Effects of Sternal Wall Pressure in Children (SWP)

This study has been completed.
Sponsor:
Collaborator:
Laerdal Medical
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00628407
First received: February 26, 2008
Last updated: March 9, 2011
Last verified: March 2011
Results First Received: November 18, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Respiration, Artificial

  Participant Flow
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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
  Description
Sternal Wall Pressure Subjects that received gentle incremental sternal wall pressure.

Participant Flow:   Overall Study
    Sternal Wall Pressure  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Sternal Wall Pressure No text entered.

Baseline Measures
    Sternal Wall Pressure  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     13  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  2.2  ± 2  
Gender  
[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
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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
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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
e-mail: nadkarni@email.chop.edu


Publications of Results:
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. Epub 2010 Apr 20.


Responsible Party: Vinay Nadkarni, MD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00628407     History of Changes
Other Study ID Numbers: 2006-10-5023
Study First Received: February 26, 2008
Results First Received: November 18, 2010
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board