Clinical trial NCT05887089: Analytical Impact of the Transport of Pathological Biological Material by Drone
Official title: Verification of the Absence of Analytical Impact of the Transport of Pathological Biological Material by Drone Within the Amiens-Picardie University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biological Samples
Keywords: drone transport
biological samples
unmanned aerial system
UAS
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: If eligible for the study, patients from the central blood collection unit and the day hospitals of the CHU Amiens-Picardie will be offered to participate in the study. After information and consent of the patient, blood sampling will be performed to obtain the samples necessary for the normal medical management of the patient, as well as additional tubes corresponding to the same prescribed analyses. The collection of the extra tubes will therefore be done at the same time as the routine collection, without any additional invasive procedure.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: variation of ASAT concentration between both groups
timeFrame: one day
measure: variation of ALAT concentration between both groups
timeFrame: one day
measure: variation of BNP concentration between both groups
timeFrame: one day
measure: variation of LDH concentration between both groups
timeFrame: one day
measure: variation of Glucose concentration between both groups
timeFrame: one day
measure: variation of Troponin concentration between both groups
timeFrame: one day
measure: variation of Potassium concentration between both groups
timeFrame: one day
measure: variation of HIL concentration between both groups
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: