Effects of Sternal Wall Pressure in Children (SWP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628407
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : March 1, 2011
Last Update Posted : March 11, 2011
Laerdal Medical
Information provided by:
Children's Hospital of Philadelphia

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Respiration, Artificial

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Potential subjects were screened from January 1, 2007-June 2, 2008 using the protocol inclusion and exclusion criteria. Any patient in the PICU (7 South or 7 East), Progressive Care Unit (PCU) and Operating Room (OR) settings involving stable but critically ill, mechanically ventilated children from 6 months to < 8 years of age.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Sternal Wall Pressure Subjects that received gentle incremental sternal wall pressure.

Participant Flow:   Overall Study
    Sternal Wall Pressure

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Sternal Wall Pressure No text entered.

Baseline Measures
   Sternal Wall Pressure 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   13 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 2.2  (2) 
[Units: Participants]
Female   1 
Male   12 
Region of Enrollment 
[Units: Participants]
United States   13 

  Outcome Measures

1.  Primary:   Sternal Force Associated With Change in Intrathoracic Pressure.   [ Time Frame: per case ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Vinay Nadkarni, MD
Organization: Children's Hospital of Philadelphia
phone: 215-590-7430

Publications of Results:

Responsible Party: Vinay Nadkarni, MD, Children's Hospital of Philadelphia Identifier: NCT00628407     History of Changes
Other Study ID Numbers: 2006-10-5023
First Submitted: February 26, 2008
First Posted: March 5, 2008
Results First Submitted: November 18, 2010
Results First Posted: March 1, 2011
Last Update Posted: March 11, 2011