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Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT01287572
Recruitment Status : Unknown
Verified January 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 1, 2011
Last Update Posted : February 1, 2011
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Pediatric patients admitted to the intensive care unit and requiring conscious sedation for minor surgical procedures are at risk to hypoventilate and retain CO2.

The rise in CO2 levels is not well described and unpredicted. In this study the investigators will monitor CO2 levels transcutaneously using SDMS (SenTec digital Monitoring System) a device recently approved for clinical use. The hypothesis is ventilation of patients undergoing conscious sedation is compromised and CO2 levels might rise significantly to levels that potentially can effect hemodynamics.

In order to avoid hemodynamic changes proper and routine monitoring is recommended.


Condition or disease
Conscious Sedation

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficiency of Ventilation During Conscious Sedation of Pediatric Patients Undergoing Minor Procedures in the Pediatric Intensive Care Unit
Study Start Date : February 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : August 2012
Groups and Cohorts
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Group/Cohort
Conscious sedation group
Pediatric patients 0 to 18 years requiring conscious sedation for procedures done in the pediatric ICU excluding burned patients or patients with severe eczema or other skin disease.


Outcome Measures
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Primary Outcome Measures :
  1. TcCO2 level [ Time Frame: One year ]
    Transcutaneous measurement of patients undergoing conscious sedation


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit and undergoing minor procedures
Criteria

Inclusion Criteria:

  • pediatric patirnts 0- 18 years admitted to the pediatric intensive care unit
  • patients requiring minor surgical procedures (e.g. bronchoscopy, central venous line placement, lumbar puncture, intracranial pressure monitoring device insertion)

Exclusion Criteria:

  • skin disease
  • burns to thorax
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287572


Contacts
Contact: Efraim Sadot, MD +97236974612 efraims@tasmac.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Efraim Sadot, MD    +97236974612    efraims@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Yakov Sivan, MD Tel-Aviv Sourasky Medical Center
Study Director: Efraim Sadot, MD Tel-Aviv Sourasky Medical Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Prof. Yakov Sivan, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01287572     History of Changes
Other Study ID Numbers: TASMC-10-YS-319-CTIL
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Tel-Aviv Sourasky Medical Center:
TcCO2
sedation
procedure
PICU