NIRS-Based Cerebral Oximetry Monitoring in Elderly Thoracic Surgical Patients Undergoing Single Lung Ventilation Procedures: A Single Center, Prospective, Randomized Controlled Pilot Study Assessing the Clinical Impact of NIRS-Guided Intervention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Relationship of Assignment Group to PACU Length of Stay.
研究概览
简要总结
This is a prospective, randomized controlled pilot study of cerebral oximetry use in elderly patients undergoing thoracic surgical procedures that require the use of single lung ventilation. The hypothesis is that subjects randomized to open cerebral oximetry monitoring that have active intervention to mitigate observed desaturations will have measurable postoperative clinical outcome benefits when compared to the patients randomized to blinded cerebral oximetry monitoring with no active interventions to mitigate desaturations.
详细描述
Study Rationale The use of bi-frontal, near infrared spectrophotometry (NIRS) based cerebral oximetry monitoring has been demonstrated to result in improved clinical outcomes in both general surgery patients and cardiac surgical patients using prospective, randomized controlled trial methodology. Elderly thoracic surgical patients undergoing procedures that involve single lung ventilation may also stand to benefit from the application of intraoperative and early postoperative NIRS cerebral oximetry monitoring. Cerebral oximetry has not been established as a standard of care monitoring modality in this patient population, thus permitting the application of randomized, controlled testing methodology to assess the potential impact of this monitoring modality upon these patients.
Hypothesis and Objectives:
The primary hypothesis in this pilot study of elderly thoracic surgical patients undergoing procedures involving single lung ventilation (SLV) is that there will be a measurable and significant clinical benefit (as assessed by a broad range of postoperative clinical outcome measures) to the subjects randomized to the intervention cohort (open bi-frontal NIRS based cerebral oximetry monitoring with a standardized intervention protocol) vs. the control cohort (blinded bi-frontal NIRS based cerebral oximetry monitoring).
The primary objective of this pilot study is to identify the most relevant clinical outcome variables which significantly diverge as a result of being randomized to the intervention cohort vs. the control cohort so that a larger, multicenter, prospective, randomized controlled clinical trial can be designed to further test the primary hypothesis as stated in the preceding section. The subsequent larger, multicenter trial will be conducted to definitively demonstrate the ability of INVOS® 5100 guided NIRS-based bi-frontal monitoring to improve clinical outcomes in this surgical patient group and potentially establish a new U.S. Food and Drug Administration cleared indication for this monitoring modality. The clinical outcome variables being assessed as the primary objective are many and a detailed list of these variables can be found in the OUTCOME MEASURES - Primary Outcome Measure Section of this submission.
Secondary objectives of this pilot study include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or female patient ≥ 65 years of age and able to provide informed consent (or consent may be provided by a legally authorized representative) who is scheduled for a thoracic surgical procedure that is expected to involve the use of intraoperative single lung ventilation (SLV)
- •Able to adequately complete a baseline mini-mental status examination (MMSE)
- •Able to complete a baseline confusion assessment method (CAM) examination
- •Able to obtain bi-frontal baseline rSO2 values prior to induction of anesthesia
排除标准
- •Any patient who has participated in a clinical study of an investigational drug or device in the past 30 days
- •Any patient who the principal investigator feels at any time or for any reason should not participate in this clinical study
- •Withdrawal of informed consent for any reason
研究组 & 干预措施
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: Vasoconstrictor Agents (Drug)
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: Head/neck repositioning (Other)
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: Increase ETCO2 (Other)
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: IV fluid bolus (Other)
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: Additional anesthesia (Drug)
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: RBC transfusion (Biological)
Intervention cohort
Open cerebral oximetry monitoring; observed desaturations will be treated with an intervention algorithm including increase FiO2, head/neck repositioning,vasoconstrictor agents, IV fluid bolus, increase ETCO2, additional anesthesia, RBC transfusion.
干预措施: Increase FiO2 (Drug)
结局指标
主要结局
Relationship of Assignment Group to PACU Length of Stay.
时间窗: One year
Relationship of assignment group (i.e. control vs intervention group) to PACU LOS
Relationship of AUC Cerebral Desaturations to ICU LOS
时间窗: One year
Relationship of AUC cerebral desaturations to ICU LOS
Relationship of AUC Cerebral Desaturations to Observed Volume of Crystalloid/Colloid Administered in the Operating Room
时间窗: One year
Relationship of AUC cerebral desaturations to observed volume of crystalloid/colloid administered in the operating room
Relationship of AUC Cerebral Desaturations to Observed Amount of Anti-emetic Meds Administered in the Operating Room
时间窗: One year
Relationship of AUC cerebral desaturations to observed amount of anti-emetic meds administered in the operating room
Relationship of Assignment Group to ICU LOS
时间窗: One year
Relationship of assignment group to ICU LOS
Relationship of AUC Cerebral Desaturations to AUC of Mean Arterial Blood Pressure
时间窗: One Year
Relationship of AUC cerebral desaturations to AUC of mean arterial blood pressure
Relationship of AUC Cerebral Desaturations to Transfusion of Red Blood Cells
时间窗: One year
Relationship of AUC cerebral desaturations to transfusion of red blood cells
Relationship of AUC Cerebral Desaturations to Observed Operating Room Time
时间窗: One year
Relationship of AUC cerebral desaturations to observed operating room time
Relationship of Assignment Group to Observed Volume of Crystalloid/Colloid Administered in the Operating Room
时间窗: One year
Relationship of assignment group to observed volume of crystalloid/colloid administered in the operating room
Relationship of Assignment Group to Reported Surgical Procedure Performed
时间窗: One year
Relationship of assignment group to reported surgical procedure performed
The Primary Objective of This Pilot Study is to Identify the Most Relevant Clinical Outcome Variables Which Significantly Diverge as a Result of Being Randomized to the Intervention Cohort vs. the Control Cohort.
时间窗: One year
The clinical endpoints are defined by the clinical outcome variables assessed and include relationship of assignment group and AUC of cerebral desats and their observed relationship to PACU/hospital/ICU LOS, AUC of mean arterial blood pressure, IV vasoactive drugs, intraop mLs urine/kg/hr in OR, red blood cell(RBC) transfusion, change in surgical procedure, intra/postop stroke/TIA/MI/afib/AUC glucose \> 110 mg/dL, OR time, narcotic administered in the OR, volume of crystalloid/colloid administered in the OR, Anti-emetic meds administered in the OR, Surgical procedure performed, Time on single lung ventilation, Intraop Use of epidural catheter, aldrete PACU score, frequency/severity of N/V in the PACU/ICU, mech vent time in the PACU/ICU, need for postop skilled nursing facility/rehab hospital, need for hospital readmission, change in MMSE/CAM scores from baseline, change in renal fxn compared to baseline, return of bowel function time, postop infection, postop composite endpoint
Relationship of Assignment Group to AUC of Mean Arterial Blood Pressure
时间窗: One Year
Relationship of assignment group to AUC of mean arterial blood pressure
Relationship of Assignment Group to Observed Intraoperative mLs Urine/kg/hr
时间窗: One year
Relationship of assignment group to observed intraoperative mLs urine/kg/hr
Relationship of Assignment Group to Transfusion of Red Blood Cells
时间窗: One year
Relationship of assignment group to transfusion of red blood cells
Relationship of Assignment Group to Observed Frequency of Intraoperative or Postoperative Stroke
时间窗: One Year
Relationship of assignment group to observed frequency of intraoperative or postoperative stroke
Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to PACU LOS
时间窗: One year
Relationship of AUC of cerebral desats to PACU LOS
Relationship of AUC Cerebral Desaturations to Observed Intraoperative mLs Urine/kg/hr
时间窗: One year
Relationship of AUC cerebral desaturations to observed intraoperative mLs urine/kg/hr
Relationship of AUC Cerebral Desaturations to Observed Frequency of Any Change in Surgical Procedure
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency of any change in surgical procedure
Relationship of Assignment Group to Observed Frequency of Transient Ischemic Attack
时间窗: One year
Relationship of assignment group to observed frequency of transient ischemic attack
Relationship of AUC Cerebral Desaturations to Observed Frequency of Myocardial Infarction
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction
Relationship of Assignment Group to Hospital Length of Stay (HLOS)
时间窗: One Year
Relationship of assignment group (i.e. control vs intervention group) to HLOS
Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to HLOS
时间窗: One year
Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS
Relationship of Assignment Group to Observed Frequency of Any Change in Surgical Procedure
时间窗: One year
Relationship of assignment group to observed frequency of any change in surgical procedure
Relationship of AUC Cerebral Desaturations to Observed Frequency of Intraoperative or Postoperative Stroke
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency of intraoperative or postoperative stroke
Relationship of AUC Cerebral Desaturations to Observed Frequency of Transient Ischemic Attack
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency of transient ischemic attack
Relationship of Assignment Group to Observed Frequency of AUC Glucose > 110 mg/dL
时间窗: One year
Relationship of assignment group to observed frequency of AUC glucose \> 110 mg/dL
Relationship of AUC Cerebral Desaturations to Observed Frequency of AUC Glucose > 110 mg/dL
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency of AUC glucose \> 110 mg/dL
Relationship of Assignment Group to Observed Operating Room Time
时间窗: One year
Relationship of assignment group to observed operating room time
Relationship of Assignment Group to Observed Amount of Narcotic Administered in the Operating Room
时间窗: One year
Relationship of assignment group to observed amount of narcotic administered in the operating room
Relationship of AUC Cerebral Desaturations to Observed Change in CAM or MMSE Scores From Baseline
时间窗: One year
Relationship of AUC cerebral desaturations to observed change in CAM or MMSE scores from baseline
Relationship of Assignment Group to Observed Change in Renal Function From Baseline
时间窗: One year
Relationship of assignment group to observed change in renal function from baseline
Relationship of Assignment Group to Observed Frequency of Myocardial Infarction
时间窗: One year
Relationship of assignment group to observed frequency of myocardial infarction
Relationship of AUC Cerebral Desaturations to Observed Frequency of Atrial Fibrillation
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation
Relationship of AUC Cerebral Desaturations to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit
时间窗: One year
Relationship of AUC cerebral desaturations to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit
Relationship of AUC Cerebral Desaturations to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility
时间窗: One year
Relationship of AUC cerebral desaturations to observed need for postoperative discharge to skilled nursing/rehabilitation facility
Relationship of Group Assignment to Any Observed Postoperative Infection
时间窗: One year
Relationship of group assignment to any observed postoperative infection
Relationship of AUC Cerebral Desaturations to Any Observed Postoperative Infection
时间窗: One year
Relationship of AUC cerebral desaturations to any observed postoperative infection
Relationship of Assignment Group to Observed Frequency of Atrial Fibrillation
时间窗: One year
Relationship of assignment group to observed frequency of atrial fibrillation
Relationship of AUC Cerebral Desaturations to Observed Amount of Narcotic Administered in the Operating Room
时间窗: One year
Relationship of AUC cerebral desaturations to observed amount of narcotic administered in the operating room
Relationship of Assignment Group to Observed Amount of Anti-emetic Meds Administered in the Operating Room
时间窗: One year
Relationship of assignment group to observed amount of anti-emetic meds administered in the operating room
Relationship of AUC Cerebral Desaturations to Reported Surgical Procedure Performed
时间窗: One year
Relationship of AUC cerebral desaturations to reported surgical procedure
Relationship of Assignment Group to Observed Time on Single Lung Ventilation
时间窗: One year
Relationship of assignment group to observed time on single lung ventilation
Relationship of Assignment Group to Observed Frequency and Severity of Nausea/Vomiting in the Post Anesthesia Care Unit/Intensive Care Unit
时间窗: One year
Relationship of assignment group to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit
Relationship of AUC Cerebral Desaturations to Observed Need for Hospital Readmission
时间窗: One year
Relationship of AUC cerebral desaturations to observed need for hospital readmission
Relationship of Assignment Group to Observed Time to Wean From Postoperative Supplemental Oxygen
时间窗: One year
Relationship of assignment group to observed time to wean from postoperative supplemental oxygen
Relationship of Assignment Group to Observed Incidence of Postop Morbidity Composite Endpoint (Defined in Description Section Below)
时间窗: One year
Relationship of assignment group to observed incidence of postop morbidity composite endpoint (defined by having any 1 of the following: new onset afib, ≥Grade 2 PONV, HLOS≥4.5 days, PACU LOS≥2 hours, any infection, death, stroke, MI, greater 0.5 mg/dL increase in Cr or new need for renal dialysis, postop need for IV inotropes or vasoactive meds)
Relationship of AUC Cerebral Desaturations to Observed Incidence of Postoperative Morbidity Composite Endpoint (Defined in Description Section Below)
时间窗: One year
Relationship of AUC cerebral desaturations to observed incidence of postoperative morbidity composite endpoint (defined by having any one of the following: new onset atrial fibrillation, ≥Grade 2 PONV, HLOS≥4.5 days, PACU LOS≥2 hours, any infectious complication, death, stroke, myocardial infarction, greater 0.5 mg/dL increase in creatinine or new need for renal dialysis, postoperative need for intravenous inotropes or vasoactive medications)
Relationship of AUC Cerebral Desaturations to Observed Frequency and Severity of Nausea/Vomiting in the Post Anesthesia Care Unit/Intensive Care Unit
时间窗: One year
Relationship of AUC cerebral desaturations to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit
Relationship of Assignment Group to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility
时间窗: One year
Relationship of assignment group to observed need for postoperative discharge to skilled nursing/rehabilitation facility
Relationship of Assignment Group to Observed Need for Hospital Readmission
时间窗: One year
Relationship of assignment group to observed need for hospital readmission
Relationship of Assignment Group to Observed Change in CAM or MMSE Scores From Baseline
时间窗: One year
Relationship of assignment group to observed change in CAM or MMSE scores from baseline
Relationship of Assignment Group to Observed Time to Return of Bowel Function Time
时间窗: One year
Relationship of assignment group to observed time to return of bowel function time
Relationship of AUC Cerebral Desaturations to Observed Time to Return of Bowel Function Time
时间窗: One year
Relationship of AUC cerebral desaturations to observed time to return of bowel function time
Relationship of AUC Cerebral Desaturations to Observed Time on Single Lung Ventilation
时间窗: One year
Relationship of AUC cerebral desaturations to observed time on single lung ventilation
Relationship of Assignment Group to Observed Use of Epidural Catheter
时间窗: One year
Relationship of assignment group to observed use of epidural catheter
Relationship of AUC Cerebral Desaturations to Observed Use of Epidural Catheter
时间窗: One year
Relationship of AUC cerebral desaturations to observed use of epidural catheter
Relationship of Assignment Group to Observed Post Anesthesia Care Unit Aldrete Score
时间窗: One year
Relationship of assignment group to observed post anesthesia care unit Aldrete score
Relationship of AUC Cerebral Desaturations to Observed Post Anesthesia Care Unit Aldrete Score
时间窗: One year
Relationship of AUC cerebral desaturations to observed post anesthesia care unit Aldrete score
Relationship of Assignment Group to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit
时间窗: One year
Relationship of assignment group to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit
Relationship of AUC Cerebral Desaturations to Observed Change in Renal Function From Baseline
时间窗: One year
Relationship of AUC cerebral desaturations to observed change in renal function from baseline
Relationship of AUC Cerebral Desaturations to Observed Time to Wean From Postoperative Supplemental Oxygen
时间窗: One year
Relationship of AUC cerebral desaturations to observed time to wean from postoperative supplemental oxygen
次要结局
- Assess the Frequency of Cerebral Desaturations in Both Cohorts by Examining Both the Total Number of Patients Experiencing Any Cerebral Desaturation as Well as the Total Number of Events Among Patients Experiencing Any Cerebral Desaturation.(one year)
- Adverse Clinical Events and Serious Adverse Events Overall and in Each Cohort(one year)
- Assess the Interventional Cohort's Preoperative Demographics and Collected Covariates for Association With the Ease or Difficulty of Mitigating Observed Cerebral Desaturation Events.(one year)
- Perform a Comprehensive Assessment of the Frequency and Efficacy of Predefined rSO2 Desaturation Mitigation Interventions and Their Collective Ability to Affect the Observed Cerebral Oximetry Values.(one year)