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Completed

NCT Number: NCT03876873

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Medline Top Valve Anesthesia Mask

Device

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

Other names: Face Mask

Primary outcomes

  1. Maximal and Average Expiratory Tidal Volume During Mask Ventilation

    Time frame: Day 1

    Measured in mL

Secondary outcomes

  1. Maximal and Average Inspiratory Tidal Volume During Mask Ventilation

    Time frame: Day 1

    Measured in mL

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

    Time frame: Day 1

    Measured in mm Hg

  3. Maximal and Average Airway Flow During Mask Ventilation

    Time frame: Day 1

    Measured in L/min

  4. Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation

    Time frame: 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).

  5. Lowest and Delta O2 Saturation Drop on SpO2 During Intubation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2019
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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