Cognitive Recovery Between Intubated and Non-intubated Thoracic Surgery

NCT ID: NCT04057586

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2022-11-12

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.

Conditions

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Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nonintubated

Nonintubated thoracoscopic surgery

Group Type EXPERIMENTAL

Nonintubated

Intervention Type PROCEDURE

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

Intubated

Intubated thoracoscopic surgery

Group Type ACTIVE_COMPARATOR

Intubated

Intervention Type PROCEDURE

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

Interventions

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Nonintubated

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

Intervention Type PROCEDURE

Intubated

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Yu Wu

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201904071RINC

Identifier Type: -

Identifier Source: org_study_id

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