Evaluation of Different Pre-Oxygenation Conditions in Morbid Obesity: Position and Ventilation Mode, in a Respiratory Physiology Laboratory, on Voluntary Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Functional Residual Capacity
研究概览
简要总结
The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature.
This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.
详细描述
Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes.
Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight.
The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume.
Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 > 90 % and a longer non-hypoxic apnea time (Sat O2 >90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique.
We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 40 - 80 kg / m2
- •Waist circumference: Men: More than 130 cm
- •Waist circumference: Women: More than 115 cm
排除标准
- •Facial hair
- •Cranio-facial abnormality
- •Claustrophobia
- •COPD (defined by FEV1 < 80 %)
- •Severe cardiovascular disease (defined by NYHA ≥3)
- •Pregnancy
- •Tobacco use
- •NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).
研究组 & 干预措施
Supine
NIPPV and Tidal volume
干预措施: NIPPV (Procedure)
Supine
NIPPV and Tidal volume
干预措施: Tidal volume (Procedure)
Beach-chair (Back : 25 deg)
NIPPV and Tidal volume
干预措施: NIPPV (Procedure)
Beach-chair (Back : 25 deg)
NIPPV and Tidal volume
干预措施: Tidal volume (Procedure)
Proclive (Global 25 deg)
NIPPV and Tidal volume
干预措施: NIPPV (Procedure)
Proclive (Global 25 deg)
NIPPV and Tidal volume
干预措施: Tidal volume (Procedure)
结局指标
主要结局
Functional Residual Capacity
时间窗: After a 5 minutes pre-oxygenation period
Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.
次要结局
- Patient's Comfort(At the end of a 5 minutes pre-oxygenation period)
- Diaphragmatic Amplitude.(After a 5 minutes pre-oxygenation period)
- Respiratory Mechanics(At the end of a 5 minutes pre-oxygenation period)
研究者
Jean Bussières
Anesthesiologist
Laval University
