Clinical trial NCT05957497: Drone Biological Samples Transport vs Walking (DBT - Drone Biology Transport)
Official title: Drone Biological Samples Transport Evaluation Compared to Walking in CHU CAEN NORMANDIE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Sample transport
Drone
Pre-Analytical Phase
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

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.

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

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, over 18 years old

Exclusion Criteria:

* Unhealthy volunteers previously known
* pregnant or breastfeeding woman

Primary outcomes:
measure: Impact on Sodium test
timeFrame: 1 day
measure: Impact on Potassium test
timeFrame: 1 day
measure: Impact on Chlorure test
timeFrame: 1 day
measure: Impact on Bicarbonate test
timeFrame: 1 day
measure: Impact on Protein test
timeFrame: 1 day
measure: Impact on Calcium test
timeFrame: 1 day
measure: Impact on Creatinin test
timeFrame: 1 day
measure: Impact on Urea test
timeFrame: 1 day
measure: Impact on Albumin test
timeFrame: 1 day
measure: Impact on Bilirubin test
timeFrame: 1 day
measure: Impact on liver transaminase (ALT) test
timeFrame: 1 day
measure: Impact on liver transaminase (AST) test
timeFrame: 1 day
measure: Impact on alkalin phosphatase test
timeFrame: 1 day
measure: Impact on GGT test
timeFrame: 1 day
measure: Impact on LDH test
timeFrame: 1 day
measure: Impact on C-reactive Protein test
timeFrame: 1 day
measure: Impact on red blood cells count
timeFrame: 1 day
measure: Impact on hemoglobin test
timeFrame: 1 day
measure: Impact on white blood cells count
timeFrame: 1 day
measure: Impact on neutrophil cells count
timeFrame: 1 day
measure: Impact on lymphocytes cells count
timeFrame: 1 day
measure: Impact on platelets count
timeFrame: 1 day
measure: Impact on sedimentation rate test
timeFrame: 1 day
measure: Impact on PT test
timeFrame: 1 day
measure: Impact on a-PTT test
timeFrame: 1 day
measure: Impact on Fibrinogen test
timeFrame: 1 day
measure: Impact on D-Dimer test
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of the users security
timeFrame: 1 day
measure: Evaluation of the users safety
timeFrame: 1 day
measure: Temperature
timeFrame: 1 day
Other outcomes:
Locations:
city: Caen
country: France
facility: Chu Caen Normandie
Study officials:
affiliation: CHU CAEN NORMANDIE
name: Benjamin GILLET, MD
role: STUDY_CHAIR
References: