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Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT03805880
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Silvia Fiorelli, University of Roma La Sapienza

Study Description
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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.

Condition or disease Intervention/treatment
Thoracic Surgery Cognitive Dysfunction Diagnostic Test: cerebral desaturation monitoring and cognitive examination

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : July 31, 2018
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. incidence of cognitive dysfunction after thoracic surgery [ Time Frame: 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 :
  1. role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection. [ Time Frame: 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

  2. role of hypertension as risk factors for POCD in patients undergoing lung resection. [ Time Frame: change of blood pressure from baseline(before surgery) at intraoperative measure ]
    monitoring values of blood pressure during intraoperative period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients scheduled for elective lobectomy or wedge resection via thoracotomy requiring an OLV duration ≥ 45 min
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805880


Locations
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Italy
azienda ospedaliero universitaria Sant'Andrea
Roma, Italy
Sponsors and Collaborators
University of Roma La Sapienza
More Information
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Responsible Party: Silvia Fiorelli, principal investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03805880    
Other Study ID Numbers: SATURIMETRIA
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders