全身麻醉与径向支撑超声的意识镇静 (RESSOURCE)
全身麻醉的随机对照试验与径向支气管超声中的意识镇静试验，用于外周肺部病变
The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most widely used endoscopic technique in the investigation of peripheral pulmonary lesions (PPL). It is performed in relatively equal proportions under conscious sedation and general anesthesia by interventional pulmonologists throughout the world. Users of conscious sedation justify themselves by the fewer resources consumed and the absence of demonstration of a superior diagnostic yield of general anesthesia while users of general anesthesia claim diagnostic yield and comfort for the patient are superior with their approach. Our main objective is to compare the diagnostic yield of pEBUS under general anesthesia to that obtained under conscious sedation.
研究概览
地位
详细说明
This is a multicenter randomized clinical trial to compare the diagnostic yield of pEBUS under general anesthesia and conscious sedation in the context of the investigation of peripheral pulmonary lesions.
Participants will be recruited prospectively. Potential participants will be identified during the screening of procedure requisitions by the interventional pulmonology team. The participant will then be approached by the physician to obtain their consent to the procedure and the study during a first visit, which can be face-to-face, by phone or by telemedicine. During this visit, the research protocol and the risks involved will be explained to the participant by the physician to obtain their free and informed consent for both. After verifying eligibility criteria and obtaining consent, participants will be included in the study and randomized. Participants will be randomized to the type of sedation for the procedure (general anesthesia or conscious sedation) and the procedure can, then, be scheduled with the sedation mode assigned during randomization. During a second visit, which may take place on the same day as the first, the participant will undergo pEBUS under conscious sedation or general anesthesia depending on the group to which he was randomized. Prior to discharge, the participant's comfort questionnaires will be administered. One month after the procedure, the research team will consult the participant's medical record to review the results of the samples taken during the examination and to ensure that the participant have not suffered any late complications following the procedure. The patient will be instructed to contact the research team again if they believe they have had a late complication. The record will subsequently be reviewed at 1 and 2 years if the procedure is not diagnostic to validate the final clinical diagnosis of the treating team. Communication of the results and further treatment of the patient will be the responsibility of the referring physician or his team and not that of the research team.
In both groups, an ultrathin or thin bronchoscope (eg.: MP109 or P180/190 bronchosscope, Olympus, Tokyo, Japan) and a radial EBUS probe (eg.: UM-S20-17S or 20R-3, Olympus, Tokyo, Japan) will be used. A guidesheath can be used when performing pEBUS procedures with a thin bronchoscope but not when using an ultrathin. Each center will determine before beginning recruitment for the study whether a thin bronchoscope with or without guidesheath or an ultrathin bronchoscope without guidesheat will be used.
Centers must systematically use the same type of bronchoscope and guidesheath for all participants recruited according to their predetermined conduct. Minimally, a wash, forceps and a brush will be performed to sample lesion. Forceps biopsies will be taken until five macroscopically visible specimens are obtained, up to a maximum of 8 attempts. A single brushing as well as a cytological bronchoalveolar washing, of at least 50ml, will be carried out. At the discretion of the center, a peripheral needle for fine needle aspiration (FNA) may also be used (eg. Periview, Olympus, Tokyo, Japan). If used, 3 passes will be performed, but additional passes are permitted at the discretion of the endoscopist and depending on the material obtained macroscopically. Each center will determine before beginning recruitment for the study whether or not it will use FNA. Centers must systematically use it or not, for all participants recruited according to local predetermined sampling protocol.
A 1.1mm cryoprobe (Erbe, Tuebingen, Germany) can also be used at the discretion of the endoscopist. Cryobiopsies do not have to be performed or not performed in all participants in a center, in contrast to FNA, and can be used at the discretion of the bronchoscopist. Cryobiopsies may be used systematically in both arms of the study in a participating center. This latitude with the use of cryobiopsies is explained by the higher risk associated with cryobiopsies and the strong conviction of certain centers in the selective use of this technique (eg eccentric image of pEBUS). A minimum of 3 and a maxmimum of 5 cryobiopsies will be performed when using the cryoprobe.
The sequence of use of sampling tools will be at the discretion of the endoscopist. Rapid on-site examination (ROSE) may be used, but must be used systematically for every case in both arms of the study at the participating center. Each center will determine before beginning recruitment for the study whether it will use ROSE or not, as for FNA.
If systematic lymph node staging is performed, it will be performed after peripheral EBUS. ROSE may or may not be used for lymph node sampling.
Randomization will be carried out at the end of the first visit to allow the logistical organization of the second visit, which includes the intervention. A 1:1 randomization, stratified for center and the presence of a bronchus sign will be performed. A bronchus sign will be defined by the presence of a bronchus leading directly to the lesion. Randomization will be centralized using the RedCapMD computer platform including a computer-generated randomization table by a consultant statistician. Participating centers will not have access to the randomization table. The participant and the medical team performing the intervention cannot realistically be blinded to the group to which the participant was randomized, but the primary outcome will depend on the impression of the pathologist and physician reviewing the chart who will be blinded to the randomization group. The pathologist will also be blinded to the cryoprobe biopsies when reviewing other biopsies of the same patient (forceps, brush, fine needle and wash) to prevent contamination of his final diagnosis for the other biopsies by the cryoprobe biopsy. The cryoprobe biopsy will be reviewed by a second pathologist or the same pathologist after recording is impression for the other biopsies. At no time before the end of the study can the blinding be lifted for the pathologist or physician reviewing the final diagnosis.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Marc Fortin, MD
- 电话号码：5504 418-656-8711
- 邮箱：marc.fortin@criucpq.ulaval.ca
学习地点
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Quebec
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Québec、Quebec、加拿大、G1V 4G5
- 招聘中
- Institut universitaire de cardiologie et de pneumologie de Québec
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接触：
- Marc Fortin, Md, MSc
- 电话号码：1-418-656-8711
- 邮箱：marc.fortin@criucpq.ulaval.ca
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首席研究员：
- Marc Fortin, MD, MSc
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Athens、希腊
- 招聘中
- Sotiria Thoracic Diseases Hospital of Athens
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接触：
- Grigoris Stratakos, MD,PhD, FCCP
- 电话号码：+30-2107763448
- 邮箱：grstrat@hotmail.com
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首席研究员：
- Grigoris Stratakos, MD,PhD, FCCP
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Hesse
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Frankfurt am Main、Hesse、德国、60487
- 尚未招聘
- St. Elisabethen Hospital Frankfurt
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接触：
- Sammy Onyancha, MD
- 电话号码：+49 69 79390
- 邮箱：sammyonyancha@gmail.com
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首席研究员：
- Sammy Onyancha, MD
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Principality of Asturias
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Oviedo、Principality of Asturias、西班牙
- 尚未招聘
- Hospital Universitario Central de Asturias
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接触：
- Miguel Angel Ariza Prota, MD
- 电话号码：+34 985 10 80 00
- 邮箱：arizamiguel@hotmail.com
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首席研究员：
- Miguel Angel Ariza Prota, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years and ability to consent
- Peripheral lung lesion less than 5cm in average diameter on axial CT images (A lung lesion will be considered peripheral if it is located beyond the origin of the subsegmental bronchi and presumed not to be visible endoscopically in white light during the evaluation of the CT scan by an interventional pulmonologist.)
- Lesion deemed accessible by pEBUS by an experienced interventional pulmonologist
- Decision by the medical team and the patient to use pEBUS as a diagnostic modality for the lung lesion
Exclusion Criteria:
- Presence of multiple lung lesions with sampling of more than one lung lesion planned
- Planned use of electromagnetic navigation, augmented fluoroscopy or robotic bronchoscopy in addition to pEBUS. The use of virtual bronchoscopy planning is permitted
- Presence of suspicious lymph nodes (size ≥ 10mm and/or moderate or greater hypermetabolism) on imaging which are accessible by l-EBUS and for which rapid on-site cytological analysis will be used
- Contraindication to bronchoscopy or biopsies such as an unstable medical condition or uncorrected coagulopathy
- Current pregnancy or lactation
- Lack of free and informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Conscious sedation arm
In the conscious sedation group, the procedure will be performed through the nose or mouth at the discretion of the endoscopist. The patient will remain breathing spontaneously throughout the procedure and will be administered oxygen through a nasal cannula at an initial flow rate of 2L/min. A combination of propofol, fentanyl and midazolam boluses will be used to maintain moderate sedation. At IUCPQ-UL, fentanyl and midazolam will be used as in our routine practice. The boluses will be prescribed by a doctor experienced in conscious sedation (anesthesiologist, intensivist or pulmonologist) according to the patient's state of wakefulness assessed by the Richmond Agitation-Sedation Scale (RASS) .Centers will decide, prior to initiating recruitment locally, the drug combination used to sedate patients and they will maintain the use of the same drug combination throughout the study. |
In the conscious sedation group, the procedure will be performed through the nose or mouth at the discretion of the endoscopist. The patient will remain breathing spontaneously throughout the procedure and will be administered oxygen through a nasal cannula at an initial flow rate of 2L/min. A combination of propofol, fentanyl and midazolam boluses will be used to maintain moderate sedation. At IUCPQ-UL, fentanyl and midazolam will be used as in our routine practice. The boluses will be prescribed by a doctor experienced in conscious sedation (anesthesiologist, intensivist or pulmonologist) according to the patient's state of wakefulness assessed by the Richmond Agitation-Sedation Scale (RAS) .Centers will decide, prior to initiating recruitment locally, the drug combination used to sedate patients and they will maintain the use of the same drug combination throughout the study |
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实验性的：General anesthesia arm
In the general anesthesia group, an endotracheal tube larger than 7 will be used. The patient will be kept non-arousable to non-nociceptive stimulation (RASS = -5) by a perfusion including, at the anesthesiologist's discretion: fentanyl, sufentanyl, remifentanyl, midazolam or propofol. The sedation of this group will not be protocolized given the wide variety of practices in the participating centers, but the targeted level of sedation will be and the medication administered will be adjusted according to this target. The RASS will be evaluated every 5 minutes, or earlier if signs of arousal are present, to ensure that the intended target is maintained and adjustments to the rate of infusions as well as boluses may be made/administered by the anesthesiologist to maintain the targeted level of sedation. Patients may be paralyzed at the discretion of the anesthesiologit. The ventilatory parameters will be standardized according to the VESPA protocol |
In the general anesthesia group, an endotracheal tube larger than 7 will be used. The patient will be kept non-arousable to non-nociceptive stimulation (RAS = -5) by a perfusion including, at the anesthesiologist's discretion: fentanyl, sufentanyl, remifentanyl, midazolam or propofol. The sedation of this group will not be protocolized given the wide variety of practices in the participating centers, but the targeted level of sedation will be and the medication administered will be adjusted according to this target. The RAS will be evaluated every 5 minutes, or earlier if signs of arousal are present, to ensure that the intended target is maintained and adjustments to the rate of infusions as well as boluses may be made/administered by the anesthesiologist to maintain the targeted level of sedation. Patients may be paralyzed at the discretion of the anesthesiologit. The ventilatory parameters will be standardized according to the VESPA protocol |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic yield of pEBUS under general anesthesia and conscious sedation
大体时间：At recruitment completion (expected time 2 years)
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The diagnostic yield of pEBUS according to a strict definition, a procedure being defined as diagnostic if it allows a specific benign or malignant diagnosis using the samples obtained. Non-specific findings not allowing a precise diagnosis and accompanied by a follow-up evolution consistent with the findings (e.g.: non-specific inflammation followed by spontaneous resolution of the lesion) will not be considered diagnostic. Cryobiopies will be excluded from the primary outcome analysis as they may not be performed systematically in both groups. We do not primarly aim to evaluate the added value of cryobiopsy but to compare two modalities of sedation. The comparison between the diagnostic yields for the two types of sedation will be made with a χ2 test, if the distribution of the data is normal |
At recruitment completion (expected time 2 years)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic yield of pEBUS
大体时间：At recruitment completion (expected time 2 years)
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The diagnostic yield of pEBUS according to a strict definition with inclusion of cryobiopsy results. The comparison of the variables will be carried out with a χ2 test |
At recruitment completion (expected time 2 years)
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Diagnostic yield of pEBUS
大体时间：At recruitment completion (expected time 2 years)
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The diagnostic yield of pEBUS according to a strict definition, with and without inclusion of cryobiopsy results, amongst lesions under and over 20mm of average diameter. The comparison of the variables will be carried out with a χ2 test |
At recruitment completion (expected time 2 years)
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Diagnostic yield of pEBUS
大体时间：At recruitment completion (expected time 2 years)
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The diagnostic yield of pEBUS according to a liberal definition, a procedure being defined as diagnostic if it allows a specific benign or malignant diagnosis or if it demonstrates non-specific inflammation and that during follow-up a precise benign diagnosis is established or that the lesion regresses on serial imaging. This analysis will be performed with and without inclusion of cryobiopsies. The comparison of the variables will be carried out with a χ2 test |
At recruitment completion (expected time 2 years)
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Duration of the procedure
大体时间：Assessment will begin with the start of the procedure (bronchoscope insertion) and end at procedure completion (bronchoscope removal)
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The duration of the procedure from insertion of the bronchoscope to its removal, excluding the time spent on l-EBUS if applicable |
Assessment will begin with the start of the procedure (bronchoscope insertion) and end at procedure completion (bronchoscope removal)
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Duration of the procedure
大体时间：Assessment will begin when the participant enters the procedure room and end when he leaves it. Result will be recorded when the patient leaves the procedure room.
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The duration of the procedure from patient's procedure room entry to his departure from the procedure room. |
Assessment will begin when the participant enters the procedure room and end when he leaves it. Result will be recorded when the patient leaves the procedure room.
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Recovery duration
大体时间：Assessment will begin when the participant leaves the procedure room and end when he is discharged from the recovery room. Result will be recorded when the patient is discharged from the recovery room.
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The duration of post-procedure recovery before reaching the criteria for discharge (PADS ≥ 9 and adequate oxygen saturation) |
Assessment will begin when the participant leaves the procedure room and end when he is discharged from the recovery room. Result will be recorded when the patient is discharged from the recovery room.
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Participant Comfort
大体时间：Questionnaires will be administered once the patient is ready for discharge from the recovery room
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Comfort during the examination according to the patient's answers to two Likert scales of memory of the procedure (absolutely no memory, no specific details, a few details, most of the details, all the details) and willingness to repeat the examination if medically required (definitely not, probably not, uncertain, probably, definitily), and a comfort questionnaire regarding their perception during and after the procedure (dyspnea, cough, pain, anxiety, nausea, general discomfort) |
Questionnaires will be administered once the patient is ready for discharge from the recovery room
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Adverse event rates
大体时间：At recruitment completion (expected time 2 years)
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The rate of adverse events and serious adverse events of pEBUS under general anesthesia versus conscious sedation |
At recruitment completion (expected time 2 years)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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