- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165539
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
The Effect of Intraoperative Cerebral Oxygen Desaturation on Post-Operative Delirium in Thoracic Surgical Patients: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This will be a prospective, observational study on 200 patients. Consenting thoracic surgical patients presenting for open thoracotomy or VATS will be assessed pre-operatively for baseline cognitive status and clinically relevant risk factors for delirium. Intra-operatively, patients will undergo cerebral oxygenation monitoring using near infra-red spectroscopy cerebral oximetry. Postoperatively, patients will be assessed twice daily for the presence or absence of delirium using the Confusion Assessment Methodology (CAM) scoring system during their hospital stay.
A clinically relevant desaturation will be defined as a 25% decrease from the patient's baseline saturation, which will be determined while the patient is breathing room air pre-operatively. The severity and duration of any desaturation will be recorded and subsequently analyzed for correlation with post-operative delirium. Bivariate associations between the risk of delirium and predictor variables will be sought. If appropriate, logistic regression models will be constructed with the outcome of delirium.
Significance: Previous studies at our centre have resulted in over 35% of thoracic surgical patients developing significant, intra-operative cerebral desaturation. We propose to study a convenience sample of 200 consecutive patients. Depending on the relative risk of developing delirium with a significant cerebral desaturation, this study may be adequately powered to determine the associated risk of delirium. This study will provide background information in planning further interventional trials to prevent desaturation and possibly reduce the incidence of delirium, as well as aid in the planning of larger multi-center trials to more accurately assess the risk of intra-operative decreases in cerebral oxygenation and the role this event contributes to the occurrence of delirium.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stephen E Kowalski, MD
- Phone Number: 204-787-1414
- Email: sekowalski@hsc.mb.ca
Study Contact Backup
- Name: Linda Girling, BScHons
- Phone Number: 2047871414
- Email: lgirling@hsc.mb.ca
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0Z2
- Recruiting
- Department of Anesthesia, University of Manitoba
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Contact:
- Stephen Kowalski, MD
- Phone Number: 204-787-3796
- Email: sekowalski@hsc.mb.ca
-
Contact:
- Linda Girling, BScHons
- Phone Number: 204-787-1414
- Email: lgirling@hsc.mb.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing a thoracic surgical procedure with one-lung ventilation.
Exclusion Criteria:
- Inability to communicate in English
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Thoracic surgery patient
Pre-operatively, patients will have baseline cognitive assessment done using the Mini-mental status test and MOCA test.
Intra-operatively patients' baseline cerebral saturation (%) will be measured, and continuously monitored throughout the procedure.
Post-operatively, patients will be assessed for delirium using the CAM score.
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Intraoperatively, patients will have baseline cerebral oxygen saturation monitoring while breathing room air.
Cerebral oxygen saturation monitoring will continue throughout the entire operation including the time on one-lung ventilation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Delirium vs Cerebral Desaturation
Time Frame: 5 days
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Incidence of delirium will be assessed post-operatively up to POD 5 as measured by positive Confusion Assessment Method (CAM) scores and correlated with clinically relevant cerebral desaturation (greater than a 25% decrease from baseline)
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5 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eric Jacobsohn, MD, University of Manitoba
Publications and helpful links
General Publications
- Vasilevskis EE, Han JH, Hughes CG, Ely EW. Epidemiology and risk factors for delirium across hospital settings. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):277-87. doi: 10.1016/j.bpa.2012.07.003.
- Berry MF, Onaitis MW, Tong BC, Harpole DH, D'Amico TA. A model for morbidity after lung resection in octogenarians. Eur J Cardiothorac Surg. 2011 Jun;39(6):989-94. doi: 10.1016/j.ejcts.2010.09.038. Epub 2011 Jan 26.
- Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.
- Suehiro K, Okutai R. Duration of cerebral desaturation time during single-lung ventilation correlates with mini mental state examination score. J Anesth. 2011 Jun;25(3):345-9. doi: 10.1007/s00540-011-1136-1. Epub 2011 Apr 12.
- Tang 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2013:084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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