Cerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01835327
First received: April 16, 2013
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition
Cerebral Oxygen Desaturation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cerebral Oximetry and Recovery Following Thoracic Surgery

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Post-Operative Quality of Recovery Score (PQRS) [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
    Patients are assessed 30 minutes, one hour, and three hours post extubation time on day of surgery and then once daily for however long they are hospitalized up to 14 days, patients are then assessed via phone at one month and three months post-op. Recovery is assessed via questions on multiple domains such as pain and nausea, emotional status, activities of daily living and cognitive status.

  • Post-Operative Morbidity Survey (POMS) Score [ Time Frame: Post-Operative day 3 ] [ Designated as safety issue: No ]
    The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.

  • Post-Operative Morbidity Survey (POMS) Score [ Time Frame: Post-Operative day 5 ] [ Designated as safety issue: No ]
    The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.

  • Post-Operative Morbidity Survey (POMS) Score [ Time Frame: Post-Operative day 8 ] [ Designated as safety issue: No ]
    The POMS score measures morbidity across multiple categories with pre-defined thresholds, example: Pulmonary (de novo requirement of oxygen supplementation), Infectious (fever above 38C or require antibiotics) etc.


Secondary Outcome Measures:
  • Cognitive Assessment Method [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
    Also measuring delirium each day of hospitalization POD1-POD14 via modified and validated version of the CAM (Cognitive Assessment Method).


Estimated Enrollment: 130
Study Start Date: September 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposed
Cerebral oximetry desaturation below 65% for a minimum of 3 minutes
Not Exposed
Those patients who do not experience a cerebral oxygen desaturation below 65% for a minimum of 3 minutes

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835327

Contacts
Contact: Monique L Roberts, BA 240-529-4808 monique.roberts@mssm.edu
Contact: Jeffrey Silverstein, MD 212-659-8980 jeff.silverstein@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Gregory Fischer, MD    212-241-7467    gregory.fischer@mountsinai.org   
Contact: Raja Flores, MD    212-241-4404    raja.flores@mountsinai.org   
Principal Investigator: Jeffrey Silverstein, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Jeffrey Silverstein, MD Mount Sinai School of Medicine
Study Director: Monique Roberts, BA Mount Sinai School of Medicine
  More Information

Publications:

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01835327     History of Changes
Other Study ID Numbers: GCO 12-1398, HS#: 12-00716
Study First Received: April 16, 2013
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
intraoperative, post-operative recovery
thoracic surgery
cerebral oximetry

ClinicalTrials.gov processed this record on August 20, 2014