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

Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201860
• Other study ID #: 20/2016
• Status: Completed
• Start date: December 12, 2016
• Est. completion date: December 12, 2019

Study information

• Verified date: February 2020
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 12, 2019
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Disease
• Disorder of Blood Gas
• Hemorrhage
• Hemorrhagic Disorders
• Hemostatic Disorders

Intervention

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.

Locations

Country	Name	City	State
Italy	Barbara Pizzi	Avezzano

Sponsors (1)

Lead Sponsor	Collaborator
Emiliano Petrucci

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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