Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognition

Intervention / Treatment
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* Procedure: Nonintubated
* Procedure: Intubated


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult patients receive elective thoracoscopic surgery Exclusion criteria: pregnancy 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonintubated<br>Nonintubated thoracoscopic surgery | Procedure: Nonintubated<br>* During surgery, patient is deeply sedated and respiration is maintained by spontaneous breath under the nasal high flow oxygen support.<br>|
| Active Comparator: Intubated<br>Intubated thoracoscopic surgery | Procedure: Intubated<br>* During surgery, patient received standard general anesthesia and respiration is maintained by using mechanical ventilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative cognitive recovery | 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 | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative cognition, nonintubated thoracic surgery