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

Healthy Clinical Trial

— DBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957497
• Other study ID #: 22-0238
• Secondary ID: 2022-A02548-35
• Status: Completed
• Start date: April 27, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2023
• Est. primary completion date: August 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers, over 18 years old

Exclusion Criteria:

• Unhealthy volunteers previously known

• pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Biological samples transport and analysis
Biological samples transport and analysis

Locations

Country	Name	City	State
France	Chu Caen Normandie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on Sodium test	Evaluation difference between results of Sodium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Potassium test	Evaluation difference between results of Potassium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Chlorure test	Evaluation difference between results of Chlorure (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Bicarbonate test	Evaluation difference between results of Bicarbonate (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Protein test	Evaluation difference between results of Protein (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Calcium test	Evaluation difference between results of Calcium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Creatinin test	Evaluation difference between results of Creatinin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Urea test	Evaluation difference between results of Urea (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Albumin test	Evaluation difference between results of Albumin (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on Bilirubin test	Evaluation difference between results of Bilirubin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	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
Primary	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
Primary	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
Primary	Impact on GGT test	Evaluation difference between results of GGT (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	Impact on LDH test	Evaluation difference between results of LDH (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	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
Primary	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
Primary	Impact on hemoglobin test	Evaluation difference between results of hemoglobin (g/dL) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	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
Primary	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
Primary	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
Primary	Impact on platelets count	Evaluation difference between results of platelets (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	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
Primary	Impact on PT test	Evaluation difference between results of PT (sec and %) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	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
Primary	Impact on Fibrinogen test	Evaluation difference between results of Fibrinogen (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).	1 day
Primary	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	Evaluation of the users security	Report accident of drone or users injuries	1 day
Secondary	Evaluation of the users safety	Report numbers of samples broken (contamination risk) after drone transport	1 day
Secondary	Temperature	Temperature measurement during the transport. Evaluation of the ambient temperature respect during the transport in the two conditions.	1 day