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Completed

NCT Number: NCT04201860

Blood Gas and Bleeding Disorders in Healthy Volunteers Exposed to Nitroglycerin and Nitrogen Compounds

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.

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Key information

Conditions

Disorder of Blood Gas Bleeding Disorder Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Thrombosis Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barbara Pizzi

Avezzano, 67051, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial blood gas analyses and haemostasis measures

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

    Haert rate was recorded by using a multiparametric monitor

  2. 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

    Arterial blood pressure was recorded by using a multiparametric monitor

  3. 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

    Pulse oxymetry was recorded by using a multiparametric monitor

  4. 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

    Epitympanic temperature was measured by using epitympanic probe

Sponsors and collaborators

Lead sponsor

Emiliano Petrucci

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 17, 2019
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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