Perfusion PressuresNCT01117883
Sternal Wall Pressure in the Cath Lab
A study testing Application of two different sternal weights in people with Perfusion Pressures and Central Venous Pressure, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure in order to inform the… Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Perfusion Pressures, Central Venous Pressure, Cardiac Output
- What is being tested?
- Application of two different sternal weights
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2011
- Phase
- Interventional
- 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 6 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 months to < 8 years.
- Weight 5 to 50 kilograms.
- Hemodynamically stable (pre-anesthetic vital signs will be within normal range of expected for age and stability during the procedure is defined as no fluctuation in heart rate or blood pressure >20%. Ultimate determination of hemodynamic stability for inclusion will be defined by the attending Anesthesiologists and Interventional Cardiologists involved in the procedure)
- Volume Limited Ventilation Mode on Conventional Mechanical Ventilator using either cuffed or uncuffed endotracheal tubes with minimal leak (leak >30 mmHg).
- Heart transplant recipients presenting for a routine, scheduled, surveillance cardiac catheterization per standard clinical protocol.
- Greater than 6 months removed from date of cardiac transplant.
- Normal cardiac function (defined as a shortening fraction of ≥ 30% or qualitatively described as "normal" if a m-mode shortening fraction was not obtained) with normal function of all valves (defined as insufficiency of all valves as either "none", "trivial", or "mild") on their pre-procedure echocardiogram.
Who cannot join
- Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery or chest tube in place)
- Patients with an implantable pacemaker or AICD.
- Patients on beta blockers.
- Patients not in normal sinus rhythm on their pre-procedural ECG.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures.
- Non-English speaking families
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Gentle Sternal Chest Wall Pressure on Central Hemodynamic Measurements and Intrathoracic Pressure During Mechanical Ventilation in Children
This protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure in order to inform the resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR.
Read the detailed description
STUDY RATIONALE The critical importance of positive and negative intrathoracic pressures during Cardiopulmonary Resuscitation (CPR) has been recently demonstrated. During CPR, excessive positive intrathoracic pressure caused by overzealous ventilation or incomplete chest wall decompression has a detrimental effect on venous return to the heart, cardiac hemodynamics, and survival in adults. FDA-approved monitor/defibrillators with sensors that detect and provide feedback on the quality of chest compressions, including the amount of sternal pressure ("leaning"), can improve the quality of CPR in adults. These monitor/defibrillators have recently been implemented in the PICU and ED at CHOP. However, determining whether "leaning" (or gentle sternal pressure) affects return of venous blood to the thorax and intrathoracic pressure in children is unknown. A pilot study to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure would be a first step toward informing the resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR.
STUDY OBJECTIVE(S)
- To characterize the effect of the application of two different weights on the sternum known to approximate "leaning" during CPR on central hemodynamic measurements and coronary perfusion pressures in mechanically ventilated children.
- To characterize the effect of the application of two different weights on the sternum known to approximate "leaning" during CPR on intrathoracic pressure in mechanically ventilated children STUDY DESIGN This protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia.
STUDY PHASES Screening: Prospective patients enrolled will be screened by a co-investigator. Those that meet inclusion criteria will be approached by a member of the investigative team during the routine pre-procedure evaluation in the Cardiac Intake Center for discussion of the study and informed consent.
Phase 1: We will measure the depth of the chest. We will measure central hemodynamic pressures and function, coronary perfusion pressures and intrathoracic pressures as two weights (10% and 20% of body weight) are placed on the sternum. The primary outcome variable will be the change in any of the central hemodynamic measurements before and after each weight is applied to the sternum.
- Being tested
- Application of two different sternal weights
- Keywords
- Perfusion pressures, central venous pressure, cardiac output, CPR, cardiac arrest, Leaning, incomplete release
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of two different sternal weightsOther
Two separate weights (first 10% of body weight, then 20% of body weight) will be placed on the sternum and changes in central hemodynamic measurements and intrathoracic pressure will be recorded and documented.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in central hemodynamic measurements with application of two different sternal weights.
Measured: 1 yr
Secondary outcomes (1)
The secondary endpoint is the change in end-expiratory intrathoracic pressure with application of two different sternal weights.
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion PressuresStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Foundation for Acute Care Medicine
- Investigators
- Andy Glatz, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117883
- Sponsor's protocol ID
- 09-007428
- Status last verified
- Jul 2011
- First submitted
- 4 May 2010
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gentle Sternal Chest Wall Pressure on Central Hemodynamic Measurements and Intrathoracic Pressure During Mechanical Ventilation in Children
- ClinicalTrials.gov ID
- NCT01117883
- Acronym / sponsor ID
- 09-007428
- Keywords
- Perfusion pressures, central venous pressure, cardiac output, CPR, cardiac arrest, Leaning, incomplete release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Laerdal Foundation for Acute Care Medicine
- Study start
- Apr 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 May 2010 (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 protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure in order to inform the resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR.
Detailed description
STUDY RATIONALE The critical importance of positive and negative intrathoracic pressures during Cardiopulmonary Resuscitation (CPR) has been recently demonstrated. During CPR, excessive positive intrathoracic pressure caused by overzealous ventilation or incomplete chest wall decompression has a detrimental effect on venous return to the heart, cardiac hemodynamics, and survival in adults. FDA-approved monitor/defibrillators with sensors that detect and provide feedback on the quality of chest compressions, including the amount of sternal pressure ("leaning"), can improve the quality of CPR in adults. These monitor/defibrillators have recently been implemented in the PICU and ED at CHOP. However, determining whether "leaning" (or gentle sternal pressure) affects return of venous blood to the thorax and intrathoracic pressure in children is unknown. A pilot study to determine whether or not two increments of sternal pressure known to occur during "leaning" in CPR affects hemodynamic function, coronary perfusion pressures, and intrathoracic pressure would be a first step toward informing the resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR.
STUDY OBJECTIVE(S)
- To characterize the effect of the application of two different weights on the sternum known to approximate "leaning" during CPR on central hemodynamic measurements and coronary perfusion pressures in mechanically ventilated children.
- To characterize the effect of the application of two different weights on the sternum known to approximate "leaning" during CPR on intrathoracic pressure in mechanically ventilated children STUDY DESIGN This protocol is a prospective interventional pilot study at the Children's Hospital of Philadelphia.
STUDY PHASES Screening: Prospective patients enrolled will be screened by a co-investigator. Those that meet inclusion criteria will be approached by a member of the investigative team during the routine pre-procedure evaluation in the Cardiac Intake Center for discussion of the study and informed consent.
Phase 1: We will measure the depth of the chest. We will measure central hemodynamic pressures and function, coronary perfusion pressures and intrathoracic pressures as two weights (10% and 20% of body weight) are placed on the sternum. The primary outcome variable will be the change in any of the central hemodynamic measurements before and after each weight is applied to the sternum.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 6 months to < 8 years.
- Weight 5 to 50 kilograms.
- Hemodynamically stable (pre-anesthetic vital signs will be within normal range of expected for age and stability during the procedure is defined as no fluctuation in heart rate or blood pressure >20%. Ultimate determination of hemodynamic stability for inclusion will be defined by the attending Anesthesiologists and Interventional Cardiologists involved in the procedure)
- Volume Limited Ventilation Mode on Conventional Mechanical Ventilator using either cuffed or uncuffed endotracheal tubes with minimal leak (leak >30 mmHg).
- Heart transplant recipients presenting for a routine, scheduled, surveillance cardiac catheterization per standard clinical protocol.
Key exclusion criteria (6 listed)
- Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery or chest tube in place)
- Patients with an implantable pacemaker or AICD.
- Patients on beta blockers.
- Patients not in normal sinus rhythm on their pre-procedural ECG.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures.
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 |
|---|---|---|
| Application of two different sternal weightsTwo separate weights (first 10% of body weight, then 20% of body weight) will be placed on the sternum and changes in central hemodynamic measurements and intrathoracic pressure will be recorded and documented. | Other | – |
Primary outcome
The primary endpoint is the change in central hemodynamic measurements with application of two different sternal weights.
Time frame: 1 yr
1 secondary outcome
The secondary endpoint is the change in end-expiratory intrathoracic pressure with application of two different sternal weights.
Time frame: 1 yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
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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.
Andy Glatz, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of two different sternal weights in people with Perfusion Pressures and Central Venous Pressure, run by Children's Hospital of Philadelphia at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 14 Jul 2011. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is the change in central hemodynamic measurements with application of two different sternal weights. (time frame: 1 yr). 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 14 Jul 2011.