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

Completed

• Conditions: Disorder of Blood Gas; Bleeding Disorder
• Interventions: Diagnostic Test: Arterial blood gas analyses and haemostasis measures

• Registration Number: NCT04201860
• Lead Sponsor: Emiliano Petrucci

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.

Study Timeline

• Study Start: 2016-12-12
• Primary Completion: 2018-11-12
• Study Completion: 2019-12-12
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Not blasters group	Arterial blood gas analyses and haemostasis measures	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.
Blasters group	Arterial blood gas analyses and haemostasis measures	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline haemostasis analysis at 2 hours	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
Change from baseline arterial blood gases analysis at 2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline arterial blood pressure at 2 hours	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
Change from baseline pulse oxymetry at 2 hours	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
Change from Baseline heart rate at 2 hours	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
Change from baseline epitympanic temperature at 2 hours	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

Trial Locations

Locations (1)

Barbara Pizzi; 🇮🇹 Avezzano, Italy