Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
NCT ID: NCT03529461
Last Updated: 2019-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2017-04-25
2018-04-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Control
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
Rescue non-invasive positive pressure ventilation through nasal mask
If desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
Secondary rescue maneuvers
If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \> 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
Experimental
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
Non-invasive positive pressure ventilation through nasal mask
Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
Secondary rescue maneuvers
If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \> 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
Interventions
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Non-invasive positive pressure ventilation through nasal mask
Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
Rescue non-invasive positive pressure ventilation through nasal mask
If desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
Secondary rescue maneuvers
If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat \> 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
Eligibility Criteria
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Inclusion Criteria
* BMI 40-60
Exclusion Criteria
* Previous weight loss surgery or stomach surgery
* BMI \> 60 and BMI \< 40
* Active smokers
* Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks
* Lung disease, COPD asthma, cystic fibrosis, sarcoidosis
* Baseline O2 saturation less than or equal to 94%
* Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol Hospital
OTHER
Responsible Party
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Makram Gedeon, MD
Medical director of bariatric surgery program, principal investigator
Principal Investigators
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Makram M Gedeon, MD
Role: PRINCIPAL_INVESTIGATOR
Bristol Hospital
Locations
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Bristol Hospital
Bristol, Connecticut, United States
Countries
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References
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Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.
Arakawa H, Kaise M, Sumiyama K, Saito S, Suzuki T, Tajiri H. Does pulse oximetry accurately monitor a patient's ventilation during sedated endoscopy under oxygen supplementation? Singapore Med J. 2013 Apr;54(4):212-5. doi: 10.11622/smedj.2013075.
De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
Fouladpour N, Jesudoss R, Bolden N, Shaman Z, Auckley D. Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Anesth Analg. 2016 Jan;122(1):145-51. doi: 10.1213/ANE.0000000000000841.
Gay PC. Complications of noninvasive ventilation in acute care. Respir Care. 2009 Feb;54(2):246-57; discussion 257-8.
Gomez V, Bhalla R, Heckman MG, Florit PT, Diehl NN, Rawal B, Lynch SA, Loeb DS. Routine Screening Endoscopy before Bariatric Surgery: Is It Necessary? Bariatr Surg Pract Patient Care. 2014 Dec 1;9(4):143-149. doi: 10.1089/bari.2014.0024.
Goudra BG, Singh PM, Penugonda LC, Speck RM, Sinha AC. Significantly reduced hypoxemic events in morbidly obese patients undergoing gastrointestinal endoscopy: Predictors and practice effect. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):71-7. doi: 10.4103/0970-9185.125707.
McVay T, Fang JC, Taylor L, Au A, Williams W, Presson AP, Al-Dulaimi R, Volckmann E, Ibele A. Safety Analysis of Bariatric Patients Undergoing Outpatient Upper Endoscopy with Non-Anesthesia Administered Propofol Sedation. Obes Surg. 2017 Jun;27(6):1501-1507. doi: 10.1007/s11695-016-2478-4.
Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.
Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016 Mar;4(3):E340-51. doi: 10.1055/s-0042-100719.
Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.
Soto RG, Davis M, Faulkner MJ. A comparison of the incidence of hypercapnea in non-obese and morbidly obese peri-operative patients using the SenTec transcutaneous pCO(2) monitor. J Clin Monit Comput. 2014 Jun;28(3):293-8. doi: 10.1007/s10877-013-9534-6. Epub 2013 Nov 29.
Wani S, Azar R, Hovis CE, Hovis RM, Cote GA, Hall M, Waldbaum L, Kushnir V, Early D, Mullady DK, Murad F, Edmundowicz SA, Jonnalagadda SS. Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures. Gastrointest Endosc. 2011 Dec;74(6):1238-47. doi: 10.1016/j.gie.2011.09.006.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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20170730
Identifier Type: -
Identifier Source: org_study_id