| Objective:Obstructive sleep apnea hypopnea syndrom (OSAHS) is the most common sleep disorder. OSAHS’s treatments include oral appliances, continuous positive airway pressure (CPAP), Provent nasal paste, surgical treatment, and so on. Oral appliances are mainly used in simple snoring and patients with mild and moderate OSAHS, especially in patients with mandibular retraction. Oral appliances can also be used in patients who could not tolerate CPAP and surgical treatment, but the validity can’t be sure. UPPP and H-UPPP are the most commonly used surgical approaches in patients with upper airway obstruction and AHI<20times per hour. However, the surgery can only partially solve the obstruction caused by soft palate and soft tissue, and the total effective rate is less than50%. The operation has the shortcomings of easy relapse, large injury and high cost. CPAP as the first-line treatment of OSAHS which can provide a physiological pressure support on the upper airway and keep the upper airway open during sleep. But it is too expensive to use widelyand too big to carry portablly; the continuous flow leads to discomfort that patients could not tolerated. In order to make up for the disadvantage of existing therapeutic approaches, we design and make positive pressure mask and rhinobyon to treat OSAHS based the theory of EPAP. We aim to verify the safety, evaluate the efficacy and tolerability through this experiment.Methods:We make positive pressure rhinobyon used3D printing technology. To assess the safety of positive pressure mask:1, measure partial pressure of CO2in exhaled air by electrocardiograph monitor;2, measure inspiratory resistance by glass-U-tube manometer when use positive pressure mask. To evaluate the effectiveness of using positive pressure mask and positive pressure mask rhinobyon:The selected patients were randomly divided into A group and B group, self crossover control trial was used. The test is divided into two stages. First stage, patients in A group use CPAP treatment, patients in B group use positive pressure mask/rhinobyon. After one week treatment and one week of elution time, exchange treatments to treat another week, Patients were asked to fill out the Epworth Sleeping Scale before PSG and after treatments of positive pressure mask and CPAP.2, We measured AHI, the lowest SaO2and mean SaO2by PSG before and after the treatment using positive pressure mask to evaluate the efficacy.3, Parameters such as AHI, the lowest SaO2and mean SaO2by PSG were compared between positive pressure mask treatment and CPAP treatment.4, Parameters such as AHI, the lowest SaO2and mean SaO2by PSG were compared between positive pressure rhinobyon treatment and CPAP treatment.Results:1, When EPAP we set is5cmH2O, Partial pressure of CO2is34.5±2.2cmH2O when patients use positive pressure mask; when EPAP is8cmH20, Partial pressure of CO2is33.8±3.8cmH2O; When EPAP is10cmH20, partial pressure of CO2is32.8±2.7cmH20; There is no statistical difference between patients who use CPAP treatment and patients who use positive pressure mask.2, Inspiratory resistance is0.2cmH20when used ventilation mask.3, In patients of A group, the ESS score was12.2±3.91before treatment,5.25±1.65after CPAP treatment and5.80±1.36after mask treatment. In patients of B group, the ESS score was15.4±3.49before treatment,6.00±1.65after CPAP treatment and6.2±2.07after mask treatment. There is statistically significant difference before and after treatment. But there is no statistically significant difference between CPAP and mask treatment.4, A group:Before treatment, AHI is25.6±2.1events/hr, the lowest SaO2is (69.4±5.1)%, mean SaO2is (87.4±4.9)%; After CPAP treatment, AHI is3.5±2.2events/hr, the lowest SaO2is (90.8±3.9)%, mean SaO2is (94.2±3.9)%; After mask treatment, AHI is4.1±2.8events/hr, the lowest SaO2is (90.2±4.9)%, mean SaO2is (93.7±5.9)%. B group:Before treatment, AHI is27.5±2.5events/hr, the lowest SaO2is (67.2±4.3)%, mean SaO2is (85.8±5.4)%; after mask treatment, AHI is4.8±2.1events/hr, the lowest SaO2is (89.5±5.3)%, mean SaO2is (93.9±3.1)%; After CPAP treatment, AHI is2.8±3.5events/hr, the lowest SaO2is (91.4±5.1)%, mean SaO2is (95.1±5.1)%. there is statistically significant difference before and after treatment. But there is no statistically significant difference between CPAP and mask treatment.5, A group:Before treatment, AHI is29.6±4.4events/hr, the lowest SaO2is (62.1±5.2)%, mean SaO2is (85.4±4.9)%; After CPAP treatment, AHI is4.5±2.3events/hr, the lowest SaO2is (91.8±4.7)%, mean SaO2is (92.6±3.4)%; after rhinobyon treatment, AHI is5.1±4.3events/hr, the lowest SaO2is (89.9±6.4)%, mean SaO2is (91.8±5.9)%. B group:Before treatment, AHI is30.3±3.5events/hr, the lowest SaO2is (64.2±5.8)%, mean SaO2is (84.3±5.3)%; After rhinobyon treatment, AHI is4.8±2.1events/hr, the lowest SaO2is (89.5±5.3)%, mean SaO2is (93.9±3.1)%; After CPAP treatment, AHI is4.8±2.8events/hr, the lowest SaO2is (90.6±5.6)%, mean SaO2is (93.1±5.1)%. There is statistically significant difference before and after treatment. But there is not statistically significant difference between CPAP and mask treatment.Conclusion:1, Partial pressure of CO2in exhaled air is of no statistically significant difference between using mask or CPAP. Therefore using mask will not lead to CO2retention. When using mask, the inhaled pressure is0.2cmH2O. Thus using mask will not result in asphyxia. This mask is safe and reliable.2, After patients treated with mask and rhinobyon, ESS scale, AHI, lowest SaO2and mean SaO2improved obviously. There is no statistically significant difference between using mask and CPAP, using rhinobyon and CPAP, respectively. The effect is remarkable when using ventilation mask and using ventilation rhinobyon. |
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