Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

Not Applicable

Completed

• Conditions: Cognition
• Interventions: Procedure: Intubated; Procedure: Nonintubated

• Registration Number: NCT04057586
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Status Verified: 2019-06
• Study Start: 2019-08-14
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Primary Completion: 2022-11-12
• Study Completion: 2022-11-12
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubated	Intubated	Intubated thoracoscopic surgery
Nonintubated	Nonintubated	Nonintubated thoracoscopic surgery

Primary Outcome Measures

Name	Time	Method
Postoperative cognitive recovery	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 Outcome Measures

Name	Time	Method
Intraoperative cerebral oxygenation	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	The hospital stayl approximately 3 days	The comprehensive complication index was calculated in each patient during the hospital stay.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan