Apneic Oxygenation With a Nasal Cannula in the Obese and Morbidly Obese Surgical Patient
NCT ID: NCT03671837
Last Updated: 2020-03-11
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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COMPLETED
NA
135 participants
INTERVENTIONAL
2017-07-12
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
QUADRUPLE
Study Groups
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Oyxgen
Nasal Insufflation with 15 L/min O2 and a nasopharyngeal airway
Oxygen
15 L/min O2
Air
Nasal Insufflation with 15 L/min air and a nasopharyngeal airway
Air
15 L/min air
Interventions
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Oxygen
15 L/min O2
Air
15 L/min air
Eligibility Criteria
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Inclusion Criteria
* Obesity (BMI ≥ 30 kg/m2 ≤ 40 kg/m2)
* Morbid obesity (BMI ≥ 40 kg/m2)
* Scheduled for a non-emergent operation that requires general endotracheal anesthesia
* Willing and able to consent in English or Spanish
* No current history of advanced pulmonary or cardiovascular disease
Exclusion Criteria
* BMI \< 30 kg/m2
* Patient does not speak English or Spanish
* Family or personal history of malignant hyperthermia
* Patient refusal
* Monitored anesthesia care (MAC) or regional anesthesia planned
* Pregnant or nursing women
* "Stat" (emergent) cases
* Moderate to severe pulmonary disease (e.g., asthma, COPD, pulmonary fibrosis, pulmonary hypertension)
* Respiratory infection within the past 14 days (e.g., pneumonia, bronchitis)
* SpO2 \< 97% on room air
* Moderate to severe cardiac disease (e.g., CHF, CAD, aortic stenosis)
* Severe gastroesophageal reflux disease (GERD)
* Nasal obstruction (e.g., tumor)
* Elevated intracranial pressure (e.g., brain tumor)
* History of difficult airway
18 Years
80 Years
ALL
Yes
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Tiffany B Moon
Associate Professor
Principal Investigators
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Tiffany Moon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Parkland Health & Hospital System
Dallas, Texas, United States
Countries
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References
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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.
Huang KC, Kormas N, Steinbeck K, Loughnan G, Caterson ID. Resting metabolic rate in severely obese diabetic and nondiabetic subjects. Obes Res. 2004 May;12(5):840-5. doi: 10.1038/oby.2004.101.
McCahon RA, Hardman JG. Fighting for breath: apnoea vs the anaesthetist. Anaesthesia. 2007 Feb;62(2):105-8. doi: 10.1111/j.1365-2044.2007.04932.x. No abstract available.
Baraka AS, Taha SK, Siddik-Sayyid SM, Kanazi GE, El-Khatib MF, Dagher CM, Chehade JM, Abdallah FW, Hajj RE. Supplementation of pre-oxygenation in morbidly obese patients using nasopharyngeal oxygen insufflation. Anaesthesia. 2007 Aug;62(8):769-73. doi: 10.1111/j.1365-2044.2007.05104.x.
Baraka AS, Taha SK, Aouad MT, El-Khatib MF, Kawkabani NI. Preoxygenation: comparison of maximal breathing and tidal volume breathing techniques. Anesthesiology. 1999 Sep;91(3):612-6. doi: 10.1097/00000542-199909000-00009.
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.
Lopez PP, Stefan B, Schulman CI, Byers PM. Prevalence of sleep apnea in morbidly obese patients who presented for weight loss surgery evaluation: more evidence for routine screening for obstructive sleep apnea before weight loss surgery. Am Surg. 2008 Sep;74(9):834-8.
Heier T, Feiner JR, Lin J, Brown R, Caldwell JE. Hemoglobin desaturation after succinylcholine-induced apnea: a study of the recovery of spontaneous ventilation in healthy volunteers. Anesthesiology. 2001 May;94(5):754-9. doi: 10.1097/00000542-200105000-00011.
Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.
FRUMIN MJ, EPSTEIN RM, COHEN G. Apneic oxygenation in man. Anesthesiology. 1959 Nov-Dec;20:789-98. doi: 10.1097/00000542-195911000-00007. No abstract available.
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.
Damia G, Mascheroni D, Croci M, Tarenzi L. Perioperative changes in functional residual capacity in morbidly obese patients. Br J Anaesth. 1988 Apr;60(5):574-8. doi: 10.1093/bja/60.5.574.
Don HF, Wahba M, Cuadrado L, Kelkar K. The effects of anesthesia and 100 per cent oxygen on the functional residual capacity of the lungs. Anesthesiology. 1970 Jun;32(6):521-9. doi: 10.1097/00000542-197006000-00012. No abstract available.
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.
Dyett JF, Moser MS, Tobin AE. Prospective observational study of emergency airway management in the critical care environment of a tertiary hospital in Melbourne. Anaesth Intensive Care. 2015 Sep;43(5):577-86. doi: 10.1177/0310057X1504300505.
Sakles JC, Mosier JM, Patanwala AE, Dicken JM. Apneic oxygenation is associated with a reduction in the incidence of hypoxemia during the RSI of patients with intracranial hemorrhage in the emergency department. Intern Emerg Med. 2016 Oct;11(7):983-92. doi: 10.1007/s11739-016-1396-8. Epub 2016 Feb 4.
Other Identifiers
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STU 022017-074
Identifier Type: -
Identifier Source: org_study_id
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