NCT03957460

Brief Summary

The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 20, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

May 17, 2019

Last Update Submit

May 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb)

    SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling.

    from the start of anesthesia to the end of anesthesia, an average 2 hours

Study Arms (1)

continuous and noninvasive hemoglobin monitoring

Group receive the continuous and noninvasive hemoglobin monitoring during laparoscopic gastrectomy.

Other: SpHb monitoring

Interventions

Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).

continuous and noninvasive hemoglobin monitoring

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring during surgery.

You may qualify if:

  • laparoscopic gastrectomy under general anesthesia

You may not qualify if:

  • atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

November 20, 2017

Primary Completion

December 29, 2017

Study Completion

December 29, 2017

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations