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Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04057586
Enrollment
110
Registered
2019-08-15
Start date
2019-08-14
Completion date
2022-11-12
Last updated
2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition

Keywords

postoperative cognition, nonintubated thoracic surgery

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.

Interventions

PROCEDURENonintubated

During surgery, patient is deeply sedated and respiration is maintained by spontaneous breath under the nasal high flow oxygen support.

PROCEDUREIntubated

During surgery, patient received standard general anesthesia and respiration is maintained by using mechanical ventilation.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative cognitive recovery6 monthsPostoperative 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

MeasureTime frameDescription
Intraoperative cerebral oxygenationthroughout surgery; approximately 2.5 hoursIntraoperative cerebral oxygenation changes during one-lung ventilation will be noninvasively monitored by using near infrared spectroscopy.
Comprehensive complication indexThe hospital stayl approximately 3 daysThe comprehensive complication index was calculated in each patient during the hospital stay.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026