Saturation and Nursing Interventions in Patients Receiving Supplemental Oxygen Therapy During the First Night After Metabolic and Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 563
- 试验地点
- 1
- 主要终点
- Number of desaturations per patient
研究概览
简要总结
The goal of this observational study is to learn about the effect of supplemental oxygen therapy during the first night after bariatric and metabolic surgery in a population that is not (routinely) tested for obstructive sleep apnea preoperatively.
The main question to answer in this study is:
How many desaturations occur while participants receive supplemental oxygen therapy and how many, and what type of nursing interventions are needed? Another question we want to answer is: are there characteristics that seems to increase the risk of developing a desaturation?
详细描述
This is a prospective observational study that aims to characterize the number of desaturations and nursing interventions in a population with a unknown structive sleep apnea status receiving supplemental oxygen therapy during the first night after metabolic and bariatric surgery. The secondary aim is to to identify patient characteristics that are associated with a higher risk of developing desaturations.
Methods:
Participants receive standard of care, which includes 2 liters of supplemental oxygen therapy during the first postoperative night after metabolic and bariatric surgery while being continously monitored.
The desaturations, saturation and number and type of nursing intervention were collected along with patient characteristics (see outcomes) Sample size: A population proportion sample size was used, a CI 95%, margin of error 5% , proportion of 0.50, gave a required sample size of 385 participants.
Mann Whitney U-test (continuous data) and Fishers exact test (categorical data) are used to compare spo2 and nursing interventions between participants with and without desaturations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing primary metabolic and bariatric surgery
- •Overnight hospital stay
排除标准
- •Undergoing secundary metabolic and bariatric surgery (e.g. redo surgery)
- •Having treated obstructive sleep apnea (CPAP, oral application)
- •Having chronic obstructive pulmonary disease
- •No overnight hospital stay at the nursing ward (same-day discharge or overnight stay at medium or intensive care)
结局指标
主要结局
Number of desaturations per patient
时间窗: First postoperative night
Participants were continuously monitored and all desaturations (spo2\<90%) were collected.
Number of nursing interventions
时间窗: First postoperative night
If nurses had to intervene because of a desaturation or to prevent a desaturation (e.g. waking patient, putting back nasal cannula, increasing oxygen flow)
Type of nursing intervention
时间窗: First postoperative night
which nursing intervention the nursed provided was documented on a form (e.g. putting back nasal cannula, increasing oxygen flow, jaw thrust)
次要结局
- The effect of the patient characterisic "sex" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "age" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "body mass index" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "smoking status" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "chronic benzodiazepine use" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "diabetes mellitus type 2" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "hypertension" on the risk of developing desaturations(First postoperative night)
- The effect of the patient characterisic "dyslipidemia" on the risk of developing desaturations(First postoperative night)
- The effect of operating time on the risk of developing desaturations(First postoperative night)
- The effect postoperatively used morphine milligram equivalent on the risk of developing desaturations(First postoperative night)
- The effect intraoperatively used morphine milligram equivalent on the risk of developing desaturations(First postoperative night)
- The effect of rocuronium on the risk of developing desaturations(First postoperative night)
- The effect of sugammadex on the risk of developing desaturations(First postoperative night)