Sternal Wall Pressure in the Cath Lab

NCT01117883 | Completed

• 1 other identifier: 09-007428
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 resuscitation community on reasonable target pressures to avoid "leaning" on the chest during pediatric CPR.

Conditions

Perfusion Pressures; Central Venous Pressure; Cardiac Output; CPR; Cardiac Arrest

Keywords

Perfusion pressures; central venous pressure; cardiac output; CPR; cardiac arrest; Leaning; incomplete release

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in central hemodynamic measurements with application of two different sternal weights.

  1 yr

Secondary Outcomes (1)

• The secondary endpoint is the change in end-expiratory intrathoracic pressure with application of two different sternal weights.

  1 yr

Interventions

Application of two different sternal weights OTHER

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.

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months to \< 8 years.
• Weight 5 to 50 kilograms.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Laerdal Foundation for Acute Care Medicine: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Andy Glatz, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 6, 2010
• Study Start: April 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 14, 2011

Record last verified: 2011-07

Locations

US (1)