Effects of Sternal Wall Pressure in Children

NCT00628407 | Completed Results

• 1 other identifier: 2006-10-5023
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Respiration, Artificial

Keywords

leaning; CPR; sternal pressure; incomplete release; chest compressions; pediatric

Outcome Measures

Primary Outcomes (1)

• 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.

  per case

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery, chest tube in place)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Laerdal Medical: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 20409628 RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vinay Nadkarni, MD
• Organization: Children's Hospital of Philadelphia

nadkarni@email.chop.edu

215-590-7430

Study Officials

• Vinay Nadkarni, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 5, 2008
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 11, 2011
• Results First Posted: March 1, 2011

Record last verified: 2011-03

Locations

US (1)