Skip to main content
OpenTrials
Completed

NCT Number: NCT03805880

Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracic Surgery Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

azienda ospedaliero universitaria Sant'Andrea

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cerebral desaturation monitoring and cognitive examination

Diagnostic Test

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.