HealthyDBTNCT05957497
Drone Biological Samples Transport vs Walking (DBT - Drone Biology Transport)
An observational study of Healthy, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Biological samples transport and analysis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Healthy volunteers, over 18 years old
Who cannot join
- Unhealthy volunteers previously known
- pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy
- Being tested
- Biological samples transport and analysis
- Keywords
- Sample transport, Drone, Pre-Analytical Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples transport and analysisBiological
Biological samples transport and analysis
| Study group | Role | What they receive |
|---|---|---|
| Pedestrian transport | Modality of transport currently used Receives: Biological: Biological samples transport and analysis | |
| Drone transport | Innovative modality of transport Receives: Biological: Biological samples transport and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Sodium test
Evaluation difference between results of Sodium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Potassium test
Evaluation difference between results of Potassium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Chlorure test
Evaluation difference between results of Chlorure (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Bicarbonate test
Evaluation difference between results of Bicarbonate (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Protein test
Evaluation difference between results of Protein (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Calcium test
Evaluation difference between results of Calcium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Creatinin test
Evaluation difference between results of Creatinin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Urea test
Evaluation difference between results of Urea (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Albumin test
Evaluation difference between results of Albumin (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on Bilirubin test
Evaluation difference between results of Bilirubin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 day
Impact on GGT test
Evaluation difference between results of GGT (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 1 day
Impact on LDH test
Evaluation difference between results of LDH (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 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).
Measured: 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).
Measured: 1 day
Impact on hemoglobin test
Evaluation difference between results of hemoglobin (g/dL) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 day
Impact on platelets count
Evaluation difference between results of platelets (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 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).
Measured: 1 day
Impact on PT test
Evaluation difference between results of PT (sec and %) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 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).
Measured: 1 day
Impact on Fibrinogen test
Evaluation difference between results of Fibrinogen (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Measured: 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).
Measured: 1 day
Secondary outcomes (3)
Evaluation of the users security
Report accident of drone or users injuries
Measured: 1 day
Evaluation of the users safety
Report numbers of samples broken (contamination risk) after drone transport
Measured: 1 day
Temperature
Temperature measurement during the transport. Evaluation of the ambient temperature respect during the transport in the two conditions.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start27 Apr 2023
- Primary completion27 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin GILLET, MD, Study chair, CHU CAEN NORMANDIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957497
- Sponsor's protocol ID
- 22-0238
- Other IDs
- 2022-A02548-35
- Acronym
- DBT
- Status last verified
- Jun 2023
- First submitted
- 23 Mar 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drone Biological Samples Transport Evaluation Compared to Walking in CHU CAEN NORMANDIE
- ClinicalTrials.gov ID
- NCT05957497
- Acronym / sponsor ID
- DBT / 22-0238
- Conditions
- Healthy
- Keywords
- Sample transport, Drone, Pre-Analytical Phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedestrian transport | – | Biological: Biological samples transport and analysisModality of transport currently used |
| Drone transport | – | Biological: Biological samples transport and analysisInnovative modality of transport |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- Healthy volunteers, over 18 years old
Key exclusion criteria (2 listed)
- Unhealthy volunteers previously known
- pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samples transport and analysisBiological samples transport and analysis | Biological | Drone transport, Pedestrian transport |
Primary outcome
Impact on Sodium test
Time frame: 1 day
Evaluation difference between results of Sodium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Potassium test
Time frame: 1 day
Evaluation difference between results of Potassium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Chlorure test
Time frame: 1 day
Evaluation difference between results of Chlorure (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Bicarbonate test
Time frame: 1 day
Evaluation difference between results of Bicarbonate (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Protein test
Time frame: 1 day
Evaluation difference between results of Protein (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Calcium test
Time frame: 1 day
Evaluation difference between results of Calcium (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Creatinin test
Time frame: 1 day
Evaluation difference between results of Creatinin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Urea test
Time frame: 1 day
Evaluation difference between results of Urea (mmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Albumin test
Time frame: 1 day
Evaluation difference between results of Albumin (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Bilirubin test
Time frame: 1 day
Evaluation difference between results of Bilirubin (µmol/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on liver transaminase (ALT) test
Time frame: 1 day
Evaluation difference between results of liver transaminase (ALT, U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on liver transaminase (AST) test
Time frame: 1 day
Evaluation difference between results of liver transaminase (AST, U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on alkalin phosphatase test
Time frame: 1 day
Evaluation difference between results of alkalin phosphatase (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on GGT test
Time frame: 1 day
Evaluation difference between results of GGT (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on LDH test
Time frame: 1 day
Evaluation difference between results of LDH (U/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on C-reactive Protein test
Time frame: 1 day
Evaluation difference between results of C-reactive Protein (mg/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on red blood cells count
Time frame: 1 day
Evaluation difference between results of red blood cells (T/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on hemoglobin test
Time frame: 1 day
Evaluation difference between results of hemoglobin (g/dL) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on white blood cells count
Time frame: 1 day
Evaluation difference between results of white blood cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on neutrophil cells count
Time frame: 1 day
Evaluation difference between results of neutrophil cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on lymphocytes cells count
Time frame: 1 day
Evaluation difference between results of lymphocytes cells (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on platelets count
Time frame: 1 day
Evaluation difference between results of platelets (G/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on sedimentation rate test
Time frame: 1 day
Evaluation difference between results of sedimentation rate (mm) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on PT test
Time frame: 1 day
Evaluation difference between results of PT (sec and %) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on a-PTT test
Time frame: 1 day
Evaluation difference between results of a-PTT (sec) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on Fibrinogen test
Time frame: 1 day
Evaluation difference between results of Fibrinogen (g/L) after drone transport (30 samples) versus pedestrian transport (30 samples).
Impact on D-Dimer test
Time frame: 1 day
Evaluation difference between results of D-Dimer (ng/mL) after drone transport (30 samples) versus pedestrian transport (30 samples).
3 secondary outcomes
Evaluation of the users security
Time frame: 1 day
Evaluation of the users safety
Time frame: 1 day
Temperature
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin GILLET, MD study chair
CHU CAEN NORMANDIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on Sodium test (time frame: 1 day). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.