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NCT01287572 Clinical Trial

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

Conscious Sedation Clinical Trial

Official title:
Efficiency of Ventilation During Conscious Sedation of Pediatric Patients Undergoing Minor Procedures in the Pediatric Intensive Care Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01287572
Other study ID # TASMC-10-YS-319-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 24, 2011
Last updated January 31, 2011
Start date February 2011
Est. completion date August 2012

Study information
Verified date January 2011
Source Tel-Aviv Sourasky Medical Center
Contact Efraim Sadot, MD
Phone +97236974612
Email efraims@tasmac.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date August 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary TcCO2 level Transcutaneous measurement of patients undergoing conscious sedation One year No
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