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

NCT03876873 | Completed Results FDA Device

• 1 other identifier: 2012364
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Noninvasive Ventilation

Keywords

Face Mask; Obesity; Anesthetized Adult; Ventilation; Head Rotation

Outcome Measures

Primary Outcomes (1)

• Maximal and Average Expiratory Tidal Volume During Mask Ventilation

  Measured in mL

  Day 1

Secondary Outcomes (5)

• Maximal and Average Inspiratory Tidal Volume During Mask Ventilation

  Day 1

• Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation

  Day 1

• Maximal and Average Airway Flow During Mask Ventilation

  Day 1

• Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation

  Day 1

• Lowest and Delta O2 Saturation Drop on SpO2 During Intubation

  Day 1

Study Arms (2)

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)

Procedure: Head Rotation During Face Mask Ventilation; Device: Medline Top Valve Anesthesia Mask

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)

Procedure: Head Rotation During Face Mask Ventilation; Device: Medline Top Valve Anesthesia Mask

Interventions

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).

Group A; Group B

Medline Top Valve Anesthesia Mask DEVICE

Face mask used per standard of care to provide oxygen to subjects before surgical procedures.

Also known as: Face Mask

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• ASA Physical Status Classification I-III
• Body Mass Index (BMI) ≥ 35 kg/m\^2

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (5)

• 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.

  PMID: 24122033 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.

  PMID: 17065880 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.

  PMID: 19293691 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.

  PMID: 28009638 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.

  PMID: 29155689 BACKGROUND

MeSH Terms

Conditions

Obesity; Respiratory Aspiration

Interventions

Masks

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Boris Mraovic
• Organization: University of Missouri-Columbia

mraovicb@health.missouri.edu

5738822568

Study Officials

• Boris Mraovic, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 15, 2019
• Study Start: June 9, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)