跳至主要内容
临床试验/NCT03876873
NCT03876873已完成不适用

A Prospective, Randomized, Non-Blinded, Crossover Controlled Clinical Trial Evaluating the Efficacy of Face Mask Ventilation With 45 Degree Head Rotation in Anesthetized Obese (BMI ≥ 35) Adults

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Maximal and Average Expiratory Tidal Volume During Mask Ventilation

研究概览

简要总结

Mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. For general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. Medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. In this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.

详细描述

Mask ventilation is a foundation of airway management after the initial induction of anesthesia. It allows for adequate oxygenation of the patient to buy enough time for intubation, during which the patient is not ventilated. However, in some patients mask ventilation may be difficult - older than 55 years, heavier (BMI > 26 kg/m^2), with no teeth, having a beard or sleep apnea. Inadequate ventilation, if not corrected, can result in decreasing oxygen saturation to dangerous levels - which could lead to devastating complications. As a result, the efficacy of mask ventilation is of critical importance to patient safety after the induction of anesthesia.

A recent study proposed that mask ventilation could be improved simply by turning a patient's head. The study showed that rotating a patient's head to a 45 degree angle significantly improved mask ventilation when compared with the head placed in a neutral position. However, this study was done in patients with a BMI lass than 35. As such, the effects of head rotation on the efficacy of mask ventilation has not been studied in patients with a BMI of 35 and greater.

Obesity (BMI ≥ 30 kg/m^2) affects almost 40% of US adults and is one of the most prevalent health concerns in our society. It is a predictor of difficult mask ventilation because it is associated with increased upper airway obstruction, decreased airway patency, and decreased lung volumes such as functional residual capacity (FRC). If previous findings in regard to the effects of 45 degree head rotation on the efficacy of ventilation hold true in the obese patient, then this study will show that head rotation could be used as a simple way to improve the efficacy of mask ventilation for patients with a BMI of 35 and above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The surgeon, anesthesiologist, operating room staff, and participants will not know the group assignment at the time of subject recruitment. No blinding will occur during the clinical portion of the study or during data analysis.

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

  • Age ≥ 18 years
  • ASA Physical Status Classification I-III
  • Body Mass Index (BMI) ≥ 35 kg/m^2

排除标准

  • Inability to obtain written informed consent
  • Pregnant or breastfeeding
  • Limited head rotation or neck extension
  • Subjects with expected or history difficult intubation
  • Large beard
  • Orogastric (OG)/nasogastric (NG) tube
  • Gastroesophageal Reflux Disease (GERD)

结局指标

主要结局

Maximal and Average Expiratory Tidal Volume During Mask Ventilation

时间窗: Day 1

Measured in mL

次要结局

  • Maximal and Average Airway Flow During Mask Ventilation(Day 1)
  • Maximal and Average Inspiratory Tidal Volume During Mask Ventilation(Day 1)
  • Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation(Day 1)
  • Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation(Day 1)
  • Lowest and Delta O2 Saturation Drop on SpO2 During Intubation(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boris Mraovic

Professor

University of Missouri-Columbia

研究点 (2)

Loading locations...

相似试验