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Normoxic Challenges Utility to Evaluate Blood Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03194581
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : February 12, 2019
Information provided by (Responsible Party):
Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa

Brief Summary:
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.

Condition or disease Intervention/treatment
Hemorrhage Device: Cerebral oxygenation

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Normoxic Challenges Utility to Evaluate Blood Loss Through Cerebral Oxygenation
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Intervention Details:
  • Device: Cerebral oxygenation
    Evaluate cerebral oxygenation using normoxic challenges

Primary Outcome Measures :
  1. Change in cerebral regional oxygen saturation [ Time Frame: Before and 3 minutes after normoxic challenges ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients submitted to surgery with high risk of blood loss

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03194581

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Contact: Mariana Cunha 00351255147559

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Centro Hospitalar Tâmega e Sousa Recruiting
Penafiel, Porto, Portugal
Contact: Mariana M Cunha         
Sponsors and Collaborators
Centro Hospitalar do Tâmega e Sousa

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Responsible Party: Mariana Marques da Cunha, MD, Centro Hospitalar do Tâmega e Sousa Identifier: NCT03194581    
Other Study ID Numbers: HEMOX
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes