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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805880
Other study ID # SATURIMETRIA
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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