Analytical Impact of the Transport of Pathological Biological Material by Drone

Biological Samples Clinical Trial

— PATH-AIRCHU  

Official title:

Verification of the Absence of Analytical Impact of the Transport of Pathological Biological Material by Drone Within the Amiens-Picardie University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887089
• Other study ID #: PI2023_843_0030
• Status: Recruiting
• Start date: May 22, 2023
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Baptiste Demey, PharmD
• Phone: 03 22 08 70 65
• Email: demey.baptiste[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Hospital Group of Territory Somme Littoral Sud, through its biology sector and in partnership with the company DELIVRONE, aims to engage in the experiment of transporting biological samples by means of a drone platform. Transport by air will be between the CHAM, the Abbeville Hospital and the CHU Amiens-Picardie by flying as much as possible over the waterways via the Somme. With a flight speed of around 100km/h at an altitude between 80 and 120 m, drones will be able to connect sites in less than an hour by transporting packages between 2 and 3 kg. Powered by propellers connected to rechargeable batteries, these drones do not emit CO2. This type of transport has not been validated in France by measuring the analytical impact of transport constraints for medical biology, and has never been evaluated according to the criteria of ISO 15189 standard allowing the certification of medical biology laboratories. Validation steps of this transportation method are therefore necessary on pathological samples prior to routine use. The aim of the project is to verify the absence of analytical impact of the transport of pathological biological samples by drone under defined flight conditions, according to the ISO15189 norm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to the Amiens-Picardie University Hospital and having benefited from medical biology examinations including the parameters of interest
• according to the usual management modalities and without additional sampling
• at the time of the test period

Exclusion Criteria:

• Refusal to participate in the study

Related Conditions & MeSH terms

• Biological Samples

Intervention

Other:
• drone transport
additional transport of samples at room temperature by drone (departure from the CHU Amiens-Picardie, 1 hour flight in the CHU Amiens-Picardie air perimeter, return to the CHU Amiens-Picardie)

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of ASAT concentration between both groups		one day
Primary	variation of ALAT concentration between both groups		one day
Primary	variation of BNP concentration between both groups		one day
Primary	variation of LDH concentration between both groups		one day
Primary	variation of Glucose concentration between both groups		one day
Primary	variation of Troponin concentration between both groups		one day
Primary	variation of Potassium concentration between both groups		one day
Primary	variation of HIL concentration between both groups		one day