Normal Saline Use With Suctioning: A Randomized-Controlled Trial - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Heart Rate
研究概览
简要总结
A long-standing intervention during tracheostomy tube suctioning in acute care settings is use of saline to loosen and remove respiratory tract secretions, maintain airway patency, and prevent mucus plugs. Controversy exists regarding safely using saline prior to suctioning for head and neck cancer and mechanically ventilated patients. To date, all studies had methodological limitations. In 2013, the clinical consensus statement published by AAO-HNSF identified a research gap based on lack of strong scientific evidence. A single site, randomized controlled pilot study will be conducted to evaluate effects of saline instillation with tracheostomy tube suctioning; test feasibility of proposed methods and procedures; and ensure proposed outcome variables are measurable and not confounded by extraneous variables. Institutional review board approval will be obtained before eligible adult subjects (inpatient and intensive care units) are recruited and consented. Oxygen saturation and heart rate are primary outcome variables; secondary outcome variables are mucus plugs and ventilator-associated pneumonias; other demographic data and patient characteristic variables; and outcome variables on complications and length of stay. Mean, standard deviation, median, and interquartile range will be calculated for continuous variables using t-tests to compare pre- and post-assessment scores. Frequencies and percentages will be calculated for categorical variables using Chi square and Fisher Exact tests to compare pre- and post-assessment scores. Multiple regression analysis will be used to control for confounding variables. This study is innovative as the first to recruit both head and neck cancer patients and mechanically ventilated patients and to measure all major outcomes of interest in one study. Understanding the effects of normal saline instillation will enable development of evidence-based guidelines and standardized protocols for tracheostomy tube suctioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients, ages 18 or older, cared for on adult inpatient units/wards.
- •Patients who have a tracheostomy tube.
- •Tracheostomy tube has been in place at lease for 72 hours (to avoid any late effects of anesthesia that was administered at the time of tracheostomy tube placement).
- •Patients must have a physician order to suction the tracheostomy tube at least every 8 hours. This will help us to recruit patients for whom suctioning is already part of standard care. Therefore, patients will not undergo unnecessary suctioning for the purpose of the study.
- •Expected hospitalization to be 5 days or greater after consent.
排除标准
- •Fresh tracheostomy that still has bleeding from the stoma (< 72 hours since the surgical placement of a tracheostomy tube).
- •Active respiratory distress or hemodynamic changes that warrant a change in the existing treatment plan.
- •Patients who are expected to die or undergo withdrawal of treatment within 48 hours.
- •Patients who are allergic to latex to avoid a reaction with the red rubber suction catheter that will be used in the study.
研究组 & 干预措施
Saline Instillation
3mL normal saline from pink sodium chloride bullet instilled into tracheostomy immediately prior to suctioning.
干预措施: 3mL of normal saline from the pink sodium chloride bullet (Other)
Placebo
Pretend to instill 3mL of normal saline using empty pink sodium chloride bullet immediately prior to suctioning.
干预措施: Sham Comparator of 3mL normal saline (Other)
结局指标
主要结局
Change in Heart Rate
时间窗: immediately prior to intervention, immediately after intervention, immediately after suctioning patient, again at 1-minute and 5-minute post-suction. Repeated 3 times daily for 5 consecutive days
Change in Oxygen Saturation
时间窗: immediately prior to intervention, immediately after intervention, immediately after suctioning patient, again at 1-minute and 5-minute post-suction. Repeated 3 times daily for 5 consecutive days
次要结局
- Quality of Life Questionnaire for Mechanically Ventilated ICU patients(5 Days)
- Patient's Experience with Normal Saline Instillation and Tracheostomy Tube Suctioning Questionnaire.(5 Days)
- Change in Blood Pressure(immediately prior to intervention, immediately after suctioning patient, again at 1-minute and 5-minute post-suction. Repeated 3 times daily for 5 consecutive days)
- Secretion Volume measured after suctioning patient.(5 days)