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Completed

NCT Number: NCT05957497

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Caen Normandie

Caen, 14000, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers, over 18 years old

Exclusion criteria

  • Unhealthy volunteers previously known
  • pregnant or breastfeeding woman

Treatment and study plan

Biological samples transport and analysis

Biological

Biological samples transport and analysis

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Drone Biological Samples Transport Evaluation Compared to Walking in CHU CAEN NORMANDIE

Acronym: DBT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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