Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit
Recruitment status was: Not yet recruiting
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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 |
- TcCO2 level [ Time Frame: One year ]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
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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 |
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
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
| Contact: Efraim Sadot, MD | +97236974612 | efraims@tasmac.health.gov.il |
| Israel | |
| Tel Aviv Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Efraim Sadot, MD +97236974612 efraims@tasmc.health.gov.il | |
| Principal Investigator: | Yakov Sivan, MD | Tel-Aviv Sourasky Medical Center |
| Study Director: | Efraim Sadot, MD | Tel-Aviv Sourasky Medical Center |
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 Submitted: | January 24, 2011 |
| First Posted: | February 1, 2011 |
| Last Update Posted: | February 1, 2011 |
| Last Verified: | January 2011 |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
TcCO2 sedation procedure PICU |