跳至主要内容
临床试验/NCT01078207
NCT01078207已完成不适用

A Prospective Non-Randomized Study of Pulse Oximetry Saturation Patterns in Postoperative Patients at High Risk of Obstructive Sleep Apnea

Medtronic - MITG2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.

研究概览

简要总结

This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.

详细描述

There is no further detailed description available.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery.
  • Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study
  • Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs.
  • Patients in the ASA category 1-4
  • Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.)
  • Spontaneous breathing

排除标准

  • Age less than 18 years
  • Patients receiving or anticipated to receive postoperative positive airway pressure support
  • Previous allergic/contact reactions to adhesives
  • Patients unable to give informed consent
  • Pregnancy

结局指标

主要结局

Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.

时间窗: 12 hour after released from the recovery room

Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects

次要结局

  • Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.(12 hours after discharge form the recovery room)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验