NCT03430778

Brief Summary

The primary purpose of this study is to investigate the effect of pneumoperitoneum 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
70

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable gastric-cancer

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

February 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2019

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

February 1, 2018

Last Update Submit

May 17, 2019

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • difference between SpHb value and SaHb value (SpHb - SaHb)

    SpHb value is measured by co-oxymetry, and SaHb value is measured by blood sampling.

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

Study Arms (2)

High CO2 group

EXPERIMENTAL

end tidal CO2 : 40-45 mmHg

Other: High end-tidal CO2

Low CO2 group

PLACEBO COMPARATOR

end tidal CO2 : 30-35 mmHg

Other: Low CO2 group

Interventions

High end-tidal CO2OTHER

maintaining of end-tidal CO2 with the range of 40-45 mmHg

High CO2 group
Low CO2 groupOTHER

maintaining of end-tidal CO2 with the range of 30-35 mmHg

Low CO2 group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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, Seoum, 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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 13, 2018

Study Start

January 1, 2019

Primary Completion

May 13, 2019

Study Completion

May 13, 2019

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

KR(1)