Respiration, ArtificialSWPNCT00628407
Effects of Sternal Wall Pressure in Children
An observational study of Respiration, Artificial, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR) settings at the Children's Hospital of Philadelphia (CHOP). Read more about this study
- Who is it for?
- Ages 6 months to 7 years
- Conditions the study is for
- Respiration, Artificial
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Any patient in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable, mechanically ventilated children in the Children's Hospital of Philadelphia.
Who may be able to join
- Age 6 months to < 8 years.
- Weight greater than 4.8 kg.
- Hemodynamically stable (defined by the Pediatric Critical Care Team, Anesthesiologists and Surgeons)
- Volume Limited Ventilation Mode on Conventional Mechanical Ventilator
- Vascular catheters in place (for at least 10 subjects)
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery, chest tube in place)
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 Intrathoracic Pressure During Mechanical Ventilation in Children.
This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR) settings at the Children's Hospital of Philadelphia (CHOP). We propose to observe, measure and report the effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other surrogates of hemodynamic function, in stable mechanically ventilated children. This study will provide preliminary data to inform the resuscitation research community and assist development of evidence-based pediatric resuscitation guidelines in the future.
Read the detailed description
Context: Survival outcome following cardiac arrest in children is poor, and recent evidence suggests that the quality of Cardiopulmonary Resuscitation(CPR) is critically important. Venous blood return to the thorax to refill the heart is essential for good quality CPR and critical organ perfusion. Adult cardiac arrest studies suggest that incomplete chest wall decompression (i.e. "leaning" on the sternum of the chest) during CPR affects intrathoracic pressure and impedes venous return. The consequence of "leaning" on the chest during CPR is increased intrathoracic pressure, which creates a "back-pressure" preventing optimal return of blood to the heart. The critical importance of manipulating positive and negative intrathoracic pressures during Cardiopulmonary Resuscitation (CPR) has been recently demonstrated in both animal and human studies. Food and Drug Administration (FDA) approved defibrillators with a force and depth sensor can monitor the depth, rate and complete release of sternal pressure during CPR. These FDA approved defibrillators have been introduced and implemented in the Pediatric Intensive Care Unit (PICU) at the Children's Hospital of Philadelphia (CHOP). These defibrillators can provide feedback on the force and amount of "leaning", but there is no data on the minimal amount of sternal pressure (or "leaning pressure") that affects intrathoracic or intravascular pressures or venous return to the heart. In addition, there is no data on how much force on the sternal pressure sensor (e.g. leaning on the sensor) begins to affect intrathoracic pressure in children. We propose to observe, measure and report the effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other surrogates of hemodynamic function, in stable but critically ill and mechanically ventilated children. This study will provide preliminary data to inform the resuscitation research community and assist development of evidence-based pediatric resuscitation guidelines in the future.
Objectives: 1) To characterize the effect of gentle, incremental increases in sternal chest pressure on intrathoracic pressure in mechanically ventilated children. 2) To characterize the effect of gentle, incremental increases in sternal pressure on regional perfusion pressures, when existing catheters (arterial, central venous, intracranial) are present.
Study Design/Setting/Participants: This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR)settings at the Children's Hospital of Philadelphia. The participants are a convenience sample of stable mechanically ventilated children from 6 months to < 8 years of age. A total of 20 patients will be enrolled, including a minimum of 10 with vascular catheters.
Study Measures: The primary outcome variable is the change in intrathoracic pressure with incremental increase in gentle sternal pressure, measured by the peak airway pressure detected at the proximal end of the tracheal tube during end inspiration. Secondary outcomes include additional measures of intrathoracic pressure (end inspiratory pressure, mean pressure, area under the curve over 15 seconds, plateau pressure). For patients with indwelling central venous, arterial or intracranial pressure monitors, perfusion pressure changes will also be analyzed.
- Conditions
- Respiration, Artificial
- Keywords
- leaning, CPR, sternal pressure, incomplete release, chest compressions, pediatric
- Medical subject headings
- Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal Force Associated With Change in Intrathoracic Pressure.
The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.
Measured: per case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical
- Investigators
- Vinay Nadkarni, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628407
- Sponsor's protocol ID
- 2006-10-5023
- Acronym
- SWP
- Status last verified
- Mar 2011
- First submitted
- 26 Feb 2008
- Last updated
- 11 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sutton RM, Niles D, Nysaether J, Stavland M, Thomas M, Ferry S, Bishnoi R, Litman R, Allen J, Srinivasan V, Berg RA, Nadkarni VM. Effect of residual leaning force on intrathoracic pressure during mechanical ventilation in children. Resuscitation. 2010 Jul;81(7):857-60. doi: 10.1016/j.resuscitation.2010.03.015. Epub 2010 Apr 20.
PubMed 20409628
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gentle Sternal Chest Wall Pressure on Intrathoracic Pressure During Mechanical Ventilation in Children.
- ClinicalTrials.gov ID
- NCT00628407
- Acronym / sponsor ID
- SWP / 2006-10-5023
- Conditions
- Respiration, Artificial
- Keywords
- leaning, CPR, sternal pressure, incomplete release, chest compressions, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Laerdal Medical
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 1 Mar 2011
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, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR) settings at the Children's Hospital of Philadelphia (CHOP). We propose to observe, measure and report the effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other surrogates of hemodynamic function, in stable mechanically ventilated children. This study will provide preliminary data to inform the resuscitation research community and assist development of evidence-based pediatric resuscitation guidelines in the future.
Detailed description
Context: Survival outcome following cardiac arrest in children is poor, and recent evidence suggests that the quality of Cardiopulmonary Resuscitation(CPR) is critically important. Venous blood return to the thorax to refill the heart is essential for good quality CPR and critical organ perfusion. Adult cardiac arrest studies suggest that incomplete chest wall decompression (i.e. "leaning" on the sternum of the chest) during CPR affects intrathoracic pressure and impedes venous return. The consequence of "leaning" on the chest during CPR is increased intrathoracic pressure, which creates a "back-pressure" preventing optimal return of blood to the heart. The critical importance of manipulating positive and negative intrathoracic pressures during Cardiopulmonary Resuscitation (CPR) has been recently demonstrated in both animal and human studies. Food and Drug Administration (FDA) approved defibrillators with a force and depth sensor can monitor the depth, rate and complete release of sternal pressure during CPR. These FDA approved defibrillators have been introduced and implemented in the Pediatric Intensive Care Unit (PICU) at the Children's Hospital of Philadelphia (CHOP). These defibrillators can provide feedback on the force and amount of "leaning", but there is no data on the minimal amount of sternal pressure (or "leaning pressure") that affects intrathoracic or intravascular pressures or venous return to the heart. In addition, there is no data on how much force on the sternal pressure sensor (e.g. leaning on the sensor) begins to affect intrathoracic pressure in children. We propose to observe, measure and report the effect of incremental gentle sternal pressure increases on intrathoracic pressure, and other surrogates of hemodynamic function, in stable but critically ill and mechanically ventilated children. This study will provide preliminary data to inform the resuscitation research community and assist development of evidence-based pediatric resuscitation guidelines in the future.
Objectives: 1) To characterize the effect of gentle, incremental increases in sternal chest pressure on intrathoracic pressure in mechanically ventilated children. 2) To characterize the effect of gentle, incremental increases in sternal pressure on regional perfusion pressures, when existing catheters (arterial, central venous, intracranial) are present.
Study Design/Setting/Participants: This protocol is a prospective, pilot, observational study in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and the Operating Room (OR)settings at the Children's Hospital of Philadelphia. The participants are a convenience sample of stable mechanically ventilated children from 6 months to < 8 years of age. A total of 20 patients will be enrolled, including a minimum of 10 with vascular catheters.
Study Measures: The primary outcome variable is the change in intrathoracic pressure with incremental increase in gentle sternal pressure, measured by the peak airway pressure detected at the proximal end of the tracheal tube during end inspiration. Secondary outcomes include additional measures of intrathoracic pressure (end inspiratory pressure, mean pressure, area under the curve over 15 seconds, plateau pressure). For patients with indwelling central venous, arterial or intracranial pressure monitors, perfusion pressure changes will also be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any patient in the Pediatric Intensive Care Unit (PICU), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable, mechanically ventilated children in the Children's Hospital of Philadelphia.
Key inclusion criteria (6 listed)
- Age 6 months to < 8 years.
- Weight greater than 4.8 kg.
- Hemodynamically stable (defined by the Pediatric Critical Care Team, Anesthesiologists and Surgeons)
- Volume Limited Ventilation Mode on Conventional Mechanical Ventilator
- Vascular catheters in place (for at least 10 subjects)
Key exclusion criteria (1 listed)
- Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery, chest tube in place)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sternal Force Associated With Change in Intrathoracic Pressure.
Time frame: per case
The mean sternal force (measured in kg as a surrogate for Newtons [1kg = 9.81 newtons]) associated with a ≥2cm H2O peak endotracheal pressure (ETP) change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20409628Sutton RM, Niles D, Nysaether J, Stavland M, Thomas M, Ferry S, Bishnoi R, Litman R, Allen J, Srinivasan V, Berg RA, Nadkarni VM. Effect of residual leaning force on intrathoracic pressure during mechanical ventilation in children. Resuscitation. 2010 Jul;81(7):857-60. doi: 10.1016/j.resuscitation.2010.03.015. Epub 2010 Apr 20.
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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.
Vinay Nadkarni, 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?
An observational study of Respiration, Artificial, 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 6 inclusion and 1 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 11 Mar 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?
Yes. Results are posted in the registry (first posted 1 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sternal Force Associated With Change in Intrathoracic Pressure. (time frame: per case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628407, which also lists 1 linked publication.
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 11 Mar 2011.