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

• Conditions: Thoracic Surgery; Delirium
• Interventions: Device: Cerebral oxygen saturation monitoring

• Registration Number: NCT03165539
• Lead Sponsor: University of Manitoba

Brief 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.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Inability to communicate in English
• Lack of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracic surgery patient	Cerebral oxygen saturation monitoring	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.

Primary Outcome Measures

Name	Time	Method
Post-operative Delirium vs Cerebral Desaturation	5 days	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)

Trial Locations

Locations (1)

Department of Anesthesia, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada