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临床试验/NCT05495841
NCT05495841已完成不适用

OPTiMASK: Comparison of Pre-oxygenation With Standard Face Mask Combined With High Flow Nasal Oxygen With Pre-oxygenation With Standard Face Mask Alone

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月18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
80
试验地点
1
主要终点
Lowest EtO2 value

研究概览

简要总结

This is an observational, prospective study of patients undergoing a surgical procedure. Three parallel studies are taking place with collaborators in other countries. This study aims to bring novel insights regarding the benefits of pre-oxygenation combining standard oxygen facemask with high-flow nasal oxygen (HFNO), as opposed to standard oxygen facemask alone by assessing end-tidal oxygen (ETO2) levels after intubation.

详细描述

This is an observational, prospective study of patients undergoing a surgical procedure. A total of 80 patients will be enrolled at BIDMC. Patients meeting inclusion criteria with no exclusions will be approached for consent. 40 patients receiving the pre-oxygenation face mask alone method during clinical routine and 40 patients using the pre-oxygenation combined facemask + HFNO technique as part of routine clinical care will be studied. No randomization will be employed. Choice of pre-oxygenation approach is at the discretion of the clinician. Patients will be enrolled as a convenience sample, such that the first 40 patients will be those with face mask alone, and the second 40 will be patients with face mask + HFNO. Research assistants will discuss the pre-oxygenation plan with the anesthesiologist as part of the screening process. Data will be collected including EtO2 levels during two minutes following intubation.

Methodology

  1. Face mask alone: As per clinical standard, the standard oxygen facemask will be tightly applied on the face of the patient at 100% FiO2 for 3 to 4 minutes. In case of suspected full stomach, it is recommended to perform a rapid sequence induction and the patient does not receive bag-mask ventilation during the apnea period (45-60s). In the other case, a standard pre-oxygenation will be performed (see figure 1: experimental design of the study).
  2. Face mask + Nasal cannula: As to clinical standards, the standard oxygen facemask will be tightly applied on the face of the patient at 100% FiO2 for 3 to 4 minutes and HFNO at 100% with a flow at 40 L/minutes during the pre-oxygenation (the flow can be decreased to less than 40 L/minutes if no tolerance by the patient). Then, after a general anesthesia induction and/or a rapid sequence induction is performed, the patient receives HFNO at 100% FiO2 and the flow of HFNO is increased to up to 80 L/minutes (which corresponds to a close delivered FiO2 at 80%) during the apnea period (1 to 2 min) until correct position of the endotracheal tube is confirmed with capnography.

Assessments The study does not require any research procedures other than passive data collection. For this study, EtO2 levels will be recorded at more frequent intervals than what is entered in the anesthesia record. Therefore, study staff will collect these data from the anesthesia machine in the operating room, where values are displayed on a breath-by-breath basis

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

入选标准

  • 18 years and older
  • All consecutive patients for scheduled or non-scheduled surgery with or without indication of rapid sequence induction (full-stomach)
  • Undergoing general anesthesia with orotracheal intubation

排除标准

  • Age < 18 years
  • Hemodynamic instability
  • Intubation without laryngoscopy (i.e., fiberoptic intubation for anticipated "cannot ventilate situation" or mouth opening < 2 cm), facial surgery
  • Adults subject to legal protection
  • Pregnancy (due to higher risk of oxygen desaturation and aspiration)

结局指标

主要结局

Lowest EtO2 value

时间窗: start of intubation to 2 minutes after

Lowest EtO2 value within the two minutes following tracheal intubation

次要结局

  • Highest level of EtCO2(start of intubation to 2 minutes after)
  • SpO2 at the start and at the end of the procedure(start of intubation to 4 minutes after)
  • Tolerance of the device(entirety of procedure)
  • Number of laryngoscopy attempts(before surgical procedure)
  • Lowest SpO2(start of intubation to 2 minutes after)
  • Rate of oxygen desaturation(entirety of procedure)

研究者

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

Daniel Talmor

Anesthesia Department Chair

Beth Israel Deaconess Medical Center

研究点 (1)

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