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.
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.
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
- 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.
- Conditions
- Hypoplastic Left Heart Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Alter 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.
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)
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.
- First posted28 May 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Needed equipment failed before the study was started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Schwartz, The Hospital for Sick Children
- Investigators
- Steven Schwartz, MD, Principal investigator, The Hospital for Sick Children, Toronto
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive Pressure Ventilation on Hemodynamics Around Delayed Sternal Closure Following Stage 1 Palliation of the Single Ventricle
- ClinicalTrials.gov ID
- NCT02455713
- Acronym / sponsor ID
- 1000047473
- Conditions
- Hypoplastic Left Heart Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Needed equipment failed before the study was started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: PEEP and PIPAlter PEEP and PIP and measure hemodynamic outcomes. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants after congenital heart surgery.
Key inclusion criteria (1 listed)
- 1. All patients who, following stage 1 palliation for single ventricle physiology, undergo delayed sternal closure are eligible to be included in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP and PIPChanging ventilator settings and measuring oxygen delivery and cardiac output | Device | Intervention |
Primary outcome
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.
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.
1 secondary outcome
Cardiac Output calculated using the Fick Equation
Time frame: Measurements made 15 minutes after each ventilator change. Total duration of observation is 2.5 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Schwartz, MD principal investigator
The Hospital for Sick Children, Toronto
1 site in 1 country: see every site and its status.
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.