Clinical trial NCT01835327: Cerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung Surgery
Official title: Cerebral Oximetry and Recovery Following Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Oxygen Desaturation
Keywords: intraoperative, post-operative recovery
thoracic surgery
cerebral oximetry
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anticipated inclusion is all patients scheduled for thoracic surgery at Mount Sinai Hospital by the aforementioned surgeons Dr. Flores and Dr. Kaufman. Exclusion criteria will be those patients who (1) do not speak English, (2) are less that the age of 18 years old, (3) are currently prisoners, (4) do not display the capacity to consent to the trial and (5) who are unwilling to complete the study. Screening for exclusion criteria will occur primarily in the pre-operative setting under the guidance of Drs. Flores and Kaufman and will be reviewed by the Research Coordinator and acting anesthesiologist on the day of surgery.

Brief summary: The current study proposes to address the question of whether patients' cerebral oxygen saturation levels are predictive of their recovery from thoracic surgery. Further, the study poses the hypothesis that a patient's poor recovery status goes on to increase a patient's risk of developing post-operative morbidities such as pneumonia, arrhythmias and delirium. The aim of this study is to address the observation that some patients struggle more than others in their recovery and that 1) this may be a result of intraoperative cerebral oxygen desaturations and 2) that this may affect their post-operative morbidity. If a potential means of predicting poor outcomes is identified this will lead to further research into how to adjust the associated variables, such as cerebral oxygenation, to improve patient post-operative outcome.

Detailed description: Despite advances in the field of thoracic surgery, post-operative morbidity continues to be a significant problem with limited understanding of the connection between the insult of surgery and anesthesia and the pathophysiology of the development of these morbidities. Surgeons in the thoracic department have noted that some patients seem to recover less vigorously than other patients. What accounts for these different recovery trajectories is unclear. Researchers have developed a Post-Operative Quality Recovery Scale (PQRS) which assesses six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient experience) and has been suggested to serve as a means of tracking patients' recovery from surgery.

Eligibility criteria: Inclusion Criteria:

* speak English
* 18 yo or older
* willing to participate
* undergoing thoracic surgery at Mount Sinai Hospital that will require one lung ventilation

Exclusion Criteria:

* prisoners
* lack capacity to consent to trial

Primary outcomes:
measure: Post-Operative Quality of Recovery Score (PQRS)
timeFrame: up to 3 months
measure: Post-Operative Morbidity Survey (POMS) Score
timeFrame: Post-Operative day 3
measure: Post-Operative Morbidity Survey (POMS) Score
timeFrame: Post-Operative day 5
measure: Post-Operative Morbidity Survey (POMS) Score
timeFrame: Post-Operative day 8
Secondary outcomes:
measure: Cognitive Assessment Method
timeFrame: up to 14 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffrey Silverstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Monique Roberts, BA
role: STUDY_DIRECTOR
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