Clinical Trial: Sleep Disordered Breathing in Children With Single Ventricle Physiology
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational
Official Title: Sleep Disordered Breathing in Children With Single Ventricle Physiology
Brief Summary:
This is an exploratory study designed to evaluate the incidence of, and to quantify sleep disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered breathing will be correlated with:
- Elevations in pulmonary vasculature resistance at the time of Stage II surgery.
- Risks of death
Detailed Summary:
This is an exploratory study designed to evaluate the incidence of, and to quantify sleep disordered breathing following stage I Norwood reconstructive surgery. Sleep disordered breathing will be correlated with:
- Elevations in pulmonary vasculature resistance at the time of Stage II surgery.
- Risks of death
Children with single ventricle physiology are exquisitely sensitive to alterations in pulmonary vascular resistance. Following their first operative repair (stage I Norwood), performed in their first week of life, pulmonary and systemic circulations are in parallel rather than series. As such, elevations in pulmonary vascular resistance can result in severe arterial desaturation. Additionally, elevated pre-operative pulmonary artery pressure is directly correlated with poor survival following the third and final operative repair (stage III Norwood, or Fontan).
Periodic breathing is a normal breathing pattern in sleeping infants. At the other end of the spectrum is sleep apnea. In between lies a continuum of sleep disordered breathing. Obstructive sleep apnea has an incidence of approximately 2% in children, and is associated with pulmonary and systemic hypertension. Specific studies of the incidence and effects of sleep disordered breathing in congenital heart disease are lacking. Otherwise normal children have baseline oxygen saturation in the high 90's, thereby placing them on the flat part of the oxyhemoglobin curve. But children with cyanotic congenital heart disease live with baseline oxygen saturations in the mid 70's, so that they exist on the steep part of the oxyhemoglobin dissociation curve. We hypothesize therefore that these patients are at increased risk for the hemodynamic variations o
Sponsor: University of Rochester
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Rochester
Dates:
Date Received: September 8, 2005
Date Started: September 2004
Date Completion:
Last Updated: April 29, 2015
Last Verified: April 2015
