Monitoring Hypertensive Patients's Cerebral Oxygen Saturation
MHPCOS
Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery
2 other identifiers
observational
41
1 country
1
Brief Summary
The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2014
Shorter than P25 for all trials
1 active site
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
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 11, 2014
November 1, 2014
6 months
May 22, 2014
November 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
decreases in cerebral oxygen saturation (rSO2) during the surgery
every 5 minutes throughout the surgery
Secondary Outcomes (1)
Change from baseline in Mini-Mental State Exam (MMSE) perioperative period
Baseline, 4 day after surgery
Study Arms (1)
hypertension disease
patients have hypertension disease, whether well-controlled or uncontrolled, more than 3 year
Eligibility Criteria
patients scheduled for major abdominal surgery such as gastrectomy, colon resection ,liver resection and duodenocephalo-pancreasectomy
You may qualify if:
- patients have hypertension more than 3 year,whether well-controlled or uncontrolled,
- scheduled for major abdominal surgery for at least 2 h
- under general anesthesia
- American Society of Anesthesiologists（ASA）physical status : II \~ III
- Age \> 30
You may not qualify if:
- pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;
- ASA physical status \>IV
- hepatic failure
- renal failure
- preoperative Mini-Mental State Examination (MMSE) score less than 24
- a history of cardiovascular surgery or craniotomy
- cardiac failure
- respiratory failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Related Publications (1)
Li H, Fu Q, Wu Z, Sun J, Manyande A, Yang H, Wang P. Cerebral oxygen desaturation occurs frequently in patients with hypertension undergoing major abdominal surgery. J Clin Monit Comput. 2018 Apr;32(2):285-293. doi: 10.1007/s10877-017-0024-0. Epub 2017 May 9.
PMID: 28488169DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peng Wang, MD PHD
Vice Director
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesiology, Tongji Hospital of Tongji Medical College
Study Record Dates
First Submitted
May 22, 2014
First Posted
May 26, 2014
Study Start
May 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 11, 2014
Record last verified: 2014-11