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WithdrawnNCT02455713Updated May 1, 2018

Positive Pressure Ventilation and Sternal Closure in HLHS

An observational study in Hypoplastic Left Heart Syndrome, sponsored by The Hospital for Sick Children. Withdrawn at 1 site in Canada. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by The Hospital for Sick Children · Observational

Why this study was withdrawn
Needed equipment failed before the study was started.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
0
Ages
Up to 1 Month
Sex
All
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Study summary

This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure. Outcome measures include oxygen delivery and cardiac output.

Read the detailed description

The objective of this study is to define the impact of variable levels of PEEP and tidal volume on hemodynamics and lung mechanics around delayed sternal closure after Stage 1 palliation in the single ventricle patient.

The Specific Aims of this work are:

Specific Aim 1: Evaluate hemodynamics and lung mechanics across a range of PEEP (2-12 cm H2O) before and after chest closure, while maintaining consistent ventilation, in infants with single ventricle physiology who undergo delayed sternal closure after Stage 1 palliation surgery.

Specific Aim 2: Evaluate hemodynamics and lung mechanics across a range of tidal volumes (6-15ml/kg) and before and after chest closure, while maintaining consistent ventilation, in infants with single ventricle physiology who undergo delayed sternal closure after Stage 1 palliation surgery.

Hypotheses

  1. The effects of PEEP and tidal volume on hemodynamics and lung mechanics will be significantly different before and after sternal closure. We expect that there will be little effect of PEEP or tidal volume when the sternum remains open. Once the sternum is closed, we hypothesize that those with shunted single ventricle physiology will have optimal oxygen delivery and lung mechanics with modest PEEP and tidal volume (U-shaped curves).

Rationale: Delayed sternal closure is commonly used to prevent tissue tamponade and promote favorable hemodynamics in critically ill patients following surgery for congenital heart disease. This technique is frequently employed in shunted single ventricle physiology (i.e.- Norwood patients). While there have been several studies that have shown that sternal closure is associated with temporary hemodynamic changes and stiffer lung mechanics, there have been no prospective studies of the impact of different ventilator strategies on hemodynamics, and lung mechanics before and after sternal closure. Because these patients are generally among the most fragile postoperative patients, it is critical to understand if specific ventilator strategies can help mitigate any negative hemodynamic consequences of chest closure. The purpose of this study is to understand the critical cardiopulmonary interactions that occur with delayed sternal closure in this population, and to determine optimal approaches to mechanical ventilation under these different circumstances.

Cardiopulmonary interactions differ based on the underlying cardiac anatomy and physiology. Most studies of cardiopulmonary interactions following surgery for congenital heart disease have examined the difference between positive and negative pressure ventilation in those with right ventricular restrictive physiology such as after tetralogy of Fallot repair, or after cavopulmonary connection surgery. This work consistently shows improvement in cardiac output and pulmonary blood flow with negative pressure ventilation. It is not practical, however, to maintain negative pressure ventilation when the sternum remains open and it is not even clear that the same cardiopulmonary interactions are at play in the absence of significant elastic recoil forces of the chest wall.

Similarly, while patients with left ventricular dysfunction generally benefit from positive pressure ventilation, there is no data regarding the hemodynamic effects of positive pressure ventilation in left ventricular dysfunction when intrathoracic pressure will not deviate from atmospheric, which is the situation with delayed sternal closure.

Shunted single ventricle physiology is perhaps the most difficult for which to predict the effects of different ventilator strategies before and after sternal closure. The combination of parallel pulmonary and systemic circulations, less than optimal total cardiac output and, most commonly, at least some pulmonary edema make it difficult to predict the ideal ventilator strategy. Studies in this population have focused more on the effects of FiO2 and hyperventilation than on respiratory mechanics and cardiopulmonary interactions. Nevertheless, this work has shown that the occurrence of pulmonary venous desaturation is common following stage 1 Norwood surgery, and it remains unknown if there is risk or benefit from strategies such as lower or higher tidal volumes or lower or higher PEEP on hemodynamics and oxygen delivery.

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Conditions studied

  • Hypoplastic Left Heart Syndrome
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In context

Hypoplastic Left Heart Syndrome

60 studies on the registry are indexed under Hypoplastic Left Heart Syndrome; 11 are open to participants now.

Browse Hypoplastic Left Heart Syndrome studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants after congenital heart surgery.

Inclusion criteria

  1. All patients who, following stage 1 palliation for single ventricle physiology, undergo delayed sternal closure are eligible to be included in the study

Exclusion criteria

Exclusion Criteria:

  1. History of pneumothorax, acute respiratory distress syndrome, or other contraindication to the proposed ventilator manipulations as determined by the responsible CCCU staff physician.
  2. Endotracheal tube leak > 15%.
  3. Lack of informed consent from parents.
  4. Weight less than 2.6kg
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Intervention

    Alter PEEP and PIP and measure hemodynamic outcomes.

    Device: PEEP and PIP

Interventions

  • DevicePEEP and PIP

    Changing ventilator settings and measuring oxygen delivery and cardiac output

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What researchers measure

Primary outcomes

  1. Oxygen Delivery calculated from direct measurements of oxygen consumption via respiratory mass spectrometry

    Oxygen delivery will be calculated from direct measurements of oxygen consumption via respiratory mass spectrometry and estimates of cardiac output calculated using the Fick equation from measured arterial a venous blood gas samples.

    Time frame: Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.

Secondary outcomes

  1. Cardiac Output calculated using the Fick Equation

    Cardiac output will be calculated using the Fick Equation from direct measurement of oxygen consumption using respiratory mass spectrometry and arterial and venous blood gas samples.

    Time frame: Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.

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Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02455713
Lead sponsor
The Hospital for Sick Children
Responsible party
Steven Schwartz (Professor of Paediatrics, The Hospital for Sick Children) — Principal investigator
First posted
May 28, 2015
Start date
Feb 2015
Primary completion
Dec 2016 (estimated)
Completion
Jun 2017 (estimated)
Last update
May 1, 2018

Study contacts

Steven Schwartz, MD
principal investigator · The Hospital for Sick Children, Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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