Abstract -

University of Miami:

Evaluation of the Wright Humidification Mask in Chronic Tracheostomy Patients.

Enisa Carvalho MD, Nicolas Crescimone MD, Claudia Fernandez MD,
Yadelis Giguel MD, Keith A. Candiotti MD

University of Miami, Department of Anesthesiology, Division of Clinical Research

ABSTRACT
Background: Tracheotomy patients require the use of hot or cold humidifying devices and/or heat moisture exchangers 1-3 on a regular basis, several times a day, even in very damp climates in order to maintain the health of airway mucosal and tissue 4. Due to the treatment time involved for separate moisturization treatments for both the trach stoma (lower airway) and the nose and mouth (upper airway and sinuses) patient compliance is often poor. The objective of this study is to evaluate the efficacy and feasibility of a new custom-designed, connected face and tracheotomy mask (Wright System Mask), developed to increase the ease and shorten the time required for humidification.

Methods: The study was IRB approve and all patients signed informed consent. This pilot, randomized controlled clinical trial enrolled patients with existing tracheotomies. Patients who were unable to tolerate room air or maintain adequate saturation (>90%); had recent episodes of asthma or decompensate COPD or were pregnant were excluded. Humidification was performed with normal saline and compressed air.   Blood O2% saturation was measured at 4 different time points involving 3 different masks: 1) Baseline-room air with no mask or humidification; 2) Patients using a conventional facemask only; 3) Patients using a trach-collar and 4) Patients using a Wright System Mask. The order of mask type was randomized. At the end of the study patients were given a survey to evaluate the mask in terms of ease of use, comfort and breathing quality. 

Results:  Mean age was 61 ± 5 years (range, 52 to 69) with 9 males and 1 female enrolled. Average room air baseline saturation was 98.80% ± 1.26. The mean saturation for the conventional facemask was 98.93% ± 1.23; trach-collar 98.89% ± 1.23 and Wright System Mask 99.07% ± 1.24 (p=NS).  The ease of device use (1-10, easiest) was 8.8 ± 1.4 for the facemask, 9.3 ± 0.9 for the trach-collar and 8.5 ± 1.6 for the Wright System Mask (p=NS). Comfort ratings (1-10, most comfortable) were noted as: facemask 7.5 ± 1.5; trach-collar 8.6 ± 1.6 and the Wright System Mask 7 ± 1.7 (p=NS). Difficulty of breathing (1-10, easiest) was 9 ± 2; 9.2 ± 1.4; 8.6 ± 1.7 for the conventional facemask, trach-collar and Wright System Mask respectively (p=NS).

Conclusions: Negative patient compliance for regular and frequent airway humidification following tracheostomy is widely recognized as leading to multiple complications such as mucus plugs and infections, etc.  The Wright System Mask, combining simultaneous humidification of both upper and lower airways, is likely to become a preferred airway moisturization method due to its time efficiency and comfort. No differences were noted in blood O2%, comfort, ease of use or ease of breathing with the Wright System Mask compared to conventional face or trach masks.

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