Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057586
• Other study ID #: 201904071RINC
• Status: Completed
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: November 12, 2022

Study information

• Verified date: June 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 12, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Comprehensive complication index	The comprehensive complication index was calculated in each patient during the hospital stay.	The hospital stayl approximately 3 days