask ventilate is determined.
Propofol
Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
Fentanyl
Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
Midazolam
midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
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).
Interventions
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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.
facemask
We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.
Rocuronium
Rocuronium will be administered after the ability to mask ventilate is determined.
Propofol
Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
Fentanyl
Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
Midazolam
midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \> 40 kg/m2
* American Society of Anesthesiology (ASA) Physical Status II-III
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
M.D. Anderson Cancer Center
OTHER
Montefiore Medical Center
OTHER
Responsible Party
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Tracey Straker
Co-principal investigator, Attending Anesthesiologist
Principal Investigators
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Irene Osborn, MD
Role: STUDY_DIRECTOR
Montefiore Medical Center
References
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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.
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.
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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.
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.
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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.
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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.
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.
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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.
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Other Identifiers
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2016-7360
Identifier Type: -
Identifier Source: org_study_id
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