Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults

Noninvasive Ventilation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876873
• Other study ID #: 2012364
• Status: Completed
• Phase: N/A
• Start date: June 9, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: April 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Noninvasive Ventilation

Intervention

Procedure:
• 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).

Device:
• Medline Top Valve Anesthesia Mask
Face mask used per standard of care to provide oxygen to subjects before surgical procedures.

Locations

Country	Name	City	State
United States	University Hospital	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal and average expiratory tidal volume during mask ventilation	Measured in mL	Day 1
Secondary	Maximal and average inspiratory tidal volume during mask ventilation	Measured in mL	Day 1
Secondary	Maximal and average end-tidal CO2 (ETCO2) during mask ventilation	Measured in mm Hg	Day 1
Secondary	Maximal and average airway flow during mask ventilation	Measured in L/min	Day 1
Secondary	Lowest and delta O2 saturation drop on SpO2 during mask ventilation	Measured in %	Day 1
Secondary	Lowest and delta O2 saturation drop on SpO2 during intubation	Measured in %	Day 1