Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure

October 28, 2013 updated by: Jakub Honek, MD, University Hospital, Motol
The aim of this study is to determine whether catheter-based closure of patent foramen ovale is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim of this study is to determine whether catheter-based closure of patent foramen ovale (PFO) is effective in preventing paradoxical embolization of nitrogen bubbles after simulated dives.

Ultrasonographic detection of venous and arterial nitrogen bubbles will be performed in divers after surfacing from simulated dives in hyperbaric chambers. Divers will be observed after two different dive profiles - Dive A (dive to 18 m for 80 min bottom time) and dive B (dive to 50 m for 20 min bottom time), both performed according to US Navy Air decompression procedure 1996. For both dives two groups will be compared: Divers with PFO and divers after previous catheter-based closure of PFO.

The study will be observational. Sonographic detection of bubbles will be performed after simulated dives that are part of a training program of the divers. Two different dives, previously documented to generate significant amount of venous nitrogen bubbles, were chosen.

The primary end-point will be a positive transcranial doppler test (defined as one or more bubbles detected either during native breathing or after Valsalva maneuver).

Inclusion criteria are: 1) previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure, 2) signed informed consent

Exclusion criteria: 1) another dive performed in the preceding 24 hours, 2) another previously diagnosed right-to-left shunt, 3) disagreement to be included in the study

This study will be single-center.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 15006
        • Department of Cardiology, University Hospital Motol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult scuba divers with either a previously diagnosed patent foramen ovale (PFO) or after a catheter-based PFO closure. Consecutive divers that undergo a simulated dive in hyperbaric chamber will be recruited.

Description

Inclusion Criteria:

  1. previously diagnosed PFO or a PFO that has been occluded by a catheter-based procedure
  2. signed informed consent

Exclusion criteria:

  1. another dive performed in the preceding 24 hours
  2. another previously diagnosed right-to-left shunt
  3. disagreement to be included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patent foramen ovale dive A group
Divers with a previously diagnosed patent foramen ovale observed after Dive A.
Closure dive A group
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
patent foramen ovale dive B group
Divers with a previously diagnosed patent foramen ovale observed after Dive B.
closure dive B group
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Nitrogen Bubbles After Surfacing
Time Frame: assesed within 1 hour after surfacing
Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.
assesed within 1 hour after surfacing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Investigators

  • Study Chair: Josef Veselka, MD, PhD, Department of cardiology, UH Motol
  • Study Director: Jakub Honek, MD, Department of cardiology, UH Motol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-1929/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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