Domiciliary experience of the Target Inhalation Mode (TIM) breathing maneuver in patients with cystic fibrosis

Abstract

Background: The time requirements for multiple daily nebulizer treatments are important impediments to the quality of life for most patients with cystic fibrosis (CF). The I-neb Adaptive Aerosol Delivery (AAD) System can be used with a new mode of breathing during inhalation of aerosol, the Target Inhalation Mode (TIM). As a function of the TIM algorithm, the patient is guided to a slow and deep inhalation, which can result in shorter treatment times.

Methods: This study was conducted as a 3-month patient handling study of the I-neb AAD System in 42 patients with CF aged 12-57 years. The I-neb AAD System was supplied in both the standard Tidal Breathing Mode (TBM), and in TIM. Patients were trained to use the I-neb AAD System in TIM for the delivery of all their inhaled medications, but if they were not comfortable with the TIM maneuver they could change to the TBM maneuver. The primary variables were compliance with the correct use of the I-neb AAD System, and treatment times. The secondary variables were based on study questionnaires at the end of the study and covered ease of use, patient confidence, and patient satisfaction with the I-neb AAD System.

Results: There were a total of 10,240 complete treatments and of these, 8979 (88%) were in TIM. Compliance with the correct use of the I-neb AAD System was 97.6%. The mean treatment time for complete treatments in TIM was 4.20 min, compared with 6.83 min when using the I-neb AAD System in TBM. The responses to the questionnaires indicated that over 77% of the patients found the I-neb AAD System in TIM to be either: very easy, easy, or acceptable to use.

Conclusions: The results demonstrated that by using the I-neb AAD System in TIM, a 40-50% reduction of nebulizer treatment times, and a high level of compliance could be achieved. The results also showed that the patients found the I-neb AAD System easy to use.

FIG. 1.

The I-neb Adaptive Aerosol Delivery (AAD) System. The main components of the device are the mouthpiece, the medication chamber assembly, and the body. The I-neb AAD System has been designed to deliver aerosol with two different breathing pattern algorithms: the Tidal Breathing Mode (TBM) and the Target Inhalation Mode (TIM). In TIM the inspiratory flow through the valve in the mouthpiece is limited to ∼20 L/min.

FIG. 2.

Graphical presentation of the two breathing patterns used with the I-neb AAD System. The first part of the graph shows the patient's tidal breathing when using the I-neb AAD System in Tidal Breathing Mode (TBM). The second, third, and last parts of the graph show the process to extend the patient's slow and deep inhalations from a 3-sec inhalation (2-sec aerosol pulse) to an 8-sec inhalation (7-sec aerosol pulse) when using the I-neb AAD System in Target Inhalation Mode (TIM).

FIG. 3.

The histogram presents the treatment times analyzed separately in 2-min increments. For this purpose the treatment time data was divided into three groups: Target Inhalation Mode (TIM) treatment times belonging to patients with less than 5% of treatments taken in Tidal Breathing Mode (TBM), treatment times for the remaining TIM treatments, and treatment times for TBM treatments.

FIG. 4.

An analysis of the final aerosol pulse times in Target Inhalation Mode (TIM) for the last treatment per patient indicated that >80% of the patients were able to extend the TIM inhalation time above the initial 2-sec inhalation time, that 50% were able to extend the inhalation time up to and above 5 sec, and that 17% were able to reach the upper limit of 8 sec.