Clinical trial NCT03876873: Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
Official title: A Prospective, Randomized, Non-Blinded, Crossover Controlled Clinical Trial Evaluating the Efficacy of Face Mask Ventilation With 45 Degree Head Rotation in Anesthetized Obese (BMI ≥ 35) Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noninvasive Ventilation
Keywords: Face Mask
Obesity
Anesthetized Adult
Ventilation
Head Rotation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Maximal and Average Expiratory Tidal Volume During Mask Ventilation
timeFrame: Day 1
Secondary outcomes:
measure: Maximal and Average Inspiratory Tidal Volume During Mask Ventilation
timeFrame: Day 1
measure: Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation
timeFrame: Day 1
measure: Maximal and Average Airway Flow During Mask Ventilation
timeFrame: Day 1
measure: Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation
timeFrame: Day 1
measure: Lowest and Delta O2 Saturation Drop on SpO2 During Intubation
timeFrame: Day 1
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Boris Mraovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.