NCT02687334

Brief Summary

The aim of this study was to investigate the changes of cerebral oxygen saturation (rSO2) during anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

February 17, 2016

Last Update Submit

May 8, 2016

Conditions

Cerebral Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

  • changes of cerebral oxygen saturation

    the relationship between the cerebral oxygen saturation (rSO2) and pressure of carbon dioxide (PaCO2) and oxygen (PaO2) in arterial blood

    Baseline and 30 minutes

Study Arms (1)

Standard general anesthesia induction

Patients scheduled for elective surgery at the First Hospital of China Medical University will be recruited for the study beginning in February 2016.We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia

Drug: 100% Oxygen

Interventions

100% OxygenDRUG

We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen

Standard general anesthesia induction

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients scheduled for elective radical operations for mastocarcinomaat in the First Hospital of China Medical University will be recruited for the study

You may qualify if:

  • Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II, and undergoing a radical operation for mastocarcinoma.

You may not qualify if:

  • Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a history of hypertension or diabetes mellitus, or were allergic to anesthesia drugs used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Wen-fei Tan, M.D.,PhD.

    the First Hoapital of China Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate proffesor

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 22, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)