Comparison of the Classic Face Mask Versus NuMask for Preoxygenation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Nimmagadda, Usharani, M.D.
Sponsor:
Information provided by (Responsible Party):
Usharani Nimmagadda, Advocate Illinois Masonic Medical Center
ClinicalTrials.gov Identifier:
NCT01865851
First received: May 14, 2013
Last updated: May 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Inspired Oxygen (FIO2), End-tidal Oxygen (ETO2), End-tidal Carbon Dioxide (ETCO2)and Respiratory Rate (RR) Will be Measured Every 30 Seconds.
Device: Classic Face Mask and NuMask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparison of the Classic Face Mask Versus NuMask for Preoxygenation

Resource links provided by NLM:


Further study details as provided by Nimmagadda, Usharani, M.D.:

Primary Outcome Measures:
  • Inspired (FIO2) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • ETO2 [ Time Frame: 30 minutres ] [ Designated as safety issue: No ]
  • Respiratory Rate [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Start with Classic Face Mask Group
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.
Device: Classic Face Mask and NuMask
Active Comparator: Start with NuMask Group
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.
Device: Classic Face Mask and NuMask

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • volunteers

Exclusion Criteria:

  • under 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865851

Contacts
Contact: Usharani Nimmagadda, MD 312-240-1020 ushanimm@hotmail.com
Contact: M. Ramez Salem, MD 773-296-7034 mrsalem@sbcglobal.net

Locations
United States, Illinois
Advocate Illinois Masonic Medical Center, Department of Anesthesia Recruiting
Chicago, Illinois, United States, 60657
Contact: Usharani Nimmagadda, MD    773-296-5403    ushanimm@hotmail.com   
Contact: Adriana S Vonderhaar, BS    773-296-5616    adriana.vonderhaar@advocatehealth.com   
Principal Investigator: Ushrani Nimmagadda, MD         
Sub-Investigator: M. Ramez Salem, MD         
Sub-Investigator: Maunak Rana, MD         
Sub-Investigator: Nick Knezevic, PhD, MD         
Sub-Investigator: Ruben Sauer, MD         
Sponsors and Collaborators
Nimmagadda, Usharani, M.D.
Investigators
Study Director: Nick Knezevic, PhD, MD Advocate Illinois Masonic Medical Center, Department of Anesthesiology
  More Information

Publications:
Responsible Party: Usharani Nimmagadda, Anesthesiologist, Advocate Illinois Masonic Medical Center
ClinicalTrials.gov Identifier: NCT01865851     History of Changes
Other Study ID Numbers: IRB5558
Study First Received: May 14, 2013
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nimmagadda, Usharani, M.D.:
Inspired oxygen
end-tidal oxygen
end-tidal carbon dioxide
respiratory rate
preoxygenation
classic face mask
NuMask

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014