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Drone Biological Samples Transport vs Walking (DBT - Drone Biology Transport) (DBT)

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ClinicalTrials.gov Identifier: NCT05957497
Recruitment Status : Completed
First Posted : July 24, 2023
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:

The transport of biological samples is a key step in the pre-analysis process in health facilities and must meet quality requirements (NF:EN:ISO 151989) to ensure that samples are transported in are transported in good conditions.

Still in the experimental stage, drone-based air transport is participating in the aeronautical revolution of the development of unmanned aircraft on board in all areas of society, including health.

This first project, led by the Biology Centre and the INNOVABIO Biological Resources Centre of the CHU de CAEN in collaboration with the company Delivrone, will allow to evaluate the feasibility in real condition of the mode of transport by drone versus transport of reference on the quality of a varied panel of medical biology examinations (biochemistry, hematology and haemostasis), on the safety of people (potentially infectious samples), on the control of the delivery time, on the control of the transport temperature (15-25°C ). The samples will be taken on 30 healthy volunteers with a total panel of 23 blood tests performed.


Condition or disease Intervention/treatment
Healthy Biological: Biological samples transport and analysis

Detailed Description:

Panel of blood tests performed on healthy volunteers samples include :

  • Na, K, Cl, HC03-
  • total protein
  • Ca
  • Creatinine, urea
  • Albumine
  • Bilirubin
  • Liver transaminases (ALT, AST)
  • Alkaline phosphatase
  • GGT
  • LDH
  • C-reactive protein
  • Complete Blood Count
  • Sedimentation rate
  • PT
  • aPTT
  • Fibrinogen
  • D-Dimer
Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drone Biological Samples Transport Evaluation Compared to Walking in CHU CAEN NORMANDIE
Actual Study Start Date : April 27, 2023
Actual Primary Completion Date : August 27, 2023
Actual Study Completion Date : August 30, 2023
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pedestrian transport
Modality of transport currently used
 Biological: Biological samples transport and analysis
Biological samples transport and analysis
Drone transport
Innovative modality of transport
 Biological: Biological samples transport and analysis
Biological samples transport and analysis


Outcome Measures
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Primary Outcome Measures :
  1. Impact on Sodium test [ Time Frame: 1 day ]
    Evaluation difference between results of Sodium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  2. Impact on Potassium test [ Time Frame: 1 day ]
    Evaluation difference between results of Potassium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  3. Impact on Chlorure test [ Time Frame: 1 day ]
    Evaluation difference between results of Chlorure (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  4. Impact on Bicarbonate test [ Time Frame: 1 day ]
    Evaluation difference between results of Bicarbonate (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  5. Impact on Protein test [ Time Frame: 1 day ]
    Evaluation difference between results of Protein (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  6. Impact on Calcium test [ Time Frame: 1 day ]
    Evaluation difference between results of Calcium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  7. Impact on Creatinin test [ Time Frame: 1 day ]
    Evaluation difference between results of Creatinin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  8. Impact on Urea test [ Time Frame: 1 day ]
    Evaluation difference between results of Urea (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  9. Impact on Albumin test [ Time Frame: 1 day ]
    Evaluation difference between results of Albumin (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  10. Impact on Bilirubin test [ Time Frame: 1 day ]
    Evaluation difference between results of Bilirubin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  11. Impact on liver transaminase (ALT) test [ Time Frame: 1 day ]
    Evaluation difference between results of liver transaminase (ALT, U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  12. Impact on liver transaminase (AST) test [ Time Frame: 1 day ]
    Evaluation difference between results of liver transaminase (AST, U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  13. Impact on alkalin phosphatase test [ Time Frame: 1 day ]
    Evaluation difference between results of alkalin phosphatase (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  14. Impact on GGT test [ Time Frame: 1 day ]
    Evaluation difference between results of GGT (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  15. Impact on LDH test [ Time Frame: 1 day ]
    Evaluation difference between results of LDH (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  16. Impact on C-reactive Protein test [ Time Frame: 1 day ]
    Evaluation difference between results of C-reactive Protein (mg/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  17. Impact on red blood cells count [ Time Frame: 1 day ]
    Evaluation difference between results of red blood cells (T/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  18. Impact on hemoglobin test [ Time Frame: 1 day ]
    Evaluation difference between results of hemoglobin (g/dL) after drone transport (30 samples) versus pedestrian transport (30 samples).

  19. Impact on white blood cells count [ Time Frame: 1 day ]
    Evaluation difference between results of white blood cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  20. Impact on neutrophil cells count [ Time Frame: 1 day ]
    Evaluation difference between results of neutrophil cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  21. Impact on lymphocytes cells count [ Time Frame: 1 day ]
    Evaluation difference between results of lymphocytes cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  22. Impact on platelets count [ Time Frame: 1 day ]
    Evaluation difference between results of platelets (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  23. Impact on sedimentation rate test [ Time Frame: 1 day ]
    Evaluation difference between results of sedimentation rate (mm) after drone transport (30 samples) versus pedestrian transport (30 samples).

  24. Impact on PT test [ Time Frame: 1 day ]
    Evaluation difference between results of PT (sec and %) after drone transport (30 samples) versus pedestrian transport (30 samples).

  25. Impact on a-PTT test [ Time Frame: 1 day ]
    Evaluation difference between results of a-PTT (sec) after drone transport (30 samples) versus pedestrian transport (30 samples).

  26. Impact on Fibrinogen test [ Time Frame: 1 day ]
    Evaluation difference between results of Fibrinogen (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).

  27. Impact on D-Dimer test [ Time Frame: 1 day ]
    Evaluation difference between results of D-Dimer (ng/mL) after drone transport (30 samples) versus pedestrian transport (30 samples).


Secondary Outcome Measures :
  1. Evaluation of the users security [ Time Frame: 1 day ]
    Report accident of drone or users injuries

  2. Evaluation of the users safety [ Time Frame: 1 day ]
    Report numbers of samples broken (contamination risk) after drone transport

  3. Temperature [ Time Frame: 1 day ]
    Temperature measurement during the transport. Evaluation of the ambient temperature respect during the transport in the two conditions.


Biospecimen Retention:   Samples Without DNA
blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers
Criteria

Inclusion Criteria:

  • Healthy volunteers, over 18 years old

Exclusion Criteria:

  • Unhealthy volunteers previously known
  • pregnant or breastfeeding woman
Contacts and Locations
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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): NCT05957497


Locations
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France
Chu Caen Normandie
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Study Chair: Benjamin GILLET, MD CHU CAEN NORMANDIE
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT05957497    
Other Study ID Numbers: 22-0238
2022-A02548-35 ( Registry Identifier: ID RCB )
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Sample transport
Drone
Pre-Analytical Phase