Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

Cognitive Dysfunction Clinical Trial

Official title:

Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805880
• Other study ID #: SATURIMETRIA
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Thoracic Surgery

Intervention

Diagnostic Test:
• cerebral desaturation monitoring and cognitive examination
Before general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery.

Locations

Country	Name	City	State
Italy	azienda ospedaliero universitaria Sant'Andrea	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of cognitive dysfunction after thoracic surgery	A decrease in Mini-Mental State Examination (MMSE) score > 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD)	change of MMSE score from the day before surgery (baseline) at 1 day after surgery
Secondary	role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.	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	change of cerebral saturation from baseline(before surgery) at intraoperative measure
Secondary	role of hypertension as risk factors for POCD in patients undergoing lung resection.	monitoring values of blood pressure during intraoperative period	change of blood pressure from baseline(before surgery) at intraoperative measure