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Trial record 1 of 2 for:    29155689 [PUBMED-IDS]
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Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults

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ClinicalTrials.gov Identifier: NCT03876873
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Boris Mraovic, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Noninvasive Ventilation Procedure: Head Rotation During Face Mask Ventilation Device: Medline Top Valve Anesthesia Mask Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: 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)
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.
Other Name: Face Mask

Experimental: 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)
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.
Other Name: Face Mask




Primary Outcome Measures :
  1. Maximal and average expiratory tidal volume during mask ventilation [ Time Frame: Day 1 ]
    Measured in mL


Secondary Outcome Measures :
  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 %

  5. Lowest and delta O2 saturation drop on SpO2 during intubation [ Time Frame: Day 1 ]
    Measured in %



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876873


Contacts
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Contact: Boris Mraovic, MD 573-882-2568 mraovicb@health.missouri.edu
Contact: Noah Timko, BS, BHS 573-882-2568 timkon@health.missouri.edu

Locations
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United States, Missouri
University Hospital Recruiting
Columbia, Missouri, United States, 65212
Contact: Boris Mraovic, MD    573-882-2568    mraovicb@health.missouri.edu   
Contact: Noah Timko, BS, BHS    573-882-2568    timkon@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Boris Mraovic, MD University of Missouri-Columbia

Publications:
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Responsible Party: Boris Mraovic, Associate Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03876873     History of Changes
Other Study ID Numbers: IRB # 2012364
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Boris Mraovic, University of Missouri-Columbia:
Face Mask
Obesity
Anesthetized Adult
Ventilation
Head Rotation
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs