Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

Completed

• Conditions: Thoracic Surgery; Cognitive Dysfunction

• Registration Number: NCT03805880
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

The purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (POCD) in patients undergoing lung resection.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-03-31
• Study Completion: 2018-07-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-12
• Last Update Submitted: 2019-01-12
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients scheduled for elective lobectomy or wedge resection via thoracotomy
• one lung ventilation (OLV duration) ≥ 45 min

Exclusion Criteria

• previous cerebral disease,
• dementia,
• severe cognitive dysfunction
• emergency surgery
• pregnancy
• patient refusal to give consent
• inability to give consent
• age ≤18 years
• ASA ≥ IV.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of cognitive dysfunction after thoracic surgery	change of MMSE score from the day before surgery (baseline) at 1 day after surgery	A decrease in Mini-Mental State Examination (MMSE) score \> 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD)

Secondary Outcome Measures

Name	Time	Method
role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.	change of cerebral saturation from baseline(before surgery) at intraoperative measure	monitoring values of cerebral saturation during intraoperative period:Cerebral desaturation was defined as a reduction of rSO2 during OLV of more than 20% from the baseline value
role of hypertension as risk factors for POCD in patients undergoing lung resection.	change of blood pressure from baseline(before surgery) at intraoperative measure	monitoring values of blood pressure during intraoperative period

Trial Locations

Locations (1)

azienda ospedaliero universitaria Sant'Andrea; 🇮🇹 Roma, Italy