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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding Disorder; Disorder of Blood Gas
• Intervention / Treatment: Diagnostic test: Arterial blood gas analyses and haemostasis measures

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 Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Italy
  • Avezzano, Italy, 67051
    • Barbara Pizzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy volunteers of Blasters and No Blasters Group of the Italian National Mountain and Cave Rescue

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Arterial blood gas analyses and haemostasis measures; 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.
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.	Diagnostic test: Arterial blood gas analyses and haemostasis measures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	10 minutes before going in to the cave and two hours after the volunteers come out from the cave

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline heart rate at 2 hours	Haert rate was recorded by using a multiparametric monitor	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	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	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	10 minutes before going in to the cave and two hours after the volunteers come out from the cave

Collaborators and Investigators

• Sponsor: Emiliano Petrucci
• Investigators: Study Chair: Emiliano Petrucci, MD, San Salvatore Academic Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Actual): November 12, 2018
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Arterial blood gas; Coagulation; Nitrogen compounds
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Disease; Hemorrhage; Hemorrhagic Disorders; Coagulants; Hemostatics
• Other Study ID Numbers: 20/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No