NCT03397745

Brief Summary

The investigators try to conduct a study to assess the impact of changing patients' lateral decubitus position on BIS readings during esophageal cancer operation. Also, the investigators evaluate the effects of one-lung ventilation and total lung ventilation on BIS value with inhalation agent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2018

Completed
Last Updated

September 4, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

January 2, 2018

Last Update Submit

August 30, 2018

Conditions

Esophageal Cancer

Keywords

bispectral indexlateral decubitus positionone lung ventilation

Outcome Measures

Primary Outcomes (1)

  • Change in Bispectral index score

    The difference of both side BIS value on lateral decubitus position

    after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins

Secondary Outcomes (3)

  • the asymmetry of BIS

    after supine position 5 mins, 10 mins, 20 mins, 30 mins

  • oxygenation and BIS

    intraoperative

  • The changes of BIS

    intraoperative

Study Arms (1)

BIS group

OTHER

Patients who received the esophageal surgery

Device: BIS

Interventions

BISDEVICE

All patients applied BIS on both side (Left and Right)

BIS group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the patients who are planned the esophageal cancer operation

You may not qualify if:

  • patient who has dermatitis
  • patient who refuse to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 12, 2018

Study Start

January 15, 2018

Primary Completion

August 3, 2018

Study Completion

August 3, 2018

Last Updated

September 4, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)