Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT03165539

Conditions

Delirium

Thoracic Surgery

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Cerebral oxygen saturation monitoring

Study Details

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.

Conditions

Delirium

Thoracic Surgery

Study ID

NCT03165539

Start date

Sep, 2015

Status verified date

Oct, 2018

Completion date

Feb, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Post-operative Delirium vs Cerebral Desaturation [ Time Frame: 5 days ]

Central Contacts and Locations

Central contacts

Stephen E Kowalski, MD

204-787-1414sekowalski@hsc.mb.ca

Linda Girling, BScHons

2047871414lgirling@hsc.mb.ca

Locations

Department of Anesthesia, University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0Z2

Contacts

Stephen Kowalski, MD

204-787-3796sekowalski@hsc.mb.ca

Linda Girling, BScHons

204-787-1414lgirling@hsc.mb.ca

More Information

Sponsor

University of Manitoba

Last update posted

Oct 16, 2018

Last verified

Oct, 2018

Keywords

  • Postoperative
  • One-lung ventilation
  • Cerebral oximetry
  • Cerebral desaturation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2018-10-16.