Disorder of Blood GasNCT04201860
Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds
An observational study of Disorder of Blood Gas and Bleeding Disorder, run by Emiliano Petrucci at 1 site in Italy.
Trial summary
The aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Blood Gas, Bleeding Disorder
- What is being tested?
- Arterial blood gas analyses and haemostasis measures
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2016to 12 Dec 2019
- How long will I take part?
- 1 Day
- 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 of Blasters and No Blasters Group of the Italian National Mountain and Cave Rescue
Who may be able to join
- Healthy volunteers of Italian National Mountain and Cave Rescue
Who cannot join
- gas exchange disorders
- quantitative abnormalities of coagulation assessment
- qualitative abnormalities of coagulation assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds of Blasting Gelatin: a Field Report During a Cave Accident
The aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.
Read the detailed description
This was a field report of clinical data collected during an accidental uncontrolled detonation of micro-charges, while the cave unblocking procedure was performed by volunteers of blaster group and non blasters group of the Italian National Mountain and Cave Rescue, in a cave in Trieste (Italy; altitude entrance: 348 meters above sea level; total length: 413,5 meters; total depth of 307 meters).
Before going into the cave (Time 0), the following clinical data were collected: age, sex, body mass index; smoke (yes/no), heart rate, arterial blood pressure (mean arterial pressure), oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures.
After the accidental uncontrolled detonation of micro-charges, (Time 1) heart rate, arterial blood pressure, oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures were recorded in each volunteers.
- Conditions
- Disorder of Blood Gas, Bleeding Disorder
- Being tested
- Arterial blood gas analyses and haemostasis measures
- Keywords
- Arterial blood gas, Coagulation, Nitrogen compounds
- Medical subject headings
- Hemostatic Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gas analyses and haemostasis measuresDiagnostic test
Under aseptic conditions, a puncture of radial artery was performed: three mL of the arterial blood sample were used for the haemostasis measure, while one mL was tested for the blood gases analysis.
| Study group | Role | What they receive |
|---|---|---|
| Blasters group | The volunteers of the blasters group of Italian Mountain and Cave Rescue handled explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation. Receives: Diagnostic Test: Arterial blood gas analyses and haemostasis measures | |
| Not blasters group | The volunteers of the blasters group of Italian Mountain and Cave Rescue did not handle explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation. Receives: Diagnostic Test: Arterial blood gas analyses and haemostasis measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline arterial blood gases analysis at 2 hours
Under aseptic conditions, a puncture of radial artery was performed: one mL was tested for the blood gases analysis, by using i-STAT analyser.
Measured: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline haemostasis analysis at 2 hours
Under aseptic conditions, a venipuncture was performed: three mL of blood sample were used for the haemostasis measure, by using Rotational Thromboelastometry
Measured: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Secondary outcomes (4)
Change from Baseline heart rate at 2 hours
Haert rate was recorded by using a multiparametric monitor
Measured: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline arterial blood pressure at 2 hours
Arterial blood pressure was recorded by using a multiparametric monitor
Measured: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline pulse oxymetry at 2 hours
Pulse oxymetry was recorded by using a multiparametric monitor
Measured: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline epitympanic temperature at 2 hours
Epitympanic temperature was measured by using epitympanic probe
Measured: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start12 Dec 2016
- Primary completion12 Nov 2018
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Blood GasStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 94 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Emiliano Petrucci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Emiliano Petrucci, MD, Study chair, San Salvatore Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201860
- Sponsor's protocol ID
- 20/2016
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds of Blasting Gelatin: a Field Report During a Cave Accident
- ClinicalTrials.gov ID
- NCT04201860
- Acronym / sponsor ID
- 20/2016
- Conditions
- Disorder of Blood Gas, Bleeding Disorder
- Keywords
- Arterial blood gas, Coagulation, Nitrogen compounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Emiliano PetrucciUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 17 Dec 2019 (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 aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the Italian National Mountain and Cave Rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.
Detailed description
This was a field report of clinical data collected during an accidental uncontrolled detonation of micro-charges, while the cave unblocking procedure was performed by volunteers of blaster group and non blasters group of the Italian National Mountain and Cave Rescue, in a cave in Trieste (Italy; altitude entrance: 348 meters above sea level; total length: 413,5 meters; total depth of 307 meters).
Before going into the cave (Time 0), the following clinical data were collected: age, sex, body mass index; smoke (yes/no), heart rate, arterial blood pressure (mean arterial pressure), oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures.
After the accidental uncontrolled detonation of micro-charges, (Time 1) heart rate, arterial blood pressure, oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures were recorded in each volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blasters group | – | Diagnostic Test: Arterial blood gas analyses and haemostasis measuresThe volunteers of the blasters group of Italian Mountain and Cave Rescue handled explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation. |
| Not blasters group | – | Diagnostic Test: Arterial blood gas analyses and haemostasis measuresThe volunteers of the blasters group of Italian Mountain and Cave Rescue did not handle explosive with nitrogen compounds and nitroglycerin of micro-charges, before the accidental uncontrolled detonation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers of Blasters and No Blasters Group of the Italian National Mountain and Cave Rescue
Key inclusion criteria (1 listed)
- Healthy volunteers of Italian National Mountain and Cave Rescue
Key exclusion criteria (3 listed)
- gas exchange disorders
- quantitative abnormalities of coagulation assessment
- qualitative abnormalities of coagulation assessment
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 |
|---|---|---|
| Arterial blood gas analyses and haemostasis measuresUnder aseptic conditions, a puncture of radial artery was performed: three mL of the arterial blood sample were used for the haemostasis measure, while one mL was tested for the blood gases analysis. | Diagnostic test | Blasters group, Not blasters group |
Primary outcome
Change from baseline arterial blood gases analysis at 2 hours
Time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Under aseptic conditions, a puncture of radial artery was performed: one mL was tested for the blood gases analysis, by using i-STAT analyser.
Change from baseline haemostasis analysis at 2 hours
Time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Under aseptic conditions, a venipuncture was performed: three mL of blood sample were used for the haemostasis measure, by using Rotational Thromboelastometry
4 secondary outcomes
Change from Baseline heart rate at 2 hours
Time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline arterial blood pressure at 2 hours
Time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline pulse oxymetry at 2 hours
Time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Change from baseline epitympanic temperature at 2 hours
Time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
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 26 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Disorder of Blood Gas
Not yet recruitingPhase 3
Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
Chronic Respiratory Diseases
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
Recruiting
Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE
Pulmonary Disease (COPD), Chronic Obstructive
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.
Emiliano Petrucci, MD study chair
San Salvatore Academic Hospital
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 Disorder of Blood Gas and Bleeding Disorder, run by Emiliano Petrucci at 1 site in Italy.
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 3 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 26 Feb 2020. 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 Italy. 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?
Change from baseline arterial blood gases analysis at 2 hours (time frame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave). The study lists 2 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 26 Feb 2020.