Clinical trial NCT04201860: Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Blood Gas
Bleeding Disorder
Keywords: Arterial blood gas
Coagulation
Nitrogen compounds
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers of Blasters and No Blasters Group of the Italian National Mountain and Cave Rescue

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of Italian National Mountain and Cave Rescue

Exclusion Criteria:

* gas exchange disorders
* quantitative abnormalities of coagulation assessment
* qualitative abnormalities of coagulation assessment

Primary outcomes:
measure: Change from baseline arterial blood gases analysis at 2 hours
timeFrame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
measure: Change from baseline haemostasis analysis at 2 hours
timeFrame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Secondary outcomes:
measure: Change from Baseline heart rate at 2 hours
timeFrame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
measure: Change from baseline arterial blood pressure at 2 hours
timeFrame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
measure: Change from baseline pulse oxymetry at 2 hours
timeFrame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
measure: Change from baseline epitympanic temperature at 2 hours
timeFrame: 10 minutes before going in to the cave and two hours after the volunteers come out from the cave
Other outcomes:
Locations:
city: Avezzano
country: Italy
facility: Barbara Pizzi
Study officials:
affiliation: San Salvatore Academic Hospital
name: Emiliano Petrucci, MD
role: STUDY_CHAIR
References: