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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04201860
Other study ID # 20/2016
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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