NCT04057586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

February 14, 2023

Status Verified

June 1, 2019

Enrollment Period

3.2 years

First QC Date

August 14, 2019

Last Update Submit

February 9, 2023

Conditions

Cognition

Keywords

postoperative cognitionnonintubated thoracic surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Intraoperative cerebral oxygenation

    throughout surgery; approximately 2.5 hours

  • Comprehensive complication index

    The hospital stayl approximately 3 days

Study Arms (2)

Nonintubated

EXPERIMENTAL

Nonintubated thoracoscopic surgery

Procedure: Nonintubated

Intubated

ACTIVE COMPARATOR

Intubated thoracoscopic surgery

Procedure: Intubated

Interventions

NonintubatedPROCEDURE

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

Nonintubated
IntubatedPROCEDURE

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

Intubated

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients receive elective thoracoscopic surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 15, 2019

Study Start

August 14, 2019

Primary Completion

November 12, 2022

Study Completion

November 12, 2022

Last Updated

February 14, 2023

Record last verified: 2019-06

Locations

TW(1)