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Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT01866657
Recruitment Status : Unknown
Verified May 2013 by Edwin Avery, University Hospitals Cleveland Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Edwin Avery, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypoxia Drug: Vasoconstrictor Agents Other: Head/neck repositioning Other: Increase ETCO2 Other: IV fluid bolus Drug: Additional anesthesia Biological: RBC transfusion Drug: Increase FiO2 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: 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.
Drug: Vasoconstrictor Agents
cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion.
Other Name: phenylephrine, ephedrine, dopamine

Other: Head/neck repositioning
Assure that arterial and venous neck blood flow is not obstructed related to patient positioning
Other Name: neck repositioning

Other: Increase ETCO2
Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery
Other Name: Normalize end tidal CO2

Other: IV fluid bolus
Administer IV fluids to increase preload and cardiac output

Drug: Additional anesthesia
By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption.
Other Name: sevoflurane, propofol

Biological: RBC transfusion
By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity

Drug: Increase FiO2
Increase FiO2 to improve oxygen delivery to tissue
Other Name: Increase fractional concentration of inspired oxygen

No Intervention: Blinded cerebral oximetry monitoring
These subjects will have continous cerebral oximetry monitoring like the experimental cohort but the values will be blinded to all clinicians and research staff. There will be no cerebral desaturation interventions in this group because the clinicians will not be aware of a desaturation as the monitor's output is blinded in this group.



Primary Outcome Measures :
  1. 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. [ Time Frame: 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

  2. Relationship of assignment group to PACU length of stay. [ Time Frame: One year ]
    Relationship of assignment group (i.e. control vs intervention group) to PACU LOS

  3. Relationship of Area under the curve (AUC) of cerebral desaturations to PACU LOS [ Time Frame: One year ]
    Relationship of AUC of cerebral desats to PACU LOS

  4. Relationship of assignment group to Hospital length of stay (HLOS) [ Time Frame: One Year ]
    Relationship of assignment group (i.e. control vs intervention group) to HLOS

  5. Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS [ Time Frame: One year ]
    Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS

  6. Relationship of assignment group to ICU LOS [ Time Frame: One year ]
    Relationship of assignment group to ICU LOS

  7. Relationship of AUC cerebral desaturations to ICU LOS [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to ICU LOS

  8. Relationship of assignment group to AUC of mean arterial blood pressure [ Time Frame: One Year ]
    Relationship of assignment group to AUC of mean arterial blood pressure

  9. Relationship of AUC cerebral desaturations to AUC of mean arterial blood pressure [ Time Frame: One Year ]
    Relationship of AUC cerebral desaturations to AUC of mean arterial blood pressure

  10. Relationship of assignment group to observed intraoperative mLs urine/kg/hr [ Time Frame: One year ]
    Relationship of assignment group to observed intraoperative mLs urine/kg/hr

  11. Relationship of AUC cerebral desaturations to observed intraoperative mLs urine/kg/hr [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed intraoperative mLs urine/kg/hr

  12. Relationship of assignment group to transfusion of red blood cells [ Time Frame: One year ]
    Relationship of assignment group to transfusion of red blood cells

  13. Relationship of AUC cerebral desaturations to transfusion of red blood cells [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to transfusion of red blood cells

  14. Relationship of assignment group to observed frequency of any change in surgical procedure [ Time Frame: One year ]
    Relationship of assignment group to observed frequency of any change in surgical procedure

  15. Relationship of AUC cerebral desaturations to observed frequency of any change in surgical procedure [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency of any change in surgical procedure

  16. Relationship of assignment group to observed frequency of intraoperative or postoperative stroke [ Time Frame: One Year ]
    Relationship of assignment group to observed frequency of intraoperative or postoperative stroke

  17. Relationship of AUC cerebral desaturations to observed frequency of intraoperative or postoperative stroke [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency of intraoperative or postoperative stroke

  18. Relationship of assignment group to observed frequency of transient ischemic attack [ Time Frame: One year ]
    Relationship of assignment group to observed frequency of transient ischemic attack

  19. Relationship of AUC cerebral desaturations to observed frequency of transient ischemic attack [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency of transient ischemic attack

  20. Relationship of assignment group to observed frequency of myocardial infarction [ Time Frame: One year ]
    Relationship of assignment group to observed frequency of myocardial infarction

  21. Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction

  22. Relationship of assignment group to observed frequency of atrial fibrillation [ Time Frame: One year ]
    Relationship of assignment group to observed frequency of atrial fibrillation

  23. Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation

  24. Relationship of assignment group to observed frequency of AUC glucose > 110 mg/dL [ Time Frame: One year ]
    Relationship of assignment group to observed frequency of AUC glucose > 110 mg/dL

  25. Relationship of AUC cerebral desaturations to observed frequency of AUC glucose > 110 mg/dL [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency of AUC glucose > 110 mg/dL

  26. Relationship of assignment group to observed operating room time [ Time Frame: One year ]
    Relationship of assignment group to observed operating room time

  27. Relationship of AUC cerebral desaturations to observed operating room time [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed operating room time

  28. Relationship of assignment group to observed amount of narcotic administered in the operating room [ Time Frame: One year ]
    Relationship of assignment group to observed amount of narcotic administered in the operating room

  29. Relationship of AUC cerebral desaturations to observed amount of narcotic administered in the operating room [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed amount of narcotic administered in the operating room

  30. Relationship of assignment group to observed volume of crystalloid/colloid administered in the operating room [ Time Frame: One year ]
    Relationship of assignment group to observed volume of crystalloid/colloid administered in the operating room

  31. Relationship of AUC cerebral desaturations to observed volume of crystalloid/colloid administered in the operating room [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed volume of crystalloid/colloid administered in the operating room

  32. Relationship of assignment group to observed amount of anti-emetic meds administered in the operating room [ Time Frame: One year ]
    Relationship of assignment group to observed amount of anti-emetic meds administered in the operating room

  33. Relationship of AUC cerebral desaturations to observed amount of anti-emetic meds administered in the operating room [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed amount of anti-emetic meds administered in the operating room

  34. Relationship of assignment group to reported surgical procedure performed [ Time Frame: One year ]
    Relationship of assignment group to reported surgical procedure performed

  35. Relationship of AUC cerebral desaturations to reported surgical procedure performed [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to reported surgical procedure

  36. Relationship of assignment group to observed time on single lung ventilation [ Time Frame: One year ]
    Relationship of assignment group to observed time on single lung ventilation

  37. Relationship of AUC cerebral desaturations to observed time on single lung ventilation [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed time on single lung ventilation

  38. Relationship of assignment group to observed use of epidural catheter [ Time Frame: One year ]
    Relationship of assignment group to observed use of epidural catheter

  39. Relationship of AUC cerebral desaturations to observed use of epidural catheter [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed use of epidural catheter

  40. Relationship of assignment group to observed post anesthesia care unit Aldrete score [ Time Frame: One year ]
    Relationship of assignment group to observed post anesthesia care unit Aldrete score

  41. Relationship of AUC cerebral desaturations to observed post anesthesia care unit Aldrete score [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed post anesthesia care unit Aldrete score

  42. Relationship of assignment group to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit [ Time Frame: One year ]
    Relationship of assignment group to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit

  43. Relationship of AUC cerebral desaturations to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit

  44. Relationship of assignment group to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit [ Time Frame: One year ]
    Relationship of assignment group to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit

  45. Relationship of AUC cerebral desaturations to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit

  46. Relationship of assignment group to observed need for postoperative discharge to skilled nursing/rehabilitation facility [ Time Frame: One year ]
    Relationship of assignment group to observed need for postoperative discharge to skilled nursing/rehabilitation facility

  47. Relationship of AUC cerebral desaturations to observed need for postoperative discharge to skilled nursing/rehabilitation facility [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed need for postoperative discharge to skilled nursing/rehabilitation facility

  48. Relationship of assignment group to observed need for hospital readmission [ Time Frame: One year ]
    Relationship of assignment group to observed need for hospital readmission

  49. Relationship of AUC cerebral desaturations to observed need for hospital readmission [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed need for hospital readmission

  50. Relationship of assignment group to observed change in CAM or MMSE scores from baseline [ Time Frame: One year ]
    Relationship of assignment group to observed change in CAM or MMSE scores from baseline

  51. Relationship of AUC cerebral desaturations to observed change in CAM or MMSE scores from baseline [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed change in CAM or MMSE scores from baseline

  52. Relationship of assignment group to observed change in renal function from baseline [ Time Frame: One year ]
    Relationship of assignment group to observed change in renal function from baseline

  53. Relationship of AUC cerebral desaturations to observed change in renal function from baseline [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed change in renal function from baseline

  54. Relationship of assignment group to observed time to return of bowel function time [ Time Frame: One year ]
    Relationship of assignment group to observed time to return of bowel function time

  55. Relationship of AUC cerebral desaturations to observed time to return of bowel function time [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed time to return of bowel function time

  56. Relationship of group assignment to any observed postoperative infection [ Time Frame: One year ]
    Relationship of group assignment to any observed postoperative infection

  57. Relationship of AUC cerebral desaturations to any observed postoperative infection [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to any observed postoperative infection

  58. Relationship of assignment group to observed time to wean from postoperative supplemental oxygen [ Time Frame: One year ]
    Relationship of assignment group to observed time to wean from postoperative supplemental oxygen

  59. Relationship of AUC cerebral desaturations to observed time to wean from postoperative supplemental oxygen [ Time Frame: One year ]
    Relationship of AUC cerebral desaturations to observed time to wean from postoperative supplemental oxygen

  60. Relationship of assignment group to observed incidence of postop morbidity composite endpoint (defined in description section below) [ Time Frame: 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)

  61. Relationship of AUC cerebral desaturations to observed incidence of postoperative morbidity composite endpoint (defined in description section below) [ Time Frame: 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)


Secondary Outcome Measures :
  1. 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. [ Time Frame: one year ]
    Assess the frequency of cerebral desaturations in both the intervention and control 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.

  2. Adverse clinical events and serious adverse events overall and in each cohort [ Time Frame: one year ]
    Assess the frequency of adverse clinical events and serious adverse events overall and in each cohort

  3. 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. [ Time Frame: one year ]
    Perform a comprehensive assessment of the frequency and efficacy of predefined rSO2 desaturation mitigation interventions (e.g., increase MAP with IV vasoconstrictor or fluid bolus, normalize ETCO2, deepen anesthesia, etc.) and their collective ability to affect the observed cerebral oximetry values. This will allow determination of the average number of interventions required and those most commonly effective in mitigating desaturation.

  4. Assess the interventional cohort's preoperative demographics and collected covariates for association with the ease or difficulty of mitigating observed cerebral desaturation events. [ Time Frame: one year ]
    Because mitigating cerebral desaturations involves increasing oxygen delivery to the tissue it is possible that there is a relationship between preoperative demographic/variables such as age, peripheral vascular disease, left ventricular dysfunction, COPD, etc. and the ability to effectively mitigate desaturations in that subjects with disease in these organ systems may be more resistant to responding to desaturation interventions.


Other Outcome Measures:
  1. • Logistic regression analysis to determine the most relevant AUCrSO2 desaturation value(s) associated with any detrimental clinical outcome(s) monitored in this study [ Time Frame: one year ]
    Logistic regression analysis to determine the most relevant AUCrSO2 desaturation value(s) associated with any detrimental clinical outcome(s) monitored in this study

  2. Logistic regression analysis to determine the most relevant AUC blood pressure values associated with any detrimental clinical outcome(s) monitored in this study [ Time Frame: one year ]
    Logistic regression analysis to determine the most relevant AUC blood pressure values associated with any detrimental clinical outcome(s) monitored in this study

  3. Comparison of baseline rSO2 values (room air and oxygen supplemented) to all collected clinical variables to assess for possibly significant associations [ Time Frame: One year ]
    Comparison of baseline rSO2 values (room air and oxygen supplemented) to all collected clinical variables to assess for possibly significant associations

  4. Explore the potential impact of rSO2 monitoring on changing the surgical conduct of the procedure [ Time Frame: one year ]
    Explore the potential impact of rSO2 monitoring on changing the surgical conduct of the procedure



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Able to adequately complete a baseline mini-mental status examination (MMSE)
  3. Able to complete a baseline confusion assessment method (CAM) examination
  4. Able to obtain bi-frontal baseline rSO2 values prior to induction of anesthesia

Exclusion Criteria:

  1. Any patient who has participated in a clinical study of an investigational drug or device in the past 30 days
  2. Any patient who the principal investigator feels at any time or for any reason should not participate in this clinical study
  3. Withdrawal of informed consent for any reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866657


Contacts
Layout table for location contacts
Contact: Edwin G Avery, MD 216-844-7334 edwin.avery@uhhospitals.org
Contact: Nadine Norton, RN 216-513-9871 nadine.norton@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44126
Principal Investigator: John C Klick, MD         
Principal Investigator: Philip Linden, MD         
Sub-Investigator: Edwin G Avery, MD         
Sub-Investigator: James Rowbottom, MD         
Sub-Investigator: Andrew Plante, MD         
Sub-Investigator: Howard Nearman, MD, MBA         
Sub-Investigator: Nichol.as Pesa, MD         
Sub-Investigator: James D Reynolds, PhD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: John C Klick, MD University Hospitals Cleveland Medical Center
Study Director: Edwin G Avery, MD University Hospitals Cleveland Medical Center

Publications:
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Responsible Party: Edwin Avery, Co-Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01866657     History of Changes
Other Study ID Numbers: UHCMC-CEROX-01
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Edwin Avery, University Hospitals Cleveland Medical Center:
cerebral oximetry
randomized controlled pilot study
thoracic surgery
single lung ventilation

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Anesthetics
Phenylephrine
Vasoconstrictor Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents