Trial Outcomes & Findings for Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults (NCT NCT03876873)
NCT ID: NCT03876873
Last Updated: 2024-07-10
Results Overview
Measured in mL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Day 1
Results posted on
2024-07-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
Baseline characteristics by cohort
| Measure |
Group A
n=9 Participants
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.
|
Group B
n=12 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
Measured in mL
Outcome measures
| Measure |
Neutral Position
n=9 Participants
Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Patients' heads started in neutral position, and was rotated 45 degrees for 1 minute, then returned to neutral position during the 3-minute preoxygenation prior to anesthesia induction.
|
Head Rotation
n=11 Participants
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.
|
|---|---|---|
|
Maximal and Average Expiratory Tidal Volume During Mask Ventilation
Maximal expiratory tidal volume
|
25 Milliliter
Standard Deviation 11.39
|
26.52 Milliliter
Standard Deviation 10.31
|
|
Maximal and Average Expiratory Tidal Volume During Mask Ventilation
Average expiratory tidal volume
|
21.96 Milliliter
Standard Deviation 11.40
|
23.33 Milliliter
Standard Deviation 9.90
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Measured in mL
Outcome measures
| Measure |
Neutral Position
n=9 Participants
Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Patients' heads started in neutral position, and was rotated 45 degrees for 1 minute, then returned to neutral position during the 3-minute preoxygenation prior to anesthesia induction.
|
Head Rotation
n=11 Participants
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.
|
|---|---|---|
|
Maximal and Average Inspiratory Tidal Volume During Mask Ventilation
Maximal inspiratory tidal volume
|
415.48 Milliliter
Standard Deviation 182.27
|
395.35 Milliliter
Standard Deviation 158.73
|
|
Maximal and Average Inspiratory Tidal Volume During Mask Ventilation
Average inspiratory tidal volume
|
339.86 Milliliter
Standard Deviation 243.76
|
296.45 Milliliter
Standard Deviation 90.86
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Measured in mm Hg
Outcome measures
| Measure |
Neutral Position
n=9 Participants
Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Patients' heads started in neutral position, and was rotated 45 degrees for 1 minute, then returned to neutral position during the 3-minute preoxygenation prior to anesthesia induction.
|
Head Rotation
n=11 Participants
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.
|
|---|---|---|
|
Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation
Maximal end-tidal CO2
|
23 Millimeters of mercury
Standard Deviation 13.88
|
31.36 Millimeters of mercury
Standard Deviation 5.26
|
|
Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation
Average end-tidal CO2
|
18.59 Millimeters of mercury
Standard Deviation 12.19
|
23.93 Millimeters of mercury
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Measured in L/min
Outcome measures
| Measure |
Neutral Position
n=9 Participants
Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Patients' heads started in neutral position, and was rotated 45 degrees for 1 minute, then returned to neutral position during the 3-minute preoxygenation prior to anesthesia induction.
|
Head Rotation
n=11 Participants
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.
|
|---|---|---|
|
Maximal and Average Airway Flow During Mask Ventilation
Maximal airway flow
|
97.69 Liters per minute
Standard Deviation 3.21
|
98.03 Liters per minute
Standard Deviation 2.50
|
|
Maximal and Average Airway Flow During Mask Ventilation
Average airway flow
|
97.95 Liters per minute
Standard Deviation 3.90
|
96.78 Liters per minute
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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).
Outcome measures
| Measure |
Neutral Position
n=9 Participants
Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Patients' heads started in neutral position, and was rotated 45 degrees for 1 minute, then returned to neutral position during the 3-minute preoxygenation prior to anesthesia induction.
|
Head Rotation
n=11 Participants
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.
|
|---|---|---|
|
Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation
Lowest O2 saturation drop on SpO2
|
96.78 Percentage
Standard Deviation 3.53
|
95.73 Percentage
Standard Deviation 3.95
|
|
Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation
Delta O2 saturation drop on SpO2
|
3.22 Percentage
Standard Deviation 3.53
|
4.18 Percentage
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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).
Outcome measures
| Measure |
Neutral Position
n=9 Participants
Head Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) Patients' heads started in neutral position, and was rotated 45 degrees for 1 minute, then returned to neutral position during the 3-minute preoxygenation prior to anesthesia induction.
|
Head Rotation
n=11 Participants
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.
|
|---|---|---|
|
Lowest and Delta O2 Saturation Drop on SpO2 During Intubation
Lowest O2 saturation drop on SpO2
|
2.28 Percentage
Standard Deviation 3.22
|
1.90 Percentage
Standard Deviation 2.51
|
|
Lowest and Delta O2 Saturation Drop on SpO2 During Intubation
Delta O2 saturation drop on SpO2
|
3.22 Percentage
Standard Deviation 3.53
|
4.18 Percentage
Standard Deviation 4.02
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=9 participants at risk
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.
|
Group B
n=12 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/9 • One day
1 patient from group B experienced apnea after intubation had been completed.
|
8.3%
1/12 • Number of events 1 • One day
1 patient from group B experienced apnea after intubation had been completed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place