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Mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. For general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. Medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. In this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.
Mask ventilation is a foundation of airway management after the initial induction of anesthesia. It allows for adequate oxygenation of the patient to buy enough time for intubation, during which the patient is not ventilated. However, in some patients mask ventilation may be difficult - older than 55 years, heavier (BMI > 26 kg/m^2), with no teeth, having a beard or sleep apnea. Inadequate ventilation, if not corrected, can result in decreasing oxygen saturation to dangerous levels - which could lead to devastating complications. As a result, the efficacy of mask ventilation is of critical importance to patient safety after the induction of anesthesia.
A recent study proposed that mask ventilation could be improved simply by turning a patient's head. The study showed that rotating a patient's head to a 45 degree angle significantly improved mask ventilation when compared with the head placed in a neutral position. However, this study was done in patients with a BMI lass than 35. As such, the effects of head rotation on the efficacy of mask ventilation has not been studied in patients with a BMI of 35 and greater.
Obesity (BMI ≥ 30 kg/m^2) affects almost 40% of US adults and is one of the most prevalent health concerns in our society. It is a predictor of difficult mask ventilation because it is associated with increased upper airway obstruction, decreased airway patency, and decreased lung volumes such as functional residual capacity (FRC). If previous findings in regard to the effects of 45 degree head rotation on the efficacy of ventilation hold true in the obese patient, then this study will show that head rotation could be used as a simple way to improve the efficacy of mask ventilation for patients with a BMI of 35 and above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) |
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| Group B | Experimental | Head Rotation During Face Mask Ventilation. Step 1: Head Rotation (1 Minute), Step 2: Neutral Position (1 minute), Step 3, Head Rotation (1 Minute) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head Rotation During Face Mask Ventilation | Procedure | Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Measured in mL | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Measured in mL | Day 1 |
| Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Measured in mm Hg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Mraovic, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Columbia | Missouri | 65212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24122033 | Background | Langeron O, Birenbaum A, Le Sache F, Raux M. Airway management in obese patient. Minerva Anestesiol. 2014 Mar;80(3):382-92. Epub 2013 Oct 14. | |
| 17065880 | Background | Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Head Rotation During Face Mask Ventilation: Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). Medline Top Valve Anesthesia Mask: Face mask used per standard of care to provide oxygen to subjects before surgical procedures. |
| FG001 | Group B | Head Rotation During Face Mask Ventilation. Step 1: Head Rotation (1 Minute), Step 2: Neutral Position (1 minute), Step 3, Head Rotation (1 Minute) Head Rotation During Face Mask Ventilation: Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). Medline Top Valve Anesthesia Mask: Face mask used per standard of care to provide oxygen to subjects before surgical procedures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Head Rotation During Face Mask Ventilation: Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). Medline Top Valve Anesthesia Mask: Face mask used per standard of care to provide oxygen to subjects before surgical procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Measured in mL | Both groups' patients' heads were rotated, however, in the Neutral Position group the patients' heads started in neutral position, while the Head Rotation group's heads started in rotated position. Data were not collected for each 1-minute change within the groups. | Posted | Mean | Standard Deviation | Milliliter | Day 1 |
|
One day
1 patient from group B experienced apnea after intubation had been completed.
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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 | Group A | Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Head Rotation During Face Mask Ventilation: Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). Medline Top Valve Anesthesia Mask: Face mask used per standard of care to provide oxygen to subjects before surgical procedures. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris Mraovic | University of Missouri-Columbia | 5738822568 | mraovicb@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2018 | May 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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Participants will be assigned into one of two groups (per a randomization schedule) for face mask ventilation. The sequence of face mask ventilation head positions will be determined by group assignment. Each position will be performed for one minute. Group A: (1) neutral position, (2) head rotation, (3) neutral position. Group B: (1) head rotation, (2) neutral position, (3) head rotation.
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The surgeon, anesthesiologist, operating room staff, and participants will not know the group assignment at the time of subject recruitment. No blinding will occur during the clinical portion of the study or during data analysis.
| Medline Top Valve Anesthesia Mask | Device | Face mask used per standard of care to provide oxygen to subjects before surgical procedures. |
|
|
| Day 1 |
| Maximal and Average Airway Flow During Mask Ventilation | Measured in L/min | Day 1 |
| Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Measured in % Delta O2 saturation drop is the difference between 100% oxygen saturation and the lowest oxygen saturation measured, e.g., 100 - 96 (lowest measured) = 4 (delta). | Day 1 |
| Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Measured in % Delta O2 saturation drop is the difference between 100% oxygen saturation and the lowest oxygen saturation measured, e.g., 100 - 96 (lowest measured) = 4 (delta). | Day 1 |
| 19293691 | Background | Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87. |
| 28009638 | Background | Itagaki T, Oto J, Burns SM, Jiang Y, Kacmarek RM, Mountjoy JR. The effect of head rotation on efficiency of face mask ventilation in anaesthetised apnoeic adults: A randomised, crossover study. Eur J Anaesthesiol. 2017 Jul;34(7):432-440. doi: 10.1097/EJA.0000000000000582. |
| 29155689 | Background | Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity Among Adults and Youth: United States, 2015-2016. NCHS Data Brief. 2017 Oct;(288):1-8. |
| BG001 | Group B | Head Rotation During Face Mask Ventilation. Step 1: Head Rotation (1 Minute), Step 2: Neutral Position (1 minute), Step 3, Head Rotation (1 Minute) Head Rotation During Face Mask Ventilation: Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). Medline Top Valve Anesthesia Mask: Face mask used per standard of care to provide oxygen to subjects before surgical procedures. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Head Rotation |
Head Rotation During Face Mask Ventilation. Step 1: Head Rotation (1 Minute), Step 2: Neutral Position (1 minute), Step 3, Head Rotation (1 Minute) Patients' heads started in 45 degree rotated position, and was returned to normal position for 1 minute, then returned to 45 degree rotated position during the 3-minute preoxygenation prior to anesthesia induction. |
|
|
| Secondary | Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Measured in mL | Both groups' patients' heads were rotated, however, in the Neutral Position group the patients' heads started in neutral position, while the Head Rotation group's heads started in rotated position. Data were not collected for each 1-minute change within the groups. | Posted | Mean | Standard Deviation | Milliliter | Day 1 |
|
|
|
| Secondary | Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Measured in mm Hg | Both groups' patients' heads were rotated, however, in the Neutral Position group the patients' heads started in neutral position, while the Head Rotation group's heads started in rotated position. Data were not collected for each 1-minute change within the groups. | Posted | Mean | Standard Deviation | Millimeters of mercury | Day 1 |
|
|
|
| Secondary | Maximal and Average Airway Flow During Mask Ventilation | Measured in L/min | Both groups' patients' heads were rotated, however, in the Neutral Position group the patients' heads started in neutral position, while the Head Rotation group's heads started in rotated position. Data were not collected for each 1-minute change within the groups. | Posted | Mean | Standard Deviation | Liters per minute | Day 1 |
|
|
|
| Secondary | Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Measured in % Delta O2 saturation drop is the difference between 100% oxygen saturation and the lowest oxygen saturation measured, e.g., 100 - 96 (lowest measured) = 4 (delta). | Both groups' patients' heads were rotated, however, in the Neutral Position group the patients' heads started in neutral position, while the Head Rotation group's heads started in rotated position. Data were not collected for each 1-minute change within the groups. | Posted | Mean | Standard Deviation | Percentage | Day 1 |
|
|
|
| Secondary | Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Measured in % Delta O2 saturation drop is the difference between 100% oxygen saturation and the lowest oxygen saturation measured, e.g., 100 - 96 (lowest measured) = 4 (delta). | Both groups' patients' heads were rotated, however, in the Neutral Position group the patients' heads started in neutral position, while the Head Rotation group's heads started in rotated position. Data were not collected for each 1-minute change within the groups. | Posted | Mean | Standard Deviation | Percentage | Day 1 |
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|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Group B | Head Rotation During Face Mask Ventilation. Step 1: Head Rotation (1 Minute), Step 2: Neutral Position (1 minute), Step 3, Head Rotation (1 Minute) Head Rotation During Face Mask Ventilation: Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). Medline Top Valve Anesthesia Mask: Face mask used per standard of care to provide oxygen to subjects before surgical procedures. | 0 | 12 | 0 | 12 | 1 | 12 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |