Skip to main content
Clinical Trials/NCT04057586
NCT04057586CompletedNot Applicable

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

National Taiwan University Hospital1 site in 1 country110 target enrollmentStarted: August 14, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
1
Primary Endpoint
Postoperative cognitive recovery

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients receive elective thoracoscopic surgery

Exclusion Criteria

  • •preexisting cerebral dysfunction such as cerebral vascular incidence, Alzheimer's Disease. Parkinsonism.
  • •Cardiopulmonary dysfunction such as heart failure > New York Heart Association score III; chronic obstructive pulmonary disease with a forced expiratory volume in one second/forced vital capacity < 70 % and FEV1 < 50% predicted.

Arms & Interventions

Nonintubated

Experimental

Nonintubated thoracoscopic surgery

Intervention: Nonintubated (Procedure)

Intubated

Active Comparator

Intubated thoracoscopic surgery

Intervention: Intubated (Procedure)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials