Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients

Delirium Clinical Trial

Official title:

The Effect of Intraoperative Cerebral Oxygen Desaturation on Post-Operative Delirium in Thoracic Surgical Patients: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03165539
• Other study ID #: B2013:084
• Status: Recruiting
• Start date: September 2015
• Est. completion date: February 2019

Study information

• Verified date: October 2018
• Source: University of Manitoba
• Contact: Stephen E Kowalski, MD
• Phone: 204-787-1414
• Email: sekowalski[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will assess the incidence and risk factors for post-operative delirium in patients undergoing thoracotomy. Specifically, the study will assess if there is any relationship between an intra-operative decrease in brain oxygen levels which can occur during one-lung ventilation, and the occurrence of delirium in the post-operative period.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergoing a thoracic surgical procedure with one-lung ventilation.

Exclusion Criteria:

• Inability to communicate in English

• Lack of informed consent

Related Conditions & MeSH terms

• Delirium
• Thoracic Surgery

Intervention

Device:
• Cerebral oxygen saturation monitoring
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.

Locations

Country	Name	City	State
Canada	Department of Anesthesia, University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Delirium vs Cerebral Desaturation	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)	5 days