Comparison of the Classic Face Mask Versus NuMask for Preoxygenation

• ClinicalTrials.gov Identifier: NCT01865851
• Recruitment Status: Unknown
• First Posted: May 31, 2013
• Last Update Posted: September 14, 2017
• Sponsor: Nimmagadda, Usharani, M.D.
• Information provided by (Responsible Party): Usharani Nimmagadda, Advocate Illinois Masonic Medical Center

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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Comparison of the Classic Face Mask Versus NuMask for Preoxygenation
• Study Start Date: May 2013
• Estimated Primary Completion Date: May 2018
• Estimated Study Completion Date: June 2018

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Inspired (FIO2) [ Time Frame: 30 minutes ]
   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 :

1. ETCO2 [ Time Frame: 30 minutes ]
2. ETO2 [ Time Frame: 30 minutres ]
3. Respiratory Rate [ Time Frame: 30 minutes ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• volunteers

Exclusion Criteria:

• under 18

Contacts and Locations

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 of Results:

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.

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.

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.

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.

• Responsible Party: Usharani Nimmagadda, Anesthesiologist, Advocate Illinois Masonic Medical Center
• ClinicalTrials.gov Identifier: NCT01865851 History of Changes
• Other Study ID Numbers: IRB5558
• First Posted: May 31, 2013
• Last Update Posted: September 14, 2017
• Last Verified: September 2017

Keywords provided by Usharani Nimmagadda, Advocate Illinois Masonic Medical Center:

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; Pathologic Processes