- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03194581
Normoxic Challenges Utility to Evaluate Blood Loss
March 19, 2022 updated by: Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa
Normoxic Challenges Utility to Evaluate Blood Loss Through Cerebral Oxygenation
This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.
Study Overview
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Porto
-
Penafiel, Porto, Portugal
- Centro Hospitalar Tâmega e Sousa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients submitted to surgery with high risk of blood loss
Description
Inclusion Criteria:
- Elective surgery
- High risk of intraoperative blood loss
- General anaesthesia
Exclusion Criteria:
- Respiratory insufficiency
- Ischemic heart disease
- Stroke
- ASA classification > 3
- Laparoscopic surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in cerebral regional oxygen saturation
Time Frame: Before and 3 minutes after normoxic challenges
|
Before and 3 minutes after normoxic challenges
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
June 12, 2017
First Submitted That Met QC Criteria
June 19, 2017
First Posted (Actual)
June 21, 2017
Study Record Updates
Last Update Posted (Actual)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 19, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEMOX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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