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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00628407 |
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Date of registration:
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26/02/2008 |
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Primary sponsor: |
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Public title:
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Effects of Sternal Wall Pressure in Children
SWP |
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Scientific title:
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Effect of Gentle Sternal Chest Wall Pressure on Intrathoracic Pressure During Mechanical Ventilation in Children. |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00628407 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Vinay Nadkarni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with contraindication to gentle, direct chest wall pressure (e.g. fresh sternotomy, recent chest wall surgery, chest tube in place)
Age minimum:
6 Months
Age maximum:
7 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Respiration, Artificial
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Primary Outcome(s)
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Sternal Force Associated With Change in Intrathoracic Pressure.
[Time Frame: per case]
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Secondary ID(s)
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2006-10-5023
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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