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临床试验/NCT00852384
NCT00852384已完成4 期

Non Invasive Pressure Support Ventilation (NIPPV) Versus Conventionnal Approach and Early Recruitment Maneuver (RM) for Preoxygenation of Morbidly Obese Patient

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation

研究概览

简要总结

The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

详细描述

Atelectasis formation during general anesthesia, leading to reduced end-expiratory lung volume, is an important cause of intrapulmonary shunt leading to impaired gas-exchange and hypoxemia. During general anesthesia and the immediate postoperative period, morbidly obese patients, who develop a larger amount of atelectasis than non-obese patient, are more likely to present impairment of gas exchange and respiratory mechanics. Noninvasive positive-pressure support ventilation (NIPPV) and positive end-expiratory pressure (PEEP) are effective to provide oxygenation during intubation of hypoxemic patients. Recent data suggest that NIPPV enhances preoxygenation in morbidly obese patients. Moreover, the application of PEEP during induction of anesthesia prevents atelectasis formation and increases nonhypoxic apnea duration in obese patients despite the use of high-inspired oxygen fraction. However, the use of both NIPPV is widely used in the operating room, because of technical and materials constraints.

Several trials have demonstrated that alveolar recruitment maneuvers (RM) are effective to remove atelectasis and improve lungs mechanics and gas-exchange.

The purpose of this randomized and controlled study is to compare the effects of two ventilatory strategies during anesthesia induction of morbidly obese patients on both gas-exchange and functional residual capacity (FRC) modifications: 1- Control group: preoxygenation using 100% O2 via a face-mask and PEEP 10 cmH2O after intubation; 2- NIPPV group: preoxygenation using NIPPV and PEEP 10 cmH2O after intubation; 3- RM group: preoxygenation using 100% O2 via a face-mask and early RM plus PEEP 10 cmH2O after intubation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

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

  • Body mass index (BMI > 30 kg/m2)
  • Age > 18 years
  • ASA I-III

排除标准

  • Age < 18 years
  • Patient refusal
  • Pregnancy
  • Emergency surgery
  • COPD with FEV1 < 50%
  • History of pneumothorax
  • Severe asthma
  • Cardiac failure (NYHA > 2)
  • Ischemic heart disease

结局指标

主要结局

Oxygenation (PaO2) measured 5min after the onset of mechanical ventilation

时间窗: 5 min after the oneset of mechanical ventilation

次要结局

  • - FRC after tracheal intubation and after 5 min of mechanical ventilation(after 5 min of mechanichal ventilation)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other

研究点 (2)

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