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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
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.
Details
| Lead sponsor | University Hospitals Cleveland Medical Center |
|---|---|
| Phase | NA |
| Status | TERMINATED |
| Enrolment | 74 |
| Start date | 2013-06 |
| Completion | 2016-11-10 |
Conditions
- Hypoxia
Interventions
- Vasoconstrictor Agents
- Head/neck repositioning
- Increase ETCO2
- IV fluid bolus
- Additional anesthesia
- RBC transfusion
- Increase FiO2
Primary outcomes
- 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. — 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 PACU Length of Stay. — One year
Relationship of assignment group (i.e. control vs intervention group) to PACU LOS - Relationship of Area Under the Curve (AUC) of Cerebral Desaturations to PACU LOS — One year
Relationship of AUC of cerebral desats to PACU LOS - Relationship of Assignment Group to Hospital Length of Stay (HLOS) — 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 — One year
Relationship of Area under the curve (AUC) of cerebral desaturations to HLOS - Relationship of Assignment Group to ICU LOS — One year
Relationship of assignment group to ICU LOS
Countries
United States