Noninvasive Ventilation
Conditions
Keywords
Face Mask, Obesity, Anesthetized Adult, Ventilation, Head Rotation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHead 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).
DEVICEMedline Top Valve Anesthesia Mask
Face mask used per standard of care to provide oxygen to subjects before surgical procedures.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * ASA Physical Status Classification I-III * Body Mass Index (BMI) ≥ 35 kg/m\^2
Exclusion criteria
* Inability to obtain written informed consent * Pregnant or breastfeeding * Limited head rotation or neck extension * Subjects with expected or history difficult intubation * Large beard * Orogastric (OG)/nasogastric (NG) tube * Gastroesophageal Reflux Disease (GERD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Day 1 | Measured in mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Day 1 | Measured in mL |
| Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Day 1 | Measured in mm Hg |
| Maximal and Average Airway Flow During Mask Ventilation | Day 1 | Measured in L/min |
| Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Day 1 | 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). |
| Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Day 1 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 12 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 20 Participants |
| Region of Enrollment United States | 9 participants | 12 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 0 / 9 | 1 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
Primary
Maximal and Average Expiratory Tidal Volume During Mask Ventilation
Measured in mL
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neutral Position | Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Maximal expiratory tidal volume | 25 Milliliter | Standard Deviation 11.39 |
| Neutral Position | Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Average expiratory tidal volume | 21.96 Milliliter | Standard Deviation 11.4 |
| Head Rotation | Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Maximal expiratory tidal volume | 26.52 Milliliter | Standard Deviation 10.31 |
| Head Rotation | Maximal and Average Expiratory Tidal Volume During Mask Ventilation | Average expiratory tidal volume | 23.33 Milliliter | Standard Deviation 9.9 |
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).
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neutral Position | Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Lowest O2 saturation drop on SpO2 | 2.28 Percentage | Standard Deviation 3.22 |
| Neutral Position | Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Delta O2 saturation drop on SpO2 | 3.22 Percentage | Standard Deviation 3.53 |
| Head Rotation | Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Lowest O2 saturation drop on SpO2 | 1.90 Percentage | Standard Deviation 2.51 |
| Head Rotation | Lowest and Delta O2 Saturation Drop on SpO2 During Intubation | Delta O2 saturation drop on SpO2 | 4.18 Percentage | Standard Deviation 4.02 |
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).
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neutral Position | Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Lowest O2 saturation drop on SpO2 | 96.78 Percentage | Standard Deviation 3.53 |
| Neutral Position | Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Delta O2 saturation drop on SpO2 | 3.22 Percentage | Standard Deviation 3.53 |
| Head Rotation | Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Lowest O2 saturation drop on SpO2 | 95.73 Percentage | Standard Deviation 3.95 |
| Head Rotation | Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation | Delta O2 saturation drop on SpO2 | 4.18 Percentage | Standard Deviation 4.02 |
Secondary
Maximal and Average Airway Flow During Mask Ventilation
Measured in L/min
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neutral Position | Maximal and Average Airway Flow During Mask Ventilation | Average airway flow | 97.95 Liters per minute | Standard Deviation 3.9 |
| Neutral Position | Maximal and Average Airway Flow During Mask Ventilation | Maximal airway flow | 97.69 Liters per minute | Standard Deviation 3.21 |
| Head Rotation | Maximal and Average Airway Flow During Mask Ventilation | Maximal airway flow | 98.03 Liters per minute | Standard Deviation 2.5 |
| Head Rotation | Maximal and Average Airway Flow During Mask Ventilation | Average airway flow | 96.78 Liters per minute | Standard Deviation 3.53 |
Secondary
Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation
Measured in mm Hg
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neutral Position | Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Maximal end-tidal CO2 | 23 Millimeters of mercury | Standard Deviation 13.88 |
| Neutral Position | Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Average end-tidal CO2 | 18.59 Millimeters of mercury | Standard Deviation 12.19 |
| Head Rotation | Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Maximal end-tidal CO2 | 31.36 Millimeters of mercury | Standard Deviation 5.26 |
| Head Rotation | Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation | Average end-tidal CO2 | 23.93 Millimeters of mercury | Standard Deviation 6.41 |
Secondary
Maximal and Average Inspiratory Tidal Volume During Mask Ventilation
Measured in mL
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neutral Position | Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Maximal inspiratory tidal volume | 415.48 Milliliter | Standard Deviation 182.27 |
| Neutral Position | Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Average inspiratory tidal volume | 339.86 Milliliter | Standard Deviation 243.76 |
| Head Rotation | Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Maximal inspiratory tidal volume | 395.35 Milliliter | Standard Deviation 158.73 |
| Head Rotation | Maximal and Average Inspiratory Tidal Volume During Mask Ventilation | Average inspiratory tidal volume | 296.45 Milliliter | Standard Deviation 90.86 |