Cognitive Dysfunction Clinical Trial
Official title:
Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study
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 |
Verified date | January 2019 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | azienda ospedaliero universitaria Sant'Andrea | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
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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