Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

NCT01866657 | Terminated Results DMC

• 1 other identifier: UHCMC-CEROX-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

cerebral oximetry; randomized controlled pilot study; thoracic surgery; single lung ventilation

Outcome Measures

Primary Outcomes (61)

• 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.

  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

  One year

• Relationship of Assignment Group to PACU Length of Stay.

  Relationship of assignment group (i.e. control vs intervention group) to PACU LOS

  One year

• Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to PACU LOS

  Relationship of AUC of cerebral desats to PACU LOS

  One year

• Relationship of Assignment Group to Hospital Length of Stay (HLOS)

  Relationship of assignment group (i.e. control vs intervention group) to HLOS

  One Year

• Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to HLOS

  Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS

  One year

• Relationship of Assignment Group to ICU LOS

  Relationship of assignment group to ICU LOS

  One year

• Relationship of AUC Cerebral Desaturations to ICU LOS

  Relationship of AUC cerebral desaturations to ICU LOS

  One year

• Relationship of Assignment Group to AUC of Mean Arterial Blood Pressure

  Relationship of assignment group to AUC of mean arterial blood pressure

  One Year

• Relationship of AUC Cerebral Desaturations to AUC of Mean Arterial Blood Pressure

  Relationship of AUC cerebral desaturations to AUC of mean arterial blood pressure

  One Year

• Relationship of Assignment Group to Observed Intraoperative mLs Urine/kg/hr

  Relationship of assignment group to observed intraoperative mLs urine/kg/hr

  One year

• Relationship of AUC Cerebral Desaturations to Observed Intraoperative mLs Urine/kg/hr

  Relationship of AUC cerebral desaturations to observed intraoperative mLs urine/kg/hr

  One year

• Relationship of Assignment Group to Transfusion of Red Blood Cells

  Relationship of assignment group to transfusion of red blood cells

  One year

• Relationship of AUC Cerebral Desaturations to Transfusion of Red Blood Cells

  Relationship of AUC cerebral desaturations to transfusion of red blood cells

  One year

• Relationship of Assignment Group to Observed Frequency of Any Change in Surgical Procedure

  Relationship of assignment group to observed frequency of any change in surgical procedure

  One year

• Relationship of AUC Cerebral Desaturations to Observed Frequency of Any Change in Surgical Procedure

  Relationship of AUC cerebral desaturations to observed frequency of any change in surgical procedure

  One year

• Relationship of Assignment Group to Observed Frequency of Intraoperative or Postoperative Stroke

  Relationship of assignment group to observed frequency of intraoperative or postoperative stroke

  One Year

• Relationship of AUC Cerebral Desaturations to Observed Frequency of Intraoperative or Postoperative Stroke

  Relationship of AUC cerebral desaturations to observed frequency of intraoperative or postoperative stroke

  One year

• Relationship of Assignment Group to Observed Frequency of Transient Ischemic Attack

  Relationship of assignment group to observed frequency of transient ischemic attack

  One year

• Relationship of AUC Cerebral Desaturations to Observed Frequency of Transient Ischemic Attack

  Relationship of AUC cerebral desaturations to observed frequency of transient ischemic attack

  One year

• Relationship of Assignment Group to Observed Frequency of Myocardial Infarction

  Relationship of assignment group to observed frequency of myocardial infarction

  One year

• Relationship of AUC Cerebral Desaturations to Observed Frequency of Myocardial Infarction

  Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction

  One year

• Relationship of Assignment Group to Observed Frequency of Atrial Fibrillation

  Relationship of assignment group to observed frequency of atrial fibrillation

  One year

• Relationship of AUC Cerebral Desaturations to Observed Frequency of Atrial Fibrillation

  Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation

  One year

• Relationship of Assignment Group to Observed Frequency of AUC Glucose > 110 mg/dL

  Relationship of assignment group to observed frequency of AUC glucose \> 110 mg/dL

  One year

• Relationship of AUC Cerebral Desaturations to Observed Frequency of AUC Glucose > 110 mg/dL

  Relationship of AUC cerebral desaturations to observed frequency of AUC glucose \> 110 mg/dL

  One year

• Relationship of Assignment Group to Observed Operating Room Time

  Relationship of assignment group to observed operating room time

  One year

• Relationship of AUC Cerebral Desaturations to Observed Operating Room Time

  Relationship of AUC cerebral desaturations to observed operating room time

  One year

• Relationship of Assignment Group to Observed Amount of Narcotic Administered in the Operating Room

  Relationship of assignment group to observed amount of narcotic administered in the operating room

  One year

• Relationship of AUC Cerebral Desaturations to Observed Amount of Narcotic Administered in the Operating Room

  Relationship of AUC cerebral desaturations to observed amount of narcotic administered in the operating room

  One year

• Relationship of Assignment Group to Observed Volume of Crystalloid/Colloid Administered in the Operating Room

  Relationship of assignment group to observed volume of crystalloid/colloid administered in the operating room

  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 volume of crystalloid/colloid administered in the operating room

  One year

• Relationship of Assignment Group to Observed Amount of Anti-emetic Meds Administered in the Operating Room

  Relationship of assignment group to observed amount of anti-emetic meds administered in the operating room

  One year

• Relationship of AUC Cerebral Desaturations to Observed Amount of Anti-emetic Meds Administered in the Operating Room

  Relationship of AUC cerebral desaturations to observed amount of anti-emetic meds administered in the operating room

  One year

• Relationship of Assignment Group to Reported Surgical Procedure Performed

  Relationship of assignment group to reported surgical procedure performed

  One year

• Relationship of AUC Cerebral Desaturations to Reported Surgical Procedure Performed

  Relationship of AUC cerebral desaturations to reported surgical procedure

  One year

• Relationship of Assignment Group to Observed Time on Single Lung Ventilation

  Relationship of assignment group to observed time on single lung ventilation

  One year

• Relationship of AUC Cerebral Desaturations to Observed Time on Single Lung Ventilation

  Relationship of AUC cerebral desaturations to observed time on single lung ventilation

  One year

• Relationship of Assignment Group to Observed Use of Epidural Catheter

  Relationship of assignment group to observed use of epidural catheter

  One year

• Relationship of AUC Cerebral Desaturations to Observed Use of Epidural Catheter

  Relationship of AUC cerebral desaturations to observed use of epidural catheter

  One year

• Relationship of Assignment Group to Observed Post Anesthesia Care Unit Aldrete Score

  Relationship of assignment group to observed post anesthesia care unit Aldrete score

  One year

• Relationship of AUC Cerebral Desaturations to Observed Post Anesthesia Care Unit Aldrete Score

  Relationship of AUC cerebral desaturations to observed post anesthesia care unit Aldrete score

  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 assignment group to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit

  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 AUC cerebral desaturations to observed frequency and severity of nausea/vomiting in the post anesthesia care unit/intensive care unit

  One year

• Relationship of Assignment Group to Observed Duration of Mechanical Ventilation in the Post Anesthesia Care Unit/Intensive Care Unit

  Relationship of assignment group to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit

  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 duration of mechanical ventilation in the post anesthesia care unit/intensive care unit

  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 postoperative discharge to skilled nursing/rehabilitation facility

  One year

• Relationship of AUC Cerebral Desaturations to Observed Need for Postoperative Discharge to Skilled Nursing/Rehabilitation Facility

  Relationship of AUC cerebral desaturations to observed need for postoperative discharge to skilled nursing/rehabilitation facility

  One year

• Relationship of Assignment Group to Observed Need for Hospital Readmission

  Relationship of assignment group to observed need for hospital readmission

  One year

• Relationship of AUC Cerebral Desaturations to Observed Need for Hospital Readmission

  Relationship of AUC cerebral desaturations to observed need for hospital readmission

  One year

• Relationship of Assignment Group to Observed Change in CAM or MMSE Scores From Baseline

  Relationship of assignment group to observed change in CAM or MMSE scores from baseline

  One year

• Relationship of AUC Cerebral Desaturations to Observed Change in CAM or MMSE Scores From Baseline

  Relationship of AUC cerebral desaturations to observed change in CAM or MMSE scores from baseline

  One year

• Relationship of Assignment Group to Observed Change in Renal Function From Baseline

  Relationship of assignment group to observed change in renal function from baseline

  One year

• Relationship of AUC Cerebral Desaturations to Observed Change in Renal Function From Baseline

  Relationship of AUC cerebral desaturations to observed change in renal function from baseline

  One year

• Relationship of Assignment Group to Observed Time to Return of Bowel Function Time

  Relationship of assignment group to observed time to return of bowel function time

  One year

• Relationship of AUC Cerebral Desaturations to Observed Time to Return of Bowel Function Time

  Relationship of AUC cerebral desaturations to observed time to return of bowel function time

  One year

• Relationship of Group Assignment to Any Observed Postoperative Infection

  Relationship of group assignment to any observed postoperative infection

  One year

• Relationship of AUC Cerebral Desaturations to Any Observed Postoperative Infection

  Relationship of AUC cerebral desaturations to any observed postoperative infection

  One year

• Relationship of Assignment Group to Observed Time to Wean From Postoperative Supplemental Oxygen

  Relationship of assignment group to observed time to wean from postoperative supplemental oxygen

  One year

• Relationship of AUC Cerebral Desaturations to Observed Time to Wean From Postoperative Supplemental Oxygen

  Relationship of AUC cerebral desaturations to observed time to wean from postoperative supplemental oxygen

  One year

• Relationship of Assignment Group to Observed Incidence of Postop Morbidity Composite Endpoint (Defined in Description Section Below)

  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)

  One year

• Relationship of AUC Cerebral Desaturations to Observed Incidence of Postoperative Morbidity Composite Endpoint (Defined in Description Section Below)

  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)

  One year

Secondary Outcomes (4)

• 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

• 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

• 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

Other Outcomes (4)

• • Logistic Regression Analysis to Determine the Most Relevant AUCrSO2 Desaturation Value(s) Associated With Any Detrimental Clinical Outcome(s) Monitored in This Study

  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

  one year

• Comparison of Baseline rSO2 Values (Room Air and Oxygen Supplemented) to All Collected Clinical Variables to Assess for Possibly Significant Associations

  One year

Study Arms (2)

Intervention cohort

EXPERIMENTAL

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; Other: Head/neck repositioning; Other: Increase ETCO2; Other: IV fluid bolus; Drug: Additional anesthesia; Biological: RBC transfusion; Drug: Increase FiO2

Blinded cerebral oximetry monitoring

NO INTERVENTION

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.

Interventions

Vasoconstrictor Agents DRUG

cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion.

Also known as: phenylephrine, ephedrine, dopamine

Intervention cohort

Head/neck repositioning OTHER

Assure that arterial and venous neck blood flow is not obstructed related to patient positioning

Also known as: neck repositioning

Intervention cohort

Increase ETCO2 OTHER

Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery

Also known as: Normalize end tidal CO2

Intervention cohort

IV fluid bolus OTHER

Administer IV fluids to increase preload and cardiac output

Intervention cohort

Additional anesthesia DRUG

By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption.

Also known as: sevoflurane, propofol

Intervention cohort

RBC transfusion BIOLOGICAL

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

Intervention cohort

Increase FiO2 DRUG

Increase FiO2 to improve oxygen delivery to tissue

Also known as: Increase fractional concentration of inspired oxygen

Intervention cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44126, United States

Location

Related Publications (4)

• Avery EG. Cerebral oximetry is frequently a "first alert" indicator of adverse outcomes. White paper. October 2010. http://www.somanetics.com/images/stories/pdfs/white-paper-series.pdf Last accessed 08-05-2012

  BACKGROUND

• Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G; Collaborative Italian Study Group on Anesthesia in Elderly Patients. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-747. doi: 10.1213/01.ane.0000166974.96219.cd.

  PMID: 16115985 BACKGROUND

• Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

  PMID: 17179242 BACKGROUND

• Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.

  PMID: 22311364 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Vasoconstrictor Agents; Phenylephrine; Ephedrine; Dopamine; Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Propanolamines; Propanols; Phenethylamines; Ethylamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Dr. Edwin Avery
• Organization: University Hospitals Cleveland Medical Center

Edwin.avery@uhhospitals.org

440-391-0690

Study Officials

• John C Klick, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Edwin G Avery, MD

  University Hospitals Cleveland Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2013
• First Posted: May 31, 2013
• Study Start: June 1, 2013
• Primary Completion: November 10, 2016
• Study Completion: November 10, 2016
• Last Updated: July 5, 2022
• Results First Posted: July 5, 2022

Record last verified: 2022-07

Locations

US (1)