NCT02356133

Brief Summary

record,describe and discuss the relationship among rSO2, MAP,CAM value, vital organ disfunction and the outcome of patients after operation by Near-Infrared Spectroscopy in Endovascular Neurosurgery

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

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 24, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

January 24, 2015

Last Update Submit

August 4, 2018

Conditions

Near-Infrared Spectroscopy in Endovascular Neurosurgery

Keywords

Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (3)

  • there is relationship between rSO2 and MAP during neurosurgery

    2 month

  • there is relatinship between rSO2 and CAM values

    2 month

  • vital organ disfunction related to rSO2 and bad outcome of the patients

    3 month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Scheduled to undergoing Endovascular Neurosurgery

You may qualify if:

  • American Society of Anesthesiology (ASA) class I\~Ⅲ, ranging in age from 18 to 80 years

You may not qualify if:

  • ASA\>Ⅳ
  • Non-cooperators
  • Morbid obesity (BMI\>35kg/m2)
  • Preoperative hyperresponsiveness airway and gastro-esophageal reflux
  • The existence of the state or a diagnosis of dementia, delirium, depression, cognitive dysfunction before surgery were also excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang X, Feng K, Liu H, Liu Y, Ye M, Zhao G, Wang T. Regional cerebral oxygen saturation and postoperative delirium in endovascular surgery: a prospective cohort study. Trials. 2019 Aug 14;20(1):504. doi: 10.1186/s13063-019-3586-y.

    PMID: 31412906DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2015

First Posted

February 5, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

August 7, 2018

Record last verified: 2018-08