Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

NCT03805880 | Completed

• 1 other identifier: SATURIMETRIA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection.

  change of cerebral saturation from baseline(before surgery) at intraoperative measure

• role of hypertension as risk factors for POCD in patients undergoing lung resection.

  change of blood pressure from baseline(before surgery) at intraoperative measure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patients scheduled for elective lobectomy or wedge resection via thoracotomy
• one lung ventilation (OLV duration) ≥ 45 min

You may not qualify if:

• previous cerebral disease,
• dementia,
• severe cognitive dysfunction
• emergency surgery
• pregnancy
• patient refusal to give consent
• inability to give consent
• age ≤18 years
• ASA ≥ IV.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

azienda ospedaliero universitaria Sant'Andrea

Roma, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 16, 2019
• Study Start: January 1, 2018
• Primary Completion: March 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)