Trial Outcomes & Findings for Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery (NCT NCT01866657)

NCT ID: NCT01866657

Last Updated: 2022-07-05

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: One year
• Results posted on: 2022-07-05

Participant Flow

Participant milestones

Measure	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. Vasoconstrictor Agents: cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion. Head/neck repositioning: Assure that arterial and venous neck blood flow is not obstructed related to patient positioning Increase ETCO2: Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery IV fluid bolus: Administer IV fluids to increase preload and cardiac output Additional anesthesia: By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption. RBC transfusion: By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity Increase FiO2: Increase FiO2 to improve oxygen delivery to tissue	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.
Overall Study STARTED	38	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	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. Vasoconstrictor Agents: cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion. Head/neck repositioning: Assure that arterial and venous neck blood flow is not obstructed related to patient positioning Increase ETCO2: Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery IV fluid bolus: Administer IV fluids to increase preload and cardiac output Additional anesthesia: By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption. RBC transfusion: By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity Increase FiO2: Increase FiO2 to improve oxygen delivery to tissue	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.
Overall Study Surgery canceled	2	0

Baseline Characteristics

Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

Baseline characteristics by cohort

Measure	Intervention Cohort n=38 Participants 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. Vasoconstrictor Agents: cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion. Head/neck repositioning: Assure that arterial and venous neck blood flow is not obstructed related to patient positioning Increase ETCO2: Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery IV fluid bolus: Administer IV fluids to increase preload and cardiac output Additional anesthesia: By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption. RBC transfusion: By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity Increase FiO2: Increase FiO2 to improve oxygen delivery to tissue	Blinded Cerebral Oximetry Monitoring n=36 Participants 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.	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC of cerebral desats to PACU LOS

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One Year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to ICU LOS

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to ICU LOS

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One Year

Population: Data not collected

Relationship of assignment group to AUC of mean arterial blood pressure

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One Year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to transfusion of red blood cells

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to transfusion of red blood cells

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One Year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed frequency of transient ischemic attack

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed frequency of myocardial infarction

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed frequency of myocardial infarction

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed frequency of atrial fibrillation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed frequency of atrial fibrillation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed operating room time

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed operating room time

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed volume of crystalloid/colloid administered in the operating room

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to reported surgical procedure performed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to reported surgical procedure

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed time on single lung ventilation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed use of epidural catheter

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed use of epidural catheter

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed duration of mechanical ventilation in the post anesthesia care unit/intensive care unit

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed need for postoperative discharge to skilled nursing/rehabilitation facility

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of assignment group to observed need for hospital readmission

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to observed need for hospital readmission

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of group assignment to any observed postoperative infection

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

Relationship of AUC cerebral desaturations to any observed postoperative infection

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Data not collected

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Population: Data not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Population: Data not collected

Assess the frequency of adverse clinical events and serious adverse events overall and in each cohort

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Population: Data not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Population: Data not collected

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

Population: Data not collected

Logistic regression analysis to determine the most relevant AUCrSO2 desaturation value(s) associated with any detrimental clinical outcome(s) monitored in this study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

Population: Data not collected

Logistic regression analysis to determine the most relevant AUC blood pressure values associated with any detrimental clinical outcome(s) monitored in this study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: One year

Population: Data not collected

Comparison of baseline rSO2 values (room air and oxygen supplemented) to all collected clinical variables to assess for possibly significant associations

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: one year

Population: Data not collected

Explore the potential impact of rSO2 monitoring on changing the surgical conduct of the procedure

Outcome measures

Outcome data not reported

Adverse Events

Intervention Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Blinded Cerebral Oximetry Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Edwin Avery

University Hospitals Cleveland Medical Center

Phone: 440-391-0690

Email: Edwin.avery@uhhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place