Schwarz Ch, Cirugeda-Kühnert M, Hagen R
Klinik für Hals-Nasen-Ohrenheilkunde, Plastische Operationen, Katharinenhospital Stuttgart.
Laryngorhinootologie. 2004 Mar;83(3):173-9. doi: 10.1055/s-2004-814266.
Tracheostoma valves for laryngectomized patients were introduced to enable the laryngectomee after successful surgical voice restoration either by a voice prosthesis, a surgical shunt or microvascular laryngoplasty, to speak without using his fingers to close the tracheostoma. The basic principle of these aids is a mobile valve, which closes automatically at a certain air flow, directing the expired air of the lungs into the pharynx. In spite of the clear advantage of enabling a hands-free speech, the long term acceptance rate is still rather low, which is mainly caused by problems of an airtight fixation within or at the tracheostoma. Another important disadvantage of these tracheostoma valves is the necessity of removing the valve during coughing. The new tracheostoma valve "Window" (ADEVA Company, Lübeck, Germany) offers a clear improvement regarding this point. It is constructed with an additional coughing lid, which opens at a certain airflow and closes automatically after the coughing attack. After successful development and clinical testing of the new aid in 1999 and 2000, it was now the question, if the previously low acceptance rate of tracheostoma valves could be improved in the long term use by this new type of valve.
Within the last 4 years 70 patients were provided with the "Window" tracheostoma valve. Patients were followed up at regular intervals in order to evaluate the function, the acceptance and the durability of the new device. Additional to the clinical examination patients had to fill in a questionnaire in order to investigate the subjective estimation by each patient himself. 15 patients did not send back their questionnaire or did not fill it in correctly, 5 patients refused clinical supervision after adjustment of the device, so finally the long term use in 50 patients could be analysed.
82 % of the patients reported, that the coughing lid worked safely and opened immediately during the coughing attack. Most of the patients were satisfied with their device, but had nevertheless some proposals for a further improvement: although they cover the tracheostoma either with their clothes or a protection scarf, most of the patients would prefer a device which is smaller than the current model. Some patients reported on an insufficient stability of the plastic material, which led to a defect at the sliding mechanism of the coughing lid. The greatest problem regarding the regular use of the valve was - comparable to conventional tracheostoma valves - the occurrence of an air leakage around the tracheostoma. Although there are three different models of the "Window" tracheostoma valve available, only patients being fitted with the "standard-T-type" version could wear the device 10 hours a day or longer without any problems of air leakage.
The "Window" tracheostoma valve with an integrated coughing lid provides further improvement in speech rehabilitation of laryngectomees. The actual rate of acceptance of 62 % for all "Window" patients (1 month daily use for at least 2 hours) is superior to other reports on the use of tracheostoma valves and probably caused by the additional comfort provided by the coughing lid. Another important factor for the long term use of tracheostoma valves is however the safe fixation of the device in or around the tracheostoma. In this point further improvement is necessary, as only the model with the fixation within the trachea (T-type) led to a satisfactory long term airtight fixation.
为喉切除患者引入气管造口瓣膜，目的是使喉切除患者在通过语音假体、手术分流或微血管喉成形术成功实现手术语音恢复后，无需用手指关闭气管造口就能说话。这些辅助装置的基本原理是一个可移动的瓣膜，它在一定气流下自动关闭，将肺部呼出的空气导入咽部。尽管免提说话具有明显优势，但长期接受率仍然相当低，这主要是由气管造口内或气管造口处气密固定的问题导致的。这些气管造口瓣膜的另一个重要缺点是咳嗽时需要取下瓣膜。新型气管造口瓣膜“窗口”（德国吕贝克的ADEVA公司）在这一点上有明显改进。它配有一个额外的咳嗽盖，在一定气流下打开，咳嗽发作后自动关闭。在1999年和2000年对这种新型辅助装置进行成功研发和临床测试后，现在的问题是，这种新型瓣膜能否在长期使用中提高气管造口瓣膜先前较低的接受率。
在过去4年里，70名患者使用了“窗口”气管造口瓣膜。定期对患者进行随访，以评估这种新装置的功能、接受程度和耐用性。除了临床检查外，患者还必须填写一份问卷，以调查每位患者自己的主观评价。15名患者未寄回问卷或填写不正确，5名患者在装置调整后拒绝临床监督，因此最终可以对50名患者长期使用该装置的情况进行分析。
82%的患者报告说，咳嗽盖工作安全，并在咳嗽发作时立即打开。大多数患者对他们的装置感到满意，但仍有一些进一步改进的建议：尽管他们用衣服或防护围巾覆盖气管造口，但大多数患者更喜欢比当前型号更小的装置。一些患者报告说塑料材料稳定性不足，导致咳嗽盖滑动机制出现故障。与传统气管造口瓣膜类似，瓣膜常规使用中最大的问题是气管造口周围出现漏气。尽管有三种不同型号的“窗口”气管造口瓣膜可供选择，但只有安装“标准T型”版本的患者才能每天佩戴该装置10小时或更长时间而无任何漏气问题。
带有集成咳嗽盖的“窗口”气管造口瓣膜在喉切除患者的语音康复方面有进一步改进。所有“窗口”患者（每天使用至少2小时，持续1个月）的实际接受率为62%，高于其他关于气管造口瓣膜使用的报告，这可能是由于咳嗽盖提供了额外的舒适度。然而，气管造口瓣膜长期使用的另一个重要因素是装置在气管造口内或周围的安全固定。在这一点上还需要进一步改进，因为只有气管内固定（T型）型号才能实现令人满意的长期气密固定。
