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The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature.
This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.
Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes.
Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight.
The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume.
Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 > 90 % and a longer non-hypoxic apnea time (Sat O2 >90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique.
We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supine | Experimental | NIPPV and Tidal volume |
|
| Beach-chair (Back : 25 deg) | Experimental | NIPPV and Tidal volume |
|
| Proclive (Global 25 deg) | Experimental | NIPPV and Tidal volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIPPV | Procedure | Ventilation: non-invasive positive pressure ventilation (NIPPV) Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Residual Capacity | Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance. | After a 5 minutes pre-oxygenation period |
| Measure | Description | Time Frame |
|---|---|---|
| Diaphragmatic Amplitude. | Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described. | After a 5 minutes pre-oxygenation period |
| Respiratory Mechanics |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs | Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described. | At the end of a 5 minutes pre-oxygenation period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Etienne J Couture, MD | Laval University | Principal Investigator |
| Jean S Bussières, MD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec | Québec | Quebec | G1V4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17122570 | Background | Cheney FW, Posner KL, Lee LA, Caplan RA, Domino KB. Trends in anesthesia-related death and brain damage: A closed claims analysis. Anesthesiology. 2006 Dec;105(6):1081-6. doi: 10.1097/00000542-200612000-00007. | |
| 21447488 | Background | Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29. |
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Recruitment was held between April 14th 2014 and June 26th 2014 by telephonic solicitation and through the preoperative bariatric clinic of our institution.
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| ID | Title | Description |
|---|---|---|
| FG000 | Position and Spontaneous vs Pressure Support | The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order. Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Position and Spontaneous vs Pressure Support | The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order. Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Residual Capacity | Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance. | Posted | Mean | Standard Deviation | ml | After a 5 minutes pre-oxygenation period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Position and Spontaneous vs Pressure Support | The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order. Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean S. Bussières | Laval University | 418 656-8711 | jbuss@criucpq.ulaval.ca |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
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| Tidal volume | Procedure | Tidal volume spontaneous ventilation, no assistance. |
|
Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described. |
| At the end of a 5 minutes pre-oxygenation period |
| Patient's Comfort | Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described. | At the end of a 5 minutes pre-oxygenation period |
| 12873960 | Background | Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, Desmonts JM. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003 Aug;97(2):595-600. doi: 10.1213/01.ANE.0000072547.75928.B0. |
| 8110546 | Background | 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. |
| 1984382 | Background | 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. |
| 9357902 | Background | Benumof JL, Dagg R, Benumof R. Critical hemoglobin desaturation will occur before return to an unparalyzed state following 1 mg/kg intravenous succinylcholine. Anesthesiology. 1997 Oct;87(4):979-82. doi: 10.1097/00000542-199710000-00034. No abstract available. |
| 1931404 | Background | Berthoud MC, Peacock JE, Reilly CS. Effectiveness of preoxygenation in morbidly obese patients. Br J Anaesth. 1991 Oct;67(4):464-6. doi: 10.1093/bja/67.4.464. |
| 23836064 | Background | Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9. |
| 19399574 | Background | Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28. |
| 16779465 | Background | Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. doi: 10.1155/2006/834786. |
| 15915022 | Background | 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. |
| 12630606 | Background | Boyce JR, Ness T, Castroman P, Gleysteen JJ. A preliminary study of the optimal anesthesia positioning for the morbidly obese patient. Obes Surg. 2003 Feb;13(1):4-9. doi: 10.1381/096089203321136511. |
| 8167771 | Background | Burns SM, Egloff MB, Ryan B, Carpenter R, Burns JE. Effect of body position on spontaneous respiratory rate and tidal volume in patients with obesity, abdominal distension and ascites. Am J Crit Care. 1994 Mar;3(2):102-6. |
| 15105237 | Background | Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99. |
| 15673897 | Background | Gander S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Positive end-expiratory pressure during induction of general anesthesia increases duration of nonhypoxic apnea in morbidly obese patients. Anesth Analg. 2005 Feb;100(2):580-584. doi: 10.1213/01.ANE.0000143339.40385.1B. |
| 18931236 | Background | Delay JM, Sebbane M, Jung B, Nocca D, Verzilli D, Pouzeratte Y, Kamel ME, Fabre JM, Eledjam JJ, Jaber S. The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study. Anesth Analg. 2008 Nov;107(5):1707-13. doi: 10.1213/ane.0b013e318183909b. |
| 21478734 | Background | Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba. |
| 18431116 | Background | Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. |
| 29435810 | Derived | Couture EJ, Provencher S, Somma J, Lellouche F, Marceau S, Bussieres JS. Effect of position and positive pressure ventilation on functional residual capacity in morbidly obese patients: a randomized trial. Can J Anaesth. 2018 May;65(5):522-528. doi: 10.1007/s12630-018-1050-1. Epub 2018 Jan 18. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| OG002 |
| 3. Beach Chair (Back 25 Deg) + NIPPV |
Intervention 3 : Beach chair (Back 25 deg) + NIPPV |
| OG003 | 4. Beach Chair (Back 25 Deg) + Tidal Volume Spontaneous Ventil | Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation |
| OG004 | 5. Proclive (Global 25 Deg) + NIPPV | Intervention 5 : Proclive (Global 25 deg) + NIPPV |
| OG005 | 6. Proclive (Global 25 Deg) + Tidal Volume Spontaneous Ventila | Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation |
|
|
| Secondary | Diaphragmatic Amplitude. | Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described. | Not Posted | After a 5 minutes pre-oxygenation period | Participants |
| Secondary | Respiratory Mechanics | Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described. | Not Posted | At the end of a 5 minutes pre-oxygenation period | Participants |
| Secondary | Patient's Comfort | Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described. | Not Posted | At the end of a 5 minutes pre-oxygenation period | Participants |
| Other Pre-specified | Vital Signs | Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described. | Not Posted | At the end of a 5 minutes pre-oxygenation period | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012129 |
| Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |