We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 55 for:    intelligence anesthesia
Previous Study | Return to List | Next Study

Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care (iAnemia)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484233
Recruitment Status : Unknown
Verified July 2020 by Intelligence Anesthesia.
Recruitment status was:  Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Intelligence Anesthesia

Brief Summary:

Anemia need to be diagnosed and treated, following several guidelines. However, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.

In order to improve practices and regarding the complexity of the guidelines, the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia.


Condition or disease Intervention/treatment
Decision Support Systems Anemia Device: iAnemia Decision Support System

Detailed Description:

The World Health Organization defines anemia as a hemoglobin level of less than 13 g/dL in adult men and less than 12 g/dL in women.

The cause of these anemias is most often deficient with 17% iron deficiency. This deficiency is related to age, inflammatory diseases, blood loss, and absorption disorders mainly. Anemia must be diagnosed preoperatively and treated.

To reduce transfusion in the perioperative period there are various possibilities: increase of the preoperative erythrocyte mass, reduction of losses, use of the blood that has been applied.

The impact of these preoperative strategies can be considerable. In their work, Beattie and al demonstrates that transfusion is associated with an increase in mortality at 90 days, proportional to the volume transfused, with certainly a higher risk in fragile subjects. More recently, an American registry of more than 220,000 patients showed that 30% had preoperative anemia. This anemia not only significantly increased mortality, but all causes of comorbidity were aggravated in an anemic patient.

However, the complexity of these recommendations leads to low compliance and to unnecessary and harmful per- and postoperative blood transfusion.

In order to improve practices and regarding the complexity of the guidelines, the latest European Consensus Conference recommends the use of decision support systems for the management of preoperative anemia.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of a Clinical Decision Support System for Anemia Management in Pre-operative Care: Feasibility & Validation Study
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
Control Group
Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management.
Clinical Decision Support Group
Anesthesiologists would have to respond to an online questionnaire about 10 hypotheticals clinical situations regarding patient blood management helped by dedicated clinical decision support systems for patient blood management (iAnemia, Intelligence Anesthesia).
Device: iAnemia Decision Support System
iAnemia permits to display the appropriate guideline using several inputs about a patient: age, type and delay of the surgery, gender, hemoglobin level, and iron deficiency status.




Primary Outcome Measures :
  1. Average global score obtained for the two groups. [ Time Frame: Up to 24 weeks ]
    The mean number of correct answers (out of possible 10);


Secondary Outcome Measures :
  1. Average subcategories score obtained for the two groups. [ Time Frame: Up to 24 weeks ]
    The mean number of correct answers (out of possible 10);



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Anesthesiologist:

  • Less than one year experience in anesthesia
  • 2 to 5 years of experience
  • 5 to 10 years of experience
  • 10 to 20 years of experience
  • More than 20 years of experience
Criteria

Inclusion Criteria:

  • Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.

Exclusion Criteria:

  • Unfinished questionnaire.

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 ClinicalTrials.gov identifier (NCT number): NCT04484233


Contacts
Layout table for location contacts
Contact: Yassine Moussali, MD +33620858135 y.moussali@intelligenceanesthesia.com

Sponsors and Collaborators
Intelligence Anesthesia
Publications:
Layout table for additonal information
Responsible Party: Intelligence Anesthesia
ClinicalTrials.gov Identifier: NCT04484233    
Other Study ID Numbers: IRB 00010254-2020-131
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Intelligence Anesthesia:
Clinical Decision Support Systems
Patient Blood Management
Preoperative Anemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Hematologic Diseases