Uso da terapia de oscilação de alta frequência da parede torácica de lactantes: estudo de viabilidade para um ensaio clínico controlado e randomizado

Abstract

Introduction: During respiratory infections, the body's inflammatory response results in increased production and accumulation of mucus in the respiratory airways. Expector® LAC, a Brazilian device under development that enables the use of HighFrequency Chest Wall Oscillation Therapy, emerges as an option to facilitate mucus removal in infants. Objective: To test the feasibility of high-frequency oscillatory therapy with Expector® in healthy infants. Methods: Feasibility study for a controlled and randomized clinical trial, approved by the Research Ethics Committee of UFRN/FACISA (no. 5,636,504). Initially, a pilot study was conducted with 10 participants to adjust data collection. The sample consisted of 30 participants, aged 3 to 6 months, allocated into 3 groups. The experimental groups used Expector® in different settings, the first with all mini-motors activated and the second with only the 4 upper ones, while the control group had the equipment deactivated. Participants were evaluated before, during, and after its use. Outcomes included heart rate and peripheral oxygen saturation assessed by pulse oximetry; lung auscultation examined with a stethoscope; presence/absence of pain, observed through the Children and Infant’s Postoperative Pain Scale (CHIPPS); infant's sleep/wakefulness state, analyzed by visual observation; and parental satisfaction, measured with a questionnaire developed for this purpose. Data were analyzed using Generalized Estimating Equations. A statistical significance level was considered when p<0.05. Results: A total of 40 infants and their respective caregivers participated in the study, with 10 in the pilot study. After adjustments with the pilot study, 30 participated in the final study (mean age 4.4 ± 0.96 months). GEE indicated that for the outcomes of HR, SpO2, lung auscultation, and pain, there were no differences between the study groups. However, RR, sleep/wakefulness, baby's comfort, and parental comfort showed differences. RR was higher in G2, regardless of time (p = 0.002). Sleep/wakefulness had lower scores after 20 minutes of equipment use, regardless of the group, tending towards a sleepy state during this period (p = 0.04). There was a difference in baby's comfort between times (p = 0.03), with no location of this difference, and parental comfort also showed a difference between times (p = 0.02), being higher at 5 minutes of Expector® use. Conclusion: Expector® LAC is a feasible, comfortable, and safe device for use in infants aged 3 to 6 months, as it does not pose risks of alterations in physiological variables, sleep/wakefulness state, or pain generation.