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Comparison of the Classic Face Mask Versus NuMask for Preoxygenation

Primary Purpose

Inspired Oxygen (FIO2), End-tidal Oxygen (ETO2), End-tidal Carbon Dioxide (ETCO2) and Respiratory Rate (RR) Will be Measured Every 30 Seconds

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Classic Face Mask and NuMask
Sponsored by
Nimmagadda, Usharani, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inspired Oxygen (FIO2), End-tidal Oxygen (ETO2), End-tidal Carbon Dioxide (ETCO2) and Respiratory Rate (RR) Will be Measured Every 30 Seconds focused on measuring Inspired oxygen, end-tidal oxygen, end-tidal carbon dioxide, respiratory rate, preoxygenation, classic face mask, NuMask

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • volunteers

Exclusion Criteria:

  • under 18

Sites / Locations

  • Advocate Illinois Masonic Medical Center, Department of AnesthesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Start with Classic Face Mask Group

Start with NuMask Group

Arm Description

The volunteers will be asked to breathe normally (Tidal Volume Breathing) through face mask for 5 minutes. After 5 minutes, the volunteers will be asked to breathe room air for 5 minutes and then breathe through a NuMask for 5 minutes. This will be followed by room air breathing for 5 minutes. At the end of the 5 minutes of room air breathing, the same volunteers will be asked to breathe through the face mask for 5 minutes.

The volunteers will be asked to breathe through the NuMask for 5 minutes, followed by room air breathing for 5 minutes, then 5 minutes of breathing through the face mask. This will be followed by room air breathing for 5 minutes and then 5 minutes of NuMask breathing.

Outcomes

Primary Outcome Measures

Inspired (FIO2)
Healthy volunteers will be randomly breathing 100% oxygen through either a classic face mask or NuMask for 5 minutes. Measurements will be taken every 30 seconds. The purpose of the study is to evaluate which mask will provide maximal pre-oxygenation (more than 90% end-tidal oxygen).

Secondary Outcome Measures

ETCO2
ETO2
Respiratory Rate

Full Information

First Posted
May 14, 2013
Last Updated
September 13, 2017
Sponsor
Nimmagadda, Usharani, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01865851
Brief Title
Comparison of the Classic Face Mask Versus NuMask for Preoxygenation
Official Title
Comparison of the Classic Face Mask Versus NuMask for Preoxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nimmagadda, Usharani, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently used face mask has certain disadvantages; such as, not providing a complete seal in certain patients, causing hand fatigue after holding the mask in place for more than a few minutes, causing claustrophobia in an occasional patient, the need to hold the mask from head of the bed, and possible worsening of the trauma in patients with facial injuries, and the need to use different size masks in different patients. The NuMask overcomes all of these disadvantages and does benefit the patients.
Detailed Description
The administration of oxygen before anesthetic induction and tracheal intubation (preoxygenation) is a well-recognized technique designed to increase oxygen reserves and thereby delay the onset of arterial oxygen desaturation during apnea. It is particularly important if manual ventilation is not desirable prior to intubation (eg: rapid sequence induction) or if difficulty with ventilation or intubation is anticipated or in patients with oxygen transport limitations. Because the "cannot ventilate/cannot intubate" situation is an unpredictable event, theoretically all patients should be maximally preoxygenated. Fraction of inspired oxygen (FIO2) is one of the factors in achieving maximal preoxygenation. A common reason for the failure to achieve an FIO2 close to 1.0 is a leak under the face mask. Several factors may contribute to the leak. These are edentulous patients, patients with sunken cheeks, bearded patients, the presence of nasogastric tubes, wrong size face masks, improper use of head straps, and patients with large heads and faces where even the large size mask may not fit properly. Recently a new intraoral mask "NuMask" has become available for anesthetic induction. It is placed under the lips and outside the gums of the patient mouth (similar to snorkel mouth piece), thus providing a good seal in almost any patient. In addition to providing a good seal, the NuMask has other advantages over the standard face mask. It has very small dead space (18 cc : 110 cc), provides comfortable grip, ventilation can be provided from any position and causes less facial trauma. The efficacy of preoxygenation using the NuMask will be compared to the classic face mask in approximately 30 healthy and consenting adult volunteers. All of the volunteers will be randomly assigned into one of 2 groups. All volunteers will be tested for three (3) periods of 5 minute intervals. Inspired oxygen (FIO2), end-tidal oxygen (ETO2), end-tidal carbon dioxide (ETCO2) and respiratory rate (RR) will be tested. Analysis of the data may reveal whether the NuMask is equal, superior, or inferior to the classic face mask in achieving maximal preoxygenation. Although the NuMask has been tested and used in various scenarios of airway management, its efficacy in achieving maximal preoxygenation has not been studied

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inspired Oxygen (FIO2), End-tidal Oxygen (ETO2), End-tidal Carbon Dioxide (ETCO2) and Respiratory Rate (RR) Will be Measured Every 30 Seconds
Keywords
Inspired oxygen, end-tidal oxygen, end-tidal carbon dioxide, respiratory rate, preoxygenation, classic face mask, NuMask

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Start with Classic Face Mask Group
Arm Type
Active Comparator
Arm Description
The volunteers will be asked to breathe normally (Tidal Volume Breathing) through face mask for 5 minutes. After 5 minutes, the volunteers will be asked to breathe room air for 5 minutes and then breathe through a NuMask for 5 minutes. This will be followed by room air breathing for 5 minutes. At the end of the 5 minutes of room air breathing, the same volunteers will be asked to breathe through the face mask for 5 minutes.
Arm Title
Start with NuMask Group
Arm Type
Active Comparator
Arm Description
The volunteers will be asked to breathe through the NuMask for 5 minutes, followed by room air breathing for 5 minutes, then 5 minutes of breathing through the face mask. This will be followed by room air breathing for 5 minutes and then 5 minutes of NuMask breathing.
Intervention Type
Device
Intervention Name(s)
Classic Face Mask and NuMask
Primary Outcome Measure Information:
Title
Inspired (FIO2)
Description
Healthy volunteers will be randomly breathing 100% oxygen through either a classic face mask or NuMask for 5 minutes. Measurements will be taken every 30 seconds. The purpose of the study is to evaluate which mask will provide maximal pre-oxygenation (more than 90% end-tidal oxygen).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
ETCO2
Time Frame
30 minutes
Title
ETO2
Time Frame
30 minutres
Title
Respiratory Rate
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: volunteers Exclusion Criteria: under 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usharani Nimmagadda, MD
Phone
312-240-1020
Email
ushanimm@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
M. Ramez Salem, MD
Phone
773-296-7034
Email
mrsalem@sbcglobal.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Knezevic, PhD, MD
Organizational Affiliation
Advocate Illinois Masonic Medical Center, Department of Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Advocate Illinois Masonic Medical Center, Department of Anesthesia
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usharani Nimmagadda, MD
Phone
773-296-5403
Email
ushanimm@hotmail.com
First Name & Middle Initial & Last Name & Degree
Adriana S Vonderhaar, BS
Phone
773-296-5616
Email
adriana.vonderhaar@advocatehealth.com
First Name & Middle Initial & Last Name & Degree
Ushrani Nimmagadda, MD
First Name & Middle Initial & Last Name & Degree
M. Ramez Salem, MD
First Name & Middle Initial & Last Name & Degree
Maunak Rana, MD
First Name & Middle Initial & Last Name & Degree
Nick Knezevic, PhD, MD
First Name & Middle Initial & Last Name & Degree
Ruben Sauer, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17541073
Citation
Nimmagadda U, Salem MR, Joseph NJ, Miko I. Efficacy of preoxygenation using tidal volume and deep breathing techniques with and without prior maximal exhalation. Can J Anaesth. 2007 Jun;54(6):448-52. doi: 10.1007/BF03022030.
Results Reference
result
PubMed Identifier
11323373
Citation
Nimmagadda U, Chiravuri SD, Salem MR, Joseph NJ, Wafai Y, Crystal GJ, El-Orbany MI. Preoxygenation with tidal volume and deep breathing techniques: the impact of duration of breathing and fresh gas flow. Anesth Analg. 2001 May;92(5):1337-41. doi: 10.1097/00000539-200105000-00049.
Results Reference
result
PubMed Identifier
10969302
Citation
Nimmagadda U, Salem MR, Joseph NJ, Lopez G, Megally M, Lang DJ, Wafai Y. Efficacy of preoxygenation with tidal volume breathing. Comparison of breathing systems. Anesthesiology. 2000 Sep;93(3):693-8. doi: 10.1097/00000542-200009000-00018.
Results Reference
result
PubMed Identifier
10839945
Citation
Ramez Salem M, Joseph NJ, Crystal GJ, Nimmagadda U, Benumof JL, Baraka A. Preoxygenation: comparison of maximal breathing and tidal volume techniques. Anesthesiology. 2000 Jun;92(6):1845-7. No abstract available.
Results Reference
result

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Comparison of the Classic Face Mask Versus NuMask for Preoxygenation

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