NCT05957497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 5, 2024

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

March 23, 2023

Last Update Submit

March 4, 2024

Conditions

Healthy

Keywords

Sample transportDronePre-Analytical Phase

Outcome Measures

Primary Outcomes (27)

  • 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 Outcomes (3)

  • Evaluation of the users security

    1 day

  • Evaluation of the users safety

    1 day

  • Temperature

    1 day

Study Arms (2)

Pedestrian transport

Modality of transport currently used

Biological: Biological samples transport and analysis

Drone transport

Innovative modality of transport

Biological: Biological samples transport and analysis

Interventions

Biological samples transport and analysisBIOLOGICAL

Biological samples transport and analysis

Drone transportPedestrian transport

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Healthy volunteers, over 18 years old

You may not qualify if:

  • Unhealthy volunteers previously known
  • pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Caen Normandie

Caen, 14000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Officials

  • Benjamin GILLET, MD

    CHU CAEN NORMANDIE

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

July 24, 2023

Study Start

April 27, 2023

Primary Completion

August 27, 2023

Study Completion

August 30, 2023

Last Updated

March 5, 2024

Record last verified: 2023-06

Locations

FR(1)