The Impact of a Barrier Enclosure on Endotracheal Intubation Duration and First Pass Attempt - A Randomized Controlled Trial
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
- Time to tracheal intubation (TTI)
研究概览
简要总结
The trial will be done to determine the impact of a barrier enclosure, COVID (coronavirus disease -19) barrier box on endotracheal intubation attempts, and duration. This study will be a prospective, open-label, randomized controlled trial. A total of 100 patients scheduled for elective surgery will be randomly assigned in two groups (intervention group and control group). Participating attending anesthesiologists will intubate the intervention group patients with COVID barrier box and the control group patients without the box. The anesthesiologists and the intervention group patients will be surveyed about their perception after the surgery. The result of this study will help in decision making about using COVID barrier box to minimize the viral transmission from patients to healthcare workers during the pandemic.
详细描述
Purpose:
To assess the time to tracheal intubation (TTI) and first-pass success rate for attending anesthesiologists intubating with COVID-related modifications with or without the use of a COVID barrier box.
Hypothesis:
Using a COVID barrier box for tracheal intubation with COVID-related modifications for attending anesthesiologists would be prolonged compared to not using one.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy American Society of Anesthesiologists (ASA) Classification 1 or 2 adults scheduled for elective surgery requiring orotracheal intubation
- •18 years of age or older
- •COVID negative (As defined by negative COVID swab plus absence of screening symptoms as defined by: Fever, Cough, Shortness of breath or difficulty breathing, Chills, Repeated shaking with chills, Muscle pain, Headache, Sore throat, New loss of taste or smell)
- •Anesthesiologist Participant Inclusion Criteria:
- •Attending Anesthesiologist
- •Have performed at least 5 prior intubations using McGrath videolaryngoscopes
- •Have performed at least 5 prior endotracheal intubations with the locally instituted COVID-related modifications
- •Must not have more than one prior experience with using the COVID barrier box on real patients (Prior to the study start; not inclusive of intubations done in the context of this study)
- •Have performed at least one practice intubation on a manikin with the COVID barrier box prior to initiation of study
- •Patient Participant
排除标准
- •Patient refusal, inability to consent or cooperate
- •Claustrophobia
- •Body habitus not allowing physical fit into COVID barrier box
- •History of documented difficult airway
- •Risk factors for difficult airway (Mallampati 3 or 4, thyromental distance less than 6 cm, interincisor distance less than 4 cm, upper lip bite test 2 or 3, body mass index (BMI) 30 or above, macroglossia, airway edema, blood in airway, cervical immobility, or any other concerning features deemed by attending anesthesiologist)
- •Risk factors for gastric aspiration
- •Allergy to rocuronium
- •Anesthesiologist Participant Exclusion Criteria:
- •Refusal to consent
- •Do not meet any of the inclusion criteria
结局指标
主要结局
Time to tracheal intubation (TTI)
时间窗: This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.
TTI is the time from when the laryngoscope blade passes between the patient's lips until the first upstroke of the capnograph trace. TTI will be measured by a third party observer outside of the operating room.
次要结局
- First pass success rate(This will be measured at the time of intubation for an elective surgical patient within 150 seconds of initiating the first attempt to intubate.)
- Number of alternative techniques used for intubation(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Number of intubation attempts(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Lifting force applied on laryngoscope blade(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Patient acceptability of the COVID Barrier Box(This question will be asked as part of a short questionnaire administered to patients when they meet the Post Anesthesia Care Unit (PACU) discharge criteria (usually 2 to 5 hours after surgery). It will take about 10 minutes to complete.)
- Number of Operators needed for intubation(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Cormack-Lehane Grade for the first attempt of intubation(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Vocal cord position(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Anesthesiologist perception of contributors to difficulty in intubation, if any(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Patient comments on the COVID Barrier Box(This question will be asked as part of a short questionnaire administered to patients when they meet the Post Anesthesia Care Unit (PACU) discharge criteria (usually 2 to 5 hours after surgery). It will take about 10 minutes to complete.)
- Total time of airway manipulation(This will be measured at the time of intubation for an elective surgical patient. It will take approximately 5 minutes.)
- Laryngeal pressure application(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Anesthesiologist perception of intubation difficulty(This will be filled out as part of a questionnaire after intubation is completed. It will take approximately 10 minutes to complete the full questionnaire..)
- Patient comfort with the COVID Barrier Box(This question will be asked as part of a short questionnaire administered to patients when they meet the Post Anesthesia Care Unit (PACU) discharge criteria (usually 2 to 5 hours after surgery). It will take about 10 minutes to complete.)
研究者
Anthony Chau
Clinical Assistant Professor
University of British Columbia