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Completed

NCT Number: NCT01854281

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

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.

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Key information

Conditions

Patent Foramen Ovale Barotrauma Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Decompression Sickness Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Hospital Motol

Prague, 15006, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • another dive performed in the preceding 24 hours
  • another previously diagnosed right-to-left shunt
  • disagreement to be included in the study

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 15, 2013
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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