Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

January 12, 2019 updated by: Silvia Fiorelli, University of Roma La Sapienza

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Azienda Ospedaliero Universitaria Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients scheduled for elective lobectomy or wedge resection via thoracotomy requiring an OLV duration ≥ 45 min

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change of MMSE score from the day before surgery (baseline) at 1 day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change of cerebral saturation from baseline(before surgery) at intraoperative measure
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
change of blood pressure from baseline(before surgery) at intraoperative measure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 12, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SATURIMETRIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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