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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU Caen Normandie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

• Healthy volunteers, over 18 years old

Exclusion Criteria:

• Unhealthy volunteers previously known
• pregnant or breastfeeding woman

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on Sodium test	Evaluation difference between results of Sodium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Potassium test	Evaluation difference between results of Potassium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Chlorure test	Evaluation difference between results of Chlorure (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Bicarbonate test	Evaluation difference between results of Bicarbonate (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Protein test	Evaluation difference between results of Protein (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Calcium test	Evaluation difference between results of Calcium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Creatinin test	Evaluation difference between results of Creatinin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Urea test	Evaluation difference between results of Urea (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Albumin test	Evaluation difference between results of Albumin (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Bilirubin test	Evaluation difference between results of Bilirubin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on liver transaminase (ALT) test	Evaluation difference between results of liver transaminase (ALT, U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on liver transaminase (AST) test	Evaluation difference between results of liver transaminase (AST, U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on alkalin phosphatase test	Evaluation difference between results of alkalin phosphatase (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on GGT test	Evaluation difference between results of GGT (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on LDH test	Evaluation difference between results of LDH (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on C-reactive Protein test	Evaluation difference between results of C-reactive Protein (mg/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on red blood cells count	Evaluation difference between results of red blood cells (T/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on hemoglobin test	Evaluation difference between results of hemoglobin (g/dL) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on white blood cells count	Evaluation difference between results of white blood cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on neutrophil cells count	Evaluation difference between results of neutrophil cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on lymphocytes cells count	Evaluation difference between results of lymphocytes cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on platelets count	Evaluation difference between results of platelets (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on sedimentation rate test	Evaluation difference between results of sedimentation rate (mm) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on PT test	Evaluation difference between results of PT (sec and %) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on a-PTT test	Evaluation difference between results of a-PTT (sec) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on Fibrinogen test	Evaluation difference between results of Fibrinogen (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Impact on D-Dimer test	Evaluation difference between results of D-Dimer (ng/mL) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the users security	Report accident of drone or users injuries	1 day
Evaluation of the users safety	Report numbers of samples broken (contamination risk) after drone transport	1 day
Temperature	Temperature measurement during the transport. Evaluation of the ambient temperature respect during the transport in the two conditions.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Chair: Benjamin GILLET, MD, CHU Caen Normandie

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): August 27, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Drone; Sample transport; Pre-Analytical Phase
• Other Study ID Numbers: 22-0238; 2022-A02548-35 (Registry Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No