Cerebral Oxygen DesaturationNCT01835327
Cerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung Surgery
An observational study of Cerebral Oxygen Desaturation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygen Desaturation
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- speak English
- 18 yo or older
- willing to participate
- undergoing thoracic surgery at Mount Sinai Hospital that will require one lung ventilation
Who cannot join
- prisoners
- lack capacity to consent to trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Cerebral Oximetry and Recovery Following Thoracic Surgery
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.
Read the 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.
- Conditions
- Cerebral Oxygen Desaturation
- Keywords
- intraoperative, post-operative recovery, thoracic surgery, cerebral oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Quality of Recovery Score (PQRS)
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.
Measured: up to 3 months
Post-Operative Morbidity Survey (POMS) Score
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.
Measured: Post-Operative day 3
Post-Operative Morbidity Survey (POMS) Score
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.
Measured: Post-Operative day 5
Post-Operative Morbidity Survey (POMS) Score
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.
Measured: Post-Operative day 8
Secondary outcomes (1)
Cognitive Assessment Method
Also measuring delirium each day of hospitalization POD1-POD14 via modified and validated version of the CAM (Cognitive Assessment Method).
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: PI no longer at institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Cerebral Oxygen DesaturationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Silverstein, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMonique Roberts, BA, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835327
- Sponsor's protocol ID
- GCO 12-1398
- Other IDs
- HS#: 12-00716
- Status last verified
- Feb 2017
- First submitted
- 16 Apr 2013
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
PubMed 20601860Daubeney PE, Pilkington SN, Janke E, Charlton GA, Smith DC, Webber SA. Cerebral oxygenation measured by near-infrared spectroscopy: comparison with jugular bulb oximetry. Ann Thorac Surg. 1996 Mar;61(3):930-4. doi: 10.1016/0003-4975(95)01186-2.
PubMed 8619720Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E376-81. doi: 10.1532/HSF98.20041062.
PubMed 15799908Murkin 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.
PubMed 17179242Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
PubMed 19101265Hemmerling TM, Bluteau MC, Kazan R, Bracco D. Significant decrease of cerebral oxygen saturation during single-lung ventilation measured using absolute oximetry. Br J Anaesth. 2008 Dec;101(6):870-5. doi: 10.1093/bja/aen275. Epub 2008 Oct 3.
PubMed 18835887Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
PubMed 10439777Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.
PubMed 17689808Ackland GL, Harris S, Ziabari Y, Grocott M, Mythen M; SOuRCe Investigators. Revised cardiac risk index and postoperative morbidity after elective orthopaedic surgery: a prospective cohort study. Br J Anaesth. 2010 Dec;105(6):744-52. doi: 10.1093/bja/aeq245. Epub 2010 Sep 28.
PubMed 20876700Ackland GL, Moran N, Cone S, Grocott MP, Mythen MG. Chronic kidney disease and postoperative morbidity after elective orthopedic surgery. Anesth Analg. 2011 Jun;112(6):1375-81. doi: 10.1213/ANE.0b013e3181ee8456. Epub 2010 Aug 31.
PubMed 20807976Hollowell J, Grocott MP, Hardy R, Haddad FS, Mythen MG, Raine R. Major elective joint replacement surgery: socioeconomic variations in surgical risk, postoperative morbidity and length of stay. J Eval Clin Pract. 2010 Jun;16(3):529-38. doi: 10.1111/j.1365-2753.2009.01154.x. Epub 2010 Feb 18.
PubMed 20210822Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3.
PubMed 21048092Grichnik KP, Ijsselmuiden AJ, D'Amico TA, Harpole DH Jr, White WD, Blumenthal JA, Newman MF. Cognitive decline after major noncardiac operations: a preliminary prospective study. Ann Thorac Surg. 1999 Nov;68(5):1786-91. doi: 10.1016/s0003-4975(99)00992-3.
PubMed 10585059Murkin JM. Cerebral oximetry: monitoring the brain as the index organ. Anesthesiology. 2011 Jan;114(1):12-3. doi: 10.1097/ALN.0b013e3181fef5d2. No abstract available.
PubMed 21178667Tang 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.
PubMed 22311364
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oximetry and Recovery Following Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01835327
- Acronym / sponsor ID
- GCO 12-1398
- Conditions
- Cerebral Oxygen Desaturation
- Keywords
- intraoperative, post-operative recovery, thoracic surgery, cerebral oximetry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI no longer at institution
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- speak English
- 18 yo or older
- willing to participate
- undergoing thoracic surgery at Mount Sinai Hospital that will require one lung ventilation
Key exclusion criteria (2 listed)
- prisoners
- lack capacity to consent to trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-Operative Quality of Recovery Score (PQRS)
Time frame: up to 3 months
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
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
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
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.
1 secondary outcome
Cognitive Assessment Method
Time frame: up to 14 days
Results and safety
The study was stopped early (reason given: PI no longer at institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 20601860Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
- Background: PubMed 8619720Daubeney PE, Pilkington SN, Janke E, Charlton GA, Smith DC, Webber SA. Cerebral oxygenation measured by near-infrared spectroscopy: comparison with jugular bulb oximetry. Ann Thorac Surg. 1996 Mar;61(3):930-4. doi: 10.1016/0003-4975(95)01186-2.
- Background: PubMed 15799908Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. Heart Surg Forum. 2004;7(5):E376-81. doi: 10.1532/HSF98.20041062.
- Background: PubMed 17179242Murkin 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.
- Background: PubMed 19101265Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
- Background: PubMed 18835887Hemmerling TM, Bluteau MC, Kazan R, Bracco D. Significant decrease of cerebral oxygen saturation during single-lung ventilation measured using absolute oximetry. Br J Anaesth. 2008 Dec;101(6):870-5. doi: 10.1093/bja/aen275. Epub 2008 Oct 3.
- Background: PubMed 10439777Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.
- Background: PubMed 17689808Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.
- Background: PubMed 20876700Ackland GL, Harris S, Ziabari Y, Grocott M, Mythen M; SOuRCe Investigators. Revised cardiac risk index and postoperative morbidity after elective orthopaedic surgery: a prospective cohort study. Br J Anaesth. 2010 Dec;105(6):744-52. doi: 10.1093/bja/aeq245. Epub 2010 Sep 28.
- Background: PubMed 20807976Ackland GL, Moran N, Cone S, Grocott MP, Mythen MG. Chronic kidney disease and postoperative morbidity after elective orthopedic surgery. Anesth Analg. 2011 Jun;112(6):1375-81. doi: 10.1213/ANE.0b013e3181ee8456. Epub 2010 Aug 31.
- Background: PubMed 20210822Hollowell J, Grocott MP, Hardy R, Haddad FS, Mythen MG, Raine R. Major elective joint replacement surgery: socioeconomic variations in surgical risk, postoperative morbidity and length of stay. J Eval Clin Pract. 2010 Jun;16(3):529-38. doi: 10.1111/j.1365-2753.2009.01154.x. Epub 2010 Feb 18.
- Background: PubMed 21048092Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3.
Related trials for Cerebral Oxygen Desaturation
Not yet recruitingObservational study
Cerebral Oximetry During Awake Carotid Endarterectomy
Carotid Stenosis, Carotid Artery Diseases
Not yet recruitingPhase 3
Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
Cerebral Desaturation Events, Spine Surgeries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Silverstein, MD principal investigator
Icahn School of Medicine at Mount Sinai
Monique Roberts, BA study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygen Desaturation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI no longer at institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Quality of Recovery Score (PQRS) (time frame: up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01835327, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.