Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

Overview

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.

Full Title of Study: “Postoperative Cognitive Dysfunction After Intubated and Non-intubated Thoracic Surgery: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 12, 2022

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.

Interventions

  • Procedure: Nonintubated
    • During surgery, patient is deeply sedated and respiration is maintained by spontaneous breath under the nasal high flow oxygen support.
  • Procedure: Intubated
    • During surgery, patient received standard general anesthesia and respiration is maintained by using mechanical ventilation.

Arms, Groups and Cohorts

  • Experimental: Nonintubated
    • Nonintubated thoracoscopic surgery
  • Active Comparator: Intubated
    • Intubated thoracoscopic surgery

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Intraoperative cerebral oxygenation
    • Time Frame: throughout surgery; approximately 2.5 hours
    • Intraoperative cerebral oxygenation changes during one-lung ventilation will be noninvasively monitored by using near infrared spectroscopy.
  • Comprehensive complication index
    • Time Frame: The hospital stayl approximately 3 days
    • The comprehensive complication index was calculated in each patient during the hospital stay.

Participating in This Clinical Trial

Inclusion Criteria

Adult patients receive elective thoracoscopic surgery Exclusion criteria:

1. pregnancy 2. preexisting cerebral dysfunction such as cerebral vascular incidence, Alzheimer's Disease. Parkinsonism. 3. 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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chun-Yu Wu, Principal Investigator, National Taiwan University Hospital

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