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

Sponsor
Intelligence Anesthesia (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04484233
Collaborator
(none)
1,000
4

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Average global score obtained for the two groups. [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. [Up to 24 weeks]

    The mean number of correct answers (out of possible 10);

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Anesthesiologist: anesthesiologists, resident/fellow physician anesthesiologists.
Exclusion Criteria:
  • Unfinished questionnaire.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Intelligence Anesthesia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Intelligence Anesthesia
ClinicalTrials.gov Identifier:
NCT04484233
Other Study ID Numbers:
  • IRB 00010254-2020-131
First Posted:
Jul 23, 2020
Last Update Posted:
Jul 23, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Intelligence Anesthesia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2020