Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE

口腔吸痰干预可减少误吸和呼吸机事件：NO-ASPIRATE

• 批准号: 8651049
• 负责人: Mary Lou Sole
• 金额: $ 56.93万
• 依托单位: UNIVERSITY OF CENTRAL FLORIDA
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-10 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8651049
• 关键词: 18 year old; Address; Algorithms; Antisepsis; Aspirate substance; Bacteria; Beds; Biological Markers; Breathing; Caring; Centers for Disease Control and Prevention (U.S.); Clinical Trials Design; Critical Illness; Data; Data Analyses; Development; Discipline of Nursing; Enrollment; Enteral Feeding; Environmental air flow; Equation; Event; Excision; Extravasation; Frequencies; Goals; Guidelines; Head; Health; Healthcare; Hospitals; Hour; Infection; Intensive Care Units; Intervention; Intubation; Lead; Length of Stay; Logistic Regressions; Lung; Mechanical Ventilators; Mechanical ventilation; Methods; Nurses; Oral; Oral cavity; Oropharyngeal; Outcome; Patient Care; Patients; Pneumonia; Prevention; Prevention Protocols; Procedures; Protocols documentation; Randomized; Reflux; Research Personnel; Resources; Risk; Sample Size; Sampling; Secondary to; Single-Blind Study; Specimen; Stomach; Suction; Survival Analysis; Testing; Time; Tube; Ventilator; Work; alpha-amylase; base; cost; disorder prevention; endotracheal; evidence base; glottis; high risk; improved; innovation; lung injury; member; mortality; neglect; nursing intervention; pressure; prevent; respiratory; seal; standard of care; tertiary care; treatment as usual

DESCRIPTION (provided by applicant): Critically ill patients who require treatment with mechanical ventilation (MV) are at an increased risk for complications that lead to prolonged days on the ventilator, high mortality, and increased resource use. Ventilation is delivered through an artificial airway, usually an endotracheal tube (ETT). Although essential, the ETT increases the risk of micro aspiration of secretions from the mouth and oropharynx into the lungs. Secretions may contain bacteria from the oral cavity, or gastric contents secondary to reflux. Therefore, micro aspiration can lead to ventilator-associated conditions (VAC), including lung injury and pneumonia. Several interventions, termed a "ventilator bundle," have been identified as best practices for MV patients and are routinely implemented. These targeted interventions have reduced infection, but do not address all factors associated with the development of VAC. Micro aspiration of secretions still occurs, increasing the risk for harm. Micro aspiration starts with accumulation of secretions in the mouth and oropharynx. Removal of oral secretions is not part of any ventilator bundle, and the procedure is neither standardized nor based on evidence. Therefore, a nursing intervention, enhanced oropharyngeal suctioning, that focuses on regular removal of these secretions beyond existing practices is important. This study will assess outcomes of a Nursing Oral Suction Protocol Intervention to Reduce Aspiration and Ventilator-Events (NO-ASPIRATE), a standardized, enhanced oropharyngeal suction procedure delivered every 4 hours. The long-term goal is to improve the care of patients on MV who are at a high risk for complications that begin with micro aspiration of secretions. The primary aim of this study is to assess if the addition of the NO-ASPIRATE intervention will be more effective than usual care in preventing micro aspiration in intubated, MV patients. A randomized, single- blind trial design-enrolling a convenience sample (n=560) of critically-ill, ventilated patients, age 18 years or older, who have an oral ETT-will be conducted at a tertiary care hospital to achieve a target sample size of 400 subjects randomized to receive either the NO-ASPIRATE (experimental group) or a usual care/sham intervention (usual care group) delivered every 4 hours by a study team member. Tracheal and oral specimens for analysis of α-amylase as a biomarker for micro aspiration will be obtained twice per day. VAC will be assessed by an algorithm developed by the Centers for Disease Control and Prevention. All subjects will receive the standard of care for MV patients. Data analysis will include logistic regression, survival analysis, and generalized estimating equations. The study will provide data to develop evidence-based standards for oral suction, a nurse-driven intervention, to prevent micro aspiration in critically ill patients.

描述（由申请人提供）：需要机械通气 (MV) 治疗的危重患者出现并发症的风险增加，从而导致使用呼吸机的时间延长、死亡率高和资源使用增加。 ，通常是气管插管 (ETT)，尽管这是必要的，但 ETT 会增加将口腔和口咽部的分泌物微吸入肺部的风险。分泌物可能含有来自口腔或胃的细菌。因此，微量误吸可导致呼吸机相关疾病 (VAC)，包括肺损伤和肺炎，已被确定为 MV 患者的最佳做法并常规实施。这些有针对性的干预措施减少了感染，但并没有解决与 VAC 发生相关的所有因素。微量误吸仍然会发生，从而增加了口腔和口咽部分泌物积聚造成的伤害风险。口腔分泌物不属于任何呼吸机组的一部分，并且该程序既不标准化也不基于证据，因此，本研究将评估以定期清除这些分泌物为重点的护理干预措施，即加强口咽抽吸。减少误吸和呼吸机事件的护理口腔抽吸方案干预（NO-ASPIRATE）的结果，这是一种每 4 小时进行一次的标准化、强化口咽抽吸程序。长期目标是改善误吸和呼吸机事件。对因分泌物微抽吸而出现并发症的风险较高的 MV 患者进行护理 本研究的主要目的是评估添加 NO-ASPIRATE 干预措施在预防微抽吸方面是否比常规护理更有效。一项随机、单盲试验设计——招募年龄 18 岁或以上、接受口服 ETT 的重症通气患者的便利样本（n=560）——将在三级护理医院的目标样本量为 400 名受试者，随机接受由研究团队成员每 4 小时提供一次的无抽吸（实验组）或常规护理/假干预（常规护理组）。用于分析 α-淀粉酶作为微抽吸的生物标志物，每天将获得两次 VAC 将通过疾病控制和预防中心开发的算法进行评估 所有受试者都将接受 MV 护理标准。数据分析将包括逻辑回归、生存分析和广义估计方程，该研究将提供数据来制定口腔抽吸的循证标准，这是一种由护士驱动的干预措施，以防止危重患者发生微误吸。