Noninvasive VentilationNCT03876873
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
A study testing Head Rotation During Face Mask Ventilation and Medline Top Valve Anesthesia Mask in people with Noninvasive Ventilation, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation
- What is being tested?
- Head Rotation During Face Mask Ventilation and Medline Top Valve Anesthesia Mask
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ASA Physical Status Classification I-III
- Body Mass Index (BMI) ≥ 35 kg/m^2
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Noninvasive Ventilation
- Being tested
- Head Rotation During Face Mask Ventilation, Medline Top Valve Anesthesia Mask
- Keywords
- Face Mask, Obesity, Anesthetized Adult, Ventilation, Head Rotation
- Medical subject headings
- Obesity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head Rotation During Face Mask VentilationProcedure or surgery
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 MaskDevice
Also called Face Mask
Face mask used per standard of care to provide oxygen to subjects before surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Head Rotation During Face Mask Ventilation; Device: Medline Top Valve Anesthesia Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal and Average Expiratory Tidal Volume During Mask Ventilation
Measured in mL
Measured: Day 1
Secondary outcomes (5)
Maximal and Average Inspiratory Tidal Volume During Mask Ventilation
Measured in mL
Measured: Day 1
Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation
Measured in mm Hg
Measured: Day 1
Maximal and Average Airway Flow During Mask Ventilation
Measured in L/min
Measured: Day 1
Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation
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).
Measured: Day 1
Lowest and Delta O2 Saturation Drop on SpO2 During Intubation
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start9 Jun 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Mraovic, University of Missouri-Columbia
- Investigators
- Boris Mraovic, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876873
- Sponsor's protocol ID
- 2012364
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2019
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24122033Kheterpal 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.
PubMed 17065880Kheterpal 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.
PubMed 19293691Itagaki 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.
PubMed 28009638Hales 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.
PubMed 29155689
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03876873
- Acronym / sponsor ID
- 2012364
- Conditions
- Noninvasive Ventilation
- Keywords
- Face Mask, Obesity, Anesthetized Adult, Ventilation, Head Rotation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Head Rotation During Face Mask Ventilation, Device: Medline Top Valve Anesthesia MaskHead Rotation During Face Mask Ventilation. Step 1: Neutral Position (1 minute), Step 2: Head Rotation (1 minute), Step 3: Neutral Position (1 minute) |
| Group B | Experimental | Procedure: Head Rotation During Face Mask Ventilation, Device: Medline Top Valve Anesthesia MaskHead Rotation During Face Mask Ventilation. Step 1: Head Rotation (1 Minute), Step 2: Neutral Position (1 minute), Step 3, Head Rotation (1 Minute) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- ASA Physical Status Classification I-III
- Body Mass Index (BMI) ≥ 35 kg/m^2
Key exclusion criteria (7 listed)
- Inability to obtain written informed consent
- Pregnant or breastfeeding
- Limited head rotation or neck extension
- Subjects with expected or history difficult intubation
- Large beard
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head Rotation During Face Mask VentilationParticipants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle). | Procedure or surgery | Group A, Group B |
| Medline Top Valve Anesthesia MaskAlso: Face MaskFace mask used per standard of care to provide oxygen to subjects before surgical procedures. | Device | Group A, Group B |
Primary outcome
Maximal and Average Expiratory Tidal Volume During Mask Ventilation
Time frame: Day 1
Measured in mL
5 secondary outcomes
Maximal and Average Inspiratory Tidal Volume During Mask Ventilation
Time frame: Day 1
Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation
Time frame: Day 1
Maximal and Average Airway Flow During Mask Ventilation
Time frame: Day 1
Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation
Time frame: Day 1
Lowest and Delta O2 Saturation Drop on SpO2 During Intubation
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24122033Langeron 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.
- Background: PubMed 17065880Kheterpal 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.
- Background: PubMed 19293691Kheterpal 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.
- Background: PubMed 28009638Itagaki 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.
- Background: PubMed 29155689Hales 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Mraovic, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head Rotation During Face Mask Ventilation and Medline Top Valve Anesthesia Mask in people with Noninvasive Ventilation, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal and Average Expiratory Tidal Volume During Mask Ventilation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876873, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.