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Hypoplastic Left Heart SyndromeNCT02455713

Positive Pressure Ventilation and Sternal Closure in HLHS

An observational study of Hypoplastic Left Heart Syndrome, run by The Hospital for Sick Children at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 more about this study

Who is it for?
Ages Up to 1 month
Conditions the study is for
Hypoplastic Left Heart Syndrome
What is being tested?
PEEP and PIP
Type of treatment
Medical device
How many people
0 participants
Where
1 siteCanada
Study dates
Feb 2015to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 1 month
  • All sexes
  • No healthy volunteers
  • Child

Study population: Infants after congenital heart surgery.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: Effect of Positive Pressure Ventilation on Hemodynamics Around Delayed Sternal Closure Following Stage 1 Palliation of the Single Ventricle

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.

Being tested
PEEP and PIP
Medical subject headings
Hypoplastic Left Heart Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEP and PIPDevice

    Changing ventilator settings and measuring oxygen delivery and cardiac output

Study groups in NCT02455713
Study groupRoleWhat they receive
InterventionAlter PEEP and PIP and measure hemodynamic outcomes.
Receives: Device: PEEP and PIP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Why it stopped: Needed equipment failed before the study was started.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02455713
Sponsor's protocol ID
1000047473
Status last verified
Apr 2018
First submitted
5 Apr 2015
Last updated
1 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypoplastic Left Heart Syndrome, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Delivery calculated from direct measurements of oxygen consumption via respiratory mass spectrometry (time frame: Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.

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