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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01287572
First received: January 24, 2011
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

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
Conscious Sedation

Study Type: Observational
Study Design: 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

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • TcCO2 level [ Time Frame: One year ] [ Designated as safety issue: No ]
    Transcutaneous measurement of patients undergoing conscious sedation


Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 24, 2011
Last Updated: January 31, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 23, 2014