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Clinical Trials/NCT04057586
NCT04057586
Completed
N/A

Postoperative Cognitive Dysfunction After Intubated and Non-intubated Thoracic Surgery: a Randomized Controlled Trial

National Taiwan University Hospital1 site in 1 country110 target enrollmentAugust 14, 2019
ConditionsCognition

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognition
Sponsor
National Taiwan University Hospital
Enrollment
110
Locations
1
Primary Endpoint
Postoperative cognitive recovery
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In this randomized controlled trial, we aim to investigate whether the avoidance of mechanical ventilation by application of nonintubated thoracoscopic surgery improves intraoperative cerebral oxygenation and postoperative cognition recovery for patients undergoing thoracic surgery.

Detailed Description

Postoperative neurocognitive impairment is not uncommon for patients undergoing thoracic surgery. Based on the literature, this is associated with reduced cerebral oxygenation during one-lung ventilation which may be because of reduced cardiac output, impeded cerebral venous return due to mechanical ventilation. In our hospital, nonintubated thoracoscopic surgery is commonly conducted and achieves noninferior outcomes than intubated thoracoscopic surgery. Particularly, the application of nasal high flow oxygen may maintain intraoperative oxygenation despite the absence of controlled ventilation. Therefore, the nonintubated technique may be beneficial to maintain an improved intraoperative cerebral oxygenation and hopefully improves postoperative cognition recovery. In this randomized controlled study, we aim to investigate the differences in intraoperative cerebral oxygenation and postoperative cognitive recovery bewteen nonintubated and intubated thoracoscopic surgery. Patient will be randomly assigned to receive nonintubated or intubated thoracoscopic surgery. During surgery, bifrontal cerebral oxygenation will be monitored. Cognitive test will be arranged before and after surgery.

Registry
clinicaltrials.gov
Start Date
August 14, 2019
End Date
November 12, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Postoperative cognitive recovery

Time Frame: 6 months

Postoperative cognitive recovery assessed by using the Taiwanese quick mild cogntive impairment (Qmci-TW) test (score 0-100) at the baseline (the day before surgery), 24 hour and 6 months after surgery

Secondary Outcomes

  • Intraoperative cerebral oxygenation(throughout surgery; approximately 2.5 hours)
  • Comprehensive complication index(The hospital stayl approximately 3 days)

Study Sites (1)

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