Associate Department of Anaesthesia and Perioperative Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Department of Otolaryngology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3008-3014. doi: 10.1053/j.jvca.2022.02.004. Epub 2022 Feb 12.
Tracheal stenosis is a debilitating condition that often presents as an emergency and is challenging to treat. Dilatation may avoid tracheostomy or costly tracheal resection and reconstruction. Traditional dilators cause complete occlusion, preventing oxygenation and ventilation, limiting the safe duration of dilatation, and increasing the risk of hypoxic injury or barotrauma. The study authors here assessed an innovative nonocclusive tracheal dilatation balloon, which may improve patient safety by allowing continuous gas exchange.
A prospective observational study of 20 discrete dilatation procedures performed in 13 patients under general anesthesia. The primary outcomes were the ability to ventilate during dilatation and the preservation of peripheral oxygen saturation. Secondary outcomes included a measured reduction in stenosis, improvement in Cotton-Myer grading, and procedure-related adverse events.
At a single university (academic) hospital.
Consenting adult patients with acquired tracheal stenosis.
Access to the airway was maintained by a rigid bronchoscope or supraglottic airway device, as deemed appropriate. Continuous conventional ventilation was provided during 3-minute balloon dilatations.
Heart rate, airway pressure, end-tidal carbon dioxide partial pressure, and peripheral oxygen saturation were measured, and adverse events were recorded. Ventilation was satisfactory in all patients. Peripheral saturation remained greater than 94% in 19 of the 20 (95%) procedures. Stenosis internal diameter and grading were improved. Two patients had minor reversible adverse events (coughing and laryngospasm), which did not prevent completion of the procedure.
The authors report the first human trial of the device, in which continuous conventional ventilation could be provided during all tracheal balloon dilatation procedures. Larger trials are needed to confirm improved patient safety and comparative efficacy.
气管狭窄是一种使人虚弱的疾病，常表现为急症，且难以治疗。扩张术可避免气管切开术或昂贵的气管切除和重建。传统的扩张器会导致完全阻塞，阻止氧气供应和通气，限制扩张的安全持续时间，并增加缺氧损伤或气压伤的风险。本研究作者评估了一种创新的非闭塞性气管扩张球囊，它可以通过允许持续气体交换来提高患者安全性。
对 13 名全麻下接受 20 次离散扩张术的患者进行前瞻性观察研究。主要结局是在扩张过程中通气的能力和外周血氧饱和度的保持。次要结局包括测量狭窄程度的降低、Cotton-Myer 分级的改善以及与操作相关的不良事件。
在一家大学（学术）医院。
同意的成年获得性气管狭窄患者。
根据需要，通过刚性支气管镜或声门上气道装置维持气道进入。在 3 分钟的球囊扩张过程中持续提供常规通气。
测量心率、气道压力、呼气末二氧化碳分压和外周血氧饱和度，并记录不良事件。所有患者的通气均令人满意。在 20 次（95%）操作中的 19 次，外周饱和度保持在 94%以上。狭窄的内径和分级得到改善。两名患者出现轻微的可逆不良事件（咳嗽和喉痉挛），但不影响手术完成。
作者报告了该设备的首次人体试验，在所有气管球囊扩张过程中都可以提供持续的常规通气。需要更大的试验来证实改善的患者安全性和比较疗效。
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